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A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01610687
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : August 17, 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
Conditions Multiple Sclerosis
Spasticity
Intervention Drug: GW-1000-02
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GW-1000-02
Hide Arm/Group Description GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Period Title: Overall Study
Started 137
Completed 70
Not Completed 67
Reason Not Completed
Lack of Efficacy             26
Adverse Event             18
Moved out of area             6
Withdrawal by Subject             7
Lost to Follow-up             4
Symptom control without study medication             2
Unable to make journey             1
Death             1
Cannabis affecting job             1
Felt more alter without study medication             1
Arm/Group Title GW-1000-02
Hide Arm/Group Description Active treatment
Overall Number of Baseline Participants 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
<=18 years
0
   0.0%
Between 18 and 65 years
127
  92.7%
>=65 years
10
   7.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants
50.69  (9.531)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Female
83
  60.6%
Male
54
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 137 participants
137
1.Primary Outcome
Title Incidence of Adverse Events as a Measure of Patient Safety
Hide Description The number of patients who experienced an adverse event during the course of this extension study is presented
Time Frame up to1206 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: participants
126
2.Secondary Outcome
Title Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment
Hide Description A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.
Time Frame up to 1206 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 137
Mean (Standard Deviation)
Unit of Measure: sprays of study medication
8.09  (7.91)
3.Secondary Outcome
Title Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.
Hide Description Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.65  (14.15)
4.Secondary Outcome
Title Investigator Assessed Global Severity Score at Week 18
Hide Description The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: participants
92
5.Secondary Outcome
Title Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18
Hide Description A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
-31.34  (27.20)
6.Secondary Outcome
Title Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18
Hide Description A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
-27.81  (24.46)
7.Secondary Outcome
Title Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18
Hide Description A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.
Time Frame week 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-26.23  (23.90)
8.Secondary Outcome
Title Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18
Hide Description A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.
Arm/Group Title GW-1000-02
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: units on a scale
-33.60  (25.12)
Time Frame All adverse events occurring from during the extension study (up to 1049 days) 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
Hide Arm/Group Description Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
All-Cause Mortality
GW-1000-02
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW-1000-02
Affected / at Risk (%)
Total   23/137 (16.79%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/137 (0.73%) 
Cardiac disorders   
Atrial Fibrillation  1  1/137 (0.73%) 
Gastrointestinal disorders   
Vomiting NOS  1  2/137 (1.46%) 
Diarrhoea NOS  1  1/137 (0.73%) 
General disorders   
Fall  1  1/137 (0.73%) 
Oedema Peripheral  1  1/137 (0.73%) 
Weakness  1  1/137 (0.73%) 
Hepatobiliary disorders   
Biliary Cirrhosis Primary  1  1/137 (0.73%) 
Infections and infestations   
Urinary Tract Infection Not Otherwise Specified (NOS)  1  4/137 (2.92%) 
Pneumonia NOS  1  1/137 (0.73%) 
Bone infection NOS  1  1/137 (0.73%) 
Cellulitis  1  1/137 (0.73%) 
Injury, poisoning and procedural complications   
Femur Fracture  1  1/137 (0.73%) 
Lower Limb Fracture NOS  1  1/137 (0.73%) 
Head Injury  1  1/137 (0.73%) 
Metabolism and nutrition disorders   
Dehydration  1  1/137 (0.73%) 
Hyperglycaemia NOS  1  1/137 (0.73%) 
Musculoskeletal and connective tissue disorders   
Muscle Spasms  1  2/137 (1.46%) 
Muscle Weakness NOS  1  2/137 (1.46%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast Cancer Metastatic  1  1/137 (0.73%) 
Breast Cancer NOS  1  1/137 (0.73%) 
Lung Cancer Stage Unspecified (excl metastatic tumours to lung)  1  1/137 (0.73%) 
Nervous system disorders   
Multiple Sclerosis Relapse  1  3/137 (2.19%) 
Balance Impaired NOS  1  2/137 (1.46%) 
Convulsions NOS  1  1/137 (0.73%) 
Hypotonia  1  1/137 (0.73%) 
Psychiatric disorders   
Panic Attack  1  1/137 (0.73%) 
Psychotic Disorder NOS  1  1/137 (0.73%) 
Respiratory, thoracic and mediastinal disorders   
Pleurisy  1  1/137 (0.73%) 
Skin and subcutaneous tissue disorders   
Decubitus Ulcer  1  2/137 (1.46%) 
Vascular disorders   
Deep Vein Thrombosis NOS  1  1/137 (0.73%) 
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 3.6%
GW-1000-02
Affected / at Risk (%)
Total   127/137 (92.70%) 
Gastrointestinal disorders   
ORAL PAIN  1  32/137 (23.36%) 
DIARRHOEA NOS  1  27/137 (19.71%) 
NAUSEA  1  24/137 (17.52%) 
VOMITING NOS  1  16/137 (11.68%) 
GLOSSODYNIA  1  15/137 (10.95%) 
ORAL MUCOSAL DISORDER  1  15/137 (10.95%) 
CONSTIPATION  1  12/137 (8.76%) 
DRY MOUTH  1  11/137 (8.03%) 
ORAL DISCOMFORT  1  9/137 (6.57%) 
MOUTH ULCERATION  1  8/137 (5.84%) 
DYSPEPSIA  1  7/137 (5.11%) 
LOOSE STOOLS  1  7/137 (5.11%) 
TOOTHACHE  1  7/137 (5.11%) 
TOOTH DISCOLOURATION  1  6/137 (4.38%) 
General disorders   
FALL  1  21/137 (15.33%) 
FATIGUE  1  16/137 (11.68%) 
WEAKNESS  1  11/137 (8.03%) 
LETHARGY  1  10/137 (7.30%) 
APPLICATION SITE IRRITATION  1  9/137 (6.57%) 
APPLICATION SITE PAIN  1  6/137 (4.38%) 
MALAISE  1  6/137 (4.38%) 
FEELING ABNORMAL  1  5/137 (3.65%) 
Infections and infestations   
URINARY TRACT INFECTION NOS  1  56/137 (40.88%) 
NASOPHARYNGITIS  1  37/137 (27.01%) 
LOWER RESPIRATORY TRACT INFECTION NOS  1  13/137 (9.49%) 
TOOTH CARIES NOS  1  9/137 (6.57%) 
BACTERIAL INFECTION NOS  1  8/137 (5.84%) 
BLADDER INFECTION NOS  1  6/137 (4.38%) 
VAGINAL CANDIDIASIS  1  6/137 (4.38%) 
VIRAL INFECTION NOS  1  5/137 (3.65%) 
Investigations   
WEIGHT DECREASED  1  13/137 (9.49%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  10/137 (7.30%) 
Metabolism and nutrition disorders   
ANOREXIA  1  7/137 (5.11%) 
Musculoskeletal and connective tissue disorders   
PAIN IN LIMB  1  17/137 (12.41%) 
MUSCLE WEAKNESS NOS  1  13/137 (9.49%) 
ARTHRALGIA  1  12/137 (8.76%) 
BACK PAIN  1  10/137 (7.30%) 
MUSCLE SPASMS  1  7/137 (5.11%) 
JOINT SWELLING  1  5/137 (3.65%) 
MYALGIA  1  5/137 (3.65%) 
PERIPHERAL SWELLING  1  5/137 (3.65%) 
Nervous system disorders   
DIZZINESS  1  30/137 (21.90%) 
HEADACHE NOS  1  23/137 (16.79%) 
BALANCE IMPAIRED NOS  1  21/137 (15.33%) 
MULTIPLE SCLEROSIS AGGRAVATED  1  16/137 (11.68%) 
DYSGEUSIA  1  13/137 (9.49%) 
MULTIPLE SCLEROSIS RELAPSE  1  12/137 (8.76%) 
DISTURBANCE IN ATTENTION  1  9/137 (6.57%) 
SOMNOLENCE  1  9/137 (6.57%) 
SYNCOPE  1  9/137 (6.57%) 
MEMORY IMPAIRMENT  1  6/137 (4.38%) 
Psychiatric disorders   
SHORT-TERM MEMORY LOSS  1  9/137 (6.57%) 
DEPRESSED MOOD  1  7/137 (5.11%) 
DISORIENTATION  1  6/137 (4.38%) 
INSOMNIA  1  5/137 (3.65%) 
Respiratory, thoracic and mediastinal disorders   
PHARYNGITIS  1  8/137 (5.84%) 
THROAT IRRITATION  1  5/137 (3.65%) 
Skin and subcutaneous tissue disorders   
CONTUSION  1  12/137 (8.76%) 
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: NCT01610687     History of Changes
Other Study ID Numbers: GWMS0001 EXT
First Submitted: May 31, 2012
First Posted: June 4, 2012
Results First Submitted: July 11, 2012
Results First Posted: August 17, 2012
Last Update Posted: June 24, 2013