Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00678795
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : September 21, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Detrusor Overactivity
Multiple Sclerosis
Interventions Drug: Sativex®
Drug: Placebo
Enrollment 135
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Period Title: Overall Study
Started 67 68
Completed 56 62
Not Completed 11 6
Reason Not Completed
Adverse Event             7             3
Withdrawal by Subject             3             0
Protocol Violation             0             1
Lost to Follow-up             0             1
Lack of Efficacy             1             1
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period. Total of all reporting groups
Overall Number of Baseline Participants 67 68 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
63
  94.0%
66
  97.1%
129
  95.6%
>=65 years
4
   6.0%
2
   2.9%
6
   4.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 68 participants 135 participants
48.61  (9.31) 46.79  (11.20) 47.69  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
Female
52
  77.6%
46
  67.6%
98
  72.6%
Male
15
  22.4%
22
  32.4%
37
  27.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 68 participants 135 participants
United Kingdom 35 33 68
Belgium 23 26 49
Romania 9 9 18
1.Primary Outcome
Title Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment
Hide Description To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: number of daily episodes
-1.08  (1.42) -0.99  (1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.47 to 0.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment
Hide Description Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame Daily diary entries throughout 10 week study period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: number of daily episodes
-1.91  (2.44) -1.12  (2.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.58 to 0.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment
Hide Description Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: number of daily episodes
-0.55  (0.75) -0.21  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.50 to -0.07
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment
Hide Description Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 48 55
Mean (Standard Deviation)
Unit of Measure: pads used daily
-0.88  (1.50) -0.73  (1.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.57 to 0.41
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)
Hide Description The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 59 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.21  (17.51) 9.58  (12.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 3.90
Confidence Interval (2-Sided) 95%
-1.65 to 9.46
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment
Hide Description Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = “no problems” and 10 = “intolerable problems”. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 61 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (2.16) -0.9  (2.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.16
Confidence Interval (2-Sided) 95%
-1.82 to -0.51
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Patient’s Global Impression of Change
Hide Description Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The numbers who scored 1, 2, or 3 are presented.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 63 67
Measure Type: Number
Unit of Measure: participants
51 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments For Patient Global Impression of Change, the proportions of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ were compared between treatment groups using Fisher’s Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 25.40
Confidence Interval (2-Sided) 95%
10.37 to 40.42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mean Number of Daily Voids at the End of Treatment
Hide Description Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Time Frame 0 - 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: number of daily episodes
-1.73  (1.95) -0.87  (1.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.47 to -0.23
Estimation Comments [Not Specified]
Time Frame All adverse events occurring from the extension study onset to the last study visit (up to 99 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 Sativex Placebo
Hide Arm/Group Description Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
All-Cause Mortality
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/67 (2.99%)   2/68 (2.94%) 
Gastrointestinal disorders     
Vomiting  1  0/67 (0.00%)  1/68 (1.47%) 
Metabolism and nutrition disorders     
Dehydration  1  1/67 (1.49%)  1/68 (1.47%) 
Nervous system disorders     
Transient Ischaemic Attack  1  1/67 (1.49%)  0/68 (0.00%) 
Dizziness  1  0/67 (0.00%)  1/68 (1.47%) 
Multiple Sclerosis Relapse  1  0/67 (0.00%)  1/68 (1.47%) 
Renal and urinary disorders     
Cystitis Haemorrhagic  1  1/67 (1.49%)  0/68 (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 2.9%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   48/67 (71.64%)   43/68 (63.24%) 
Ear and labyrinth disorders     
Vertigo  1  2/67 (2.99%)  0/68 (0.00%) 
Gastrointestinal disorders     
Vomiting Not Otherwise Specified  1  4/67 (5.97%)  2/68 (2.94%) 
Constipation  1  3/67 (4.48%)  0/68 (0.00%) 
Nausea  1  3/67 (4.48%)  3/68 (4.41%) 
Diarrhoea Not Otherwise Specified  1  2/67 (2.99%)  4/68 (5.88%) 
Abdominal Pain Upper  1  2/67 (2.99%)  0/68 (0.00%) 
Toothache  1  0/67 (0.00%)  2/68 (2.94%) 
General disorders     
Feeling Drunk  1  3/67 (4.48%)  0/68 (0.00%) 
Weakness  1  3/67 (4.48%)  2/68 (2.94%) 
Fatigue  1  0/67 (0.00%)  3/68 (4.41%) 
Application Site Pain  1  0/67 (0.00%)  3/68 (4.41%) 
Feeling Abnormal  1  2/67 (2.99%)  0/68 (0.00%) 
Chest Pain  1  0/67 (0.00%)  2/68 (2.94%) 
Pyrexia  1  0/67 (0.00%)  2/68 (2.94%) 
Infections and infestations     
Urinary tract infection Not Otherwise Specified  1  4/67 (5.97%)  7/68 (10.29%) 
Cystitis Not Otherwise Specified  1  3/67 (4.48%)  0/68 (0.00%) 
Nasopharyngitis  1  3/67 (4.48%)  0/68 (0.00%) 
Influenza  1  0/67 (0.00%)  2/68 (2.94%) 
Pharyngitis Viral Not Otherwise Specified  1  0/67 (0.00%)  2/68 (2.94%) 
Metabolism and nutrition disorders     
Anorexia  1  0/67 (0.00%)  2/68 (2.94%) 
Musculoskeletal and connective tissue disorders     
Neck Pain  1  0/67 (0.00%)  2/68 (2.94%) 
Nervous system disorders     
Dizziness  1  12/67 (17.91%)  5/68 (7.35%) 
Headache Not Otherwise Specified  1  5/67 (7.46%)  5/68 (7.35%) 
Balance Impaired Not Otherwise Specified  1  3/67 (4.48%)  0/68 (0.00%) 
Paraesthesia  1  3/67 (4.48%)  0/68 (0.00%) 
Multiple Sclerosis Relapse  1  0/67 (0.00%)  3/68 (4.41%) 
Disturbance in Attention  1  2/67 (2.99%)  0/68 (0.00%) 
Memory Impairment  1  2/67 (2.99%)  0/68 (0.00%) 
Somnolence  1  2/67 (2.99%)  2/68 (2.94%) 
Psychiatric disorders     
Disorientation  1  4/67 (5.97%)  0/68 (0.00%) 
Dissociation  1  4/67 (5.97%)  0/68 (0.00%) 
Confusion  1  2/67 (2.99%)  0/68 (0.00%) 
Skin and subcutaneous tissue disorders     
Sweating Increased  1  2/67 (2.99%)  0/68 (0.00%) 
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: NCT00678795     History of Changes
Other Study ID Numbers: GWMS0208
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: July 18, 2012
Results First Posted: September 21, 2012
Last Update Posted: June 24, 2013