A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01599234
First received: May 10, 2012
Last updated: June 13, 2013
Last verified: June 2013
Results First Received: July 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Sativex
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sativex 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 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.

Participant Flow:   Overall Study
    Sativex     Placebo  
STARTED     167     170  
COMPLETED     150     155  
NOT COMPLETED     17     15  
Adverse Event                 9                 5  
Withdrawal by Subject                 2                 1  
Lost to Follow-up                 1                 2  
Lack of Efficacy                 2                 4  
Unable to operate spray                 1                 0  
Sponsor request as creatinine levels <50                 0                 1  
Death                 1                 0  
Patient would not stop driving                 1                 0  
Contra-indication discovered                 0                 1  
Pregnancy                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sativex 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 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Total Total of all reporting groups

Baseline Measures
    Sativex     Placebo     Total  
Number of Participants  
[units: participants]
  167     170     337  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     162     168     330  
>=65 years     5     2     7  
Age  
[units: years]
Mean ± Standard Deviation
  48.0  ± 10.06     47.1  ± 9.15     47.5  ± 9.61  
Gender  
[units: participants]
     
Female     106     101     207  
Male     61     69     130  
Region of Enrollment  
[units: participants]
     
United Kingdom     65     63     128  
Czech Republic     102     107     209  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)   [ Time Frame: 0-15 weeks ]

2.  Secondary:   Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline   [ Time Frame: 0-15 weeks ]

3.  Secondary:   Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment   [ Time Frame: Day 0 (Randomisation) and Day 99 (End of Treatment) ]

4.  Secondary:   Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)   [ Time Frame: 0-15 weeks ]

5.  Secondary:   Incidence of Adverse Events as a Measure of Subject Safety   [ Time Frame: 0-15 weeks ]

6.  Secondary:   Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment   [ Time Frame: Day 0 (Randomisation) and Day 99 (End of Treatment) ]

7.  Secondary:   Carer Global Impression of Change at the End of Treatment   [ Time Frame: Day 99 (end of treatment) ]

8.  Secondary:   Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment   [ Time Frame: Day 0 (Randomisation) and Day 99 (End of Treatment) ]

9.  Secondary:   Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline   [ Time Frame: 0 - 15 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
phone: 0044 1223 266800
e-mail: rp@gwpharm.com


Publications of Results:

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01599234     History of Changes
Other Study ID Numbers: GWCL0403
Study First Received: May 10, 2012
Results First Received: July 11, 2012
Last Updated: June 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control