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An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01610713
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : September 19, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: GW-1000-02
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Period Title: Overall Study
Started 77 77
Completed 71 76
Not Completed 6 1
Reason Not Completed
Adverse Event             3             0
Lack of Efficacy             1             0
low mood and poor motivation             1             0
adv. to use original dose/amitriptyline             1             0
Lost to Follow-up             0             1
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL Total
Hide Arm/Group Description Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 77 77 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 77 participants 154 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
  93.5%
71
  92.2%
143
  92.9%
>=65 years
5
   6.5%
6
   7.8%
11
   7.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 77 participants 154 participants
50.9  (9.34) 50.7  (9.24) 50.8  (9.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 77 participants 154 participants
Female
45
  58.4%
49
  63.6%
94
  61.0%
Male
32
  41.6%
28
  36.4%
60
  39.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 77 participants 77 participants 154 participants
77 77 154
1.Primary Outcome
Title Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)
Hide Description This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 75 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.41  (24.20) -7.51  (24.75)
2.Secondary Outcome
Title Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.8  (4.93) 0.5  (5.35)
3.Secondary Outcome
Title Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 21 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (2.40) -0.1  (1.77)
4.Secondary Outcome
Title Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (1.95) 0.1  (2.42)
5.Secondary Outcome
Title Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.54  (1.98) -0.02  (1.72)
6.Secondary Outcome
Title Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 76 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.0  (4.25) -0.5  (3.86)
7.Secondary Outcome
Title Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 76 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.72) 0.1  (1.76)
8.Secondary Outcome
Title Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 71 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (4.73) 0.1  (5.23)
9.Secondary Outcome
Title Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 75 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (6.02) -0.8  (7.03)
10.Secondary Outcome
Title Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.25  (0.96) -0.15  (0.95)
11.Secondary Outcome
Title Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 76 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (1.77) 0.2  (1.89)
12.Secondary Outcome
Title Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 76 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (10.08) -0.6  (10.60)
13.Secondary Outcome
Title Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.74  (3.81) -0.20  (1.63)
14.Secondary Outcome
Title Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 56 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.3  (4.55) -1.7  (4.64)
15.Secondary Outcome
Title Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (5.24) 0.6  (6.21)
16.Secondary Outcome
Title Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.04  (20.13) -10.35  (30.28)
17.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Patient Safety
Hide Description The number of patients who recorded an adverse event during the 4 week open-label period is presented.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
This analyses set included all patients who took GW-1000-02 during the open-label treatment period.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 77 77
Measure Type: Number
Unit of Measure: participants
41 54
18.Secondary Outcome
Title Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.32  (23.78) -9.61  (28.98)
19.Secondary Outcome
Title Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 74 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.49  (24.78) -7.01  (27.52)
20.Secondary Outcome
Title Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 67 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.18  (24.03) -8.84  (23.70)
21.Secondary Outcome
Title Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 39 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.56  (21.40) -12.51  (24.81)
22.Secondary Outcome
Title Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 47 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.17  (24.18) -9.15  (24.48)
23.Secondary Outcome
Title Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.28  (22.81) -9.39  (25.71)
24.Secondary Outcome
Title Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 51 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.27  (23.92) -10.08  (24.37)
25.Secondary Outcome
Title Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment
Hide Description This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.
Time Frame End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 38 47
Mean (Standard Deviation)
Unit of Measure: time (seconds)
1.87  (10.12) 2.40  (9.58)
26.Secondary Outcome
Title Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment
Hide Description A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.
Time Frame End of Part B (week 10)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description:
Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Overall Number of Participants Analyzed 76 76
Measure Type: Number
Unit of Measure: participants
53 44
Time Frame All adverse events occurring during the four week Part B open-label period were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
Adverse Event Reporting Description All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
 
Arm/Group Title GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Hide Arm/Group Description Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
All-Cause Mortality
GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Affected / at Risk (%) Affected / at Risk (%)
Total   2/77 (2.60%)   0/77 (0.00%) 
Investigations     
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  1/77 (1.30%)  0/77 (0.00%) 
TRANSAMINASES INCREASED  1  1/77 (1.30%)  0/77 (0.00%) 
Musculoskeletal and connective tissue disorders     
MUSCLE SPASMS  1  1/77 (1.30%)  0/77 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
GW-1000-02 DB/OL Placebo DB/GW-1000-02 OL
Affected / at Risk (%) Affected / at Risk (%)
Total   41/77 (53.25%)   54/77 (70.13%) 
Ear and labyrinth disorders     
Vertigo  1  2/77 (2.60%)  2/77 (2.60%) 
Gastrointestinal disorders     
Nausea  1  6/77 (7.79%)  0/77 (0.00%) 
Diarrhoea not otherwise specified  1  4/77 (5.19%)  2/77 (2.60%) 
Vomiting Not Otherwise Specified  1  3/77 (3.90%)  0/77 (0.00%) 
Dry Mouth  1  2/77 (2.60%)  2/77 (2.60%) 
Dyspepsia  1  2/77 (2.60%)  0/77 (0.00%) 
Oral Discomfort  1  2/77 (2.60%)  2/77 (2.60%) 
Oral Pain  1  0/77 (0.00%)  2/77 (2.60%) 
General disorders     
Fatigue  1  0/77 (0.00%)  4/77 (5.19%) 
Weakness  1  0/77 (0.00%)  3/77 (3.90%) 
Feeling Abnormal  1  0/77 (0.00%)  3/77 (3.90%) 
Feeling Hot and Cold  1  2/77 (2.60%)  0/77 (0.00%) 
Malaise  1  2/77 (2.60%)  0/77 (0.00%) 
Application Site Pain  1  0/77 (0.00%)  2/77 (2.60%) 
Feeling Drunk  1  0/77 (0.00%)  2/77 (2.60%) 
Infections and infestations     
Nasopharyngitis  1  0/77 (0.00%)  3/77 (3.90%) 
Investigations     
Gamma-Glutamyltransferase Increased  1  2/77 (2.60%)  0/77 (0.00%) 
Nervous system disorders     
Dizziness  1  9/77 (11.69%)  21/77 (27.27%) 
Headache not otherwise specified  1  4/77 (5.19%)  4/77 (5.19%) 
Dysgeusia  1  0/77 (0.00%)  3/77 (3.90%) 
Somnolence  1  2/77 (2.60%)  3/77 (3.90%) 
Disturbance in Attention  1  2/77 (2.60%)  2/77 (2.60%) 
Balance Impaired Not Otherwise Specified  1  0/77 (0.00%)  2/77 (2.60%) 
Dysarthria  1  0/77 (0.00%)  2/77 (2.60%) 
Hypotonia  1  0/77 (0.00%)  2/77 (2.60%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngitis  1  0/77 (0.00%)  2/77 (2.60%) 
Vascular disorders     
Hypotension Not Otherwise Specified  1  0/77 (0.00%)  2/77 (2.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
Results Point of Contact
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
Phone: 0044 1223 266800
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01610713     History of Changes
Other Study ID Numbers: GWMS0001 Part B
First Submitted: May 31, 2012
First Posted: June 4, 2012
Results First Submitted: July 18, 2012
Results First Posted: September 19, 2012
Last Update Posted: June 24, 2013