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Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00702468
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : June 17, 2011
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 Spasticity
Multiple Sclerosis
Interventions Drug: Sativex
Drug: Placebo
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Period Title: Overall Study
Started 18 18
Completed 15 2
Not Completed 3 16
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
59.7  (8.97) 54.4  (10.42) 57.1  (9.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
9
  50.0%
12
  66.7%
21
  58.3%
Male
9
  50.0%
6
  33.3%
15
  41.7%
Duration of Multiple Sclerosis (MS)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
17.84  (8.48) 15.05  (10.07) 16.44  (9.29)
Duration of Spasticity  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
14.38  (9.90) 11.01  (8.25) 12.69  (9.14)
Expanded Disability Status Scale (EDSS) Score   [1] 
Median (Full Range)
Unit of measure:  Score on scale
Number Analyzed 18 participants 18 participants 36 participants
7.0
(4.0 to 8.5)
7.0
(5.5 to 8.5)
7.0
(4.0 to 8.5)
[1]
Measure Description: The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Baseline Spasticity Numerical Rating Scale (NRS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on scale
Number Analyzed 18 participants 18 participants 36 participants
3.60  (1.67) 4.13  (2.23) 3.87  (1.96)
[1]
Measure Description:

Spasticity NRS was completed daily by answering the following question:

“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’.

1.Primary Outcome
Title Number of Subjects Who Experience Treatment Failure.
Hide Description The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.
Time Frame Week 1- Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: Participants
8 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.335
Confidence Interval (2-Sided) 90%
0.162 to 0.691
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).
Hide Description

Spasticity NRS was completed daily by answering the following question:

“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity.

Time Frame Baseline (Week 1) to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: points on scale
1.11  (1.92) 1.10  (1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference
Estimated Value -0.21
Confidence Interval (2-Sided) 90%
-1.22 to 0.79
Estimation Comments Negative difference indicates the comparison is in favour of Sativex
3.Secondary Outcome
Title Change in Modified Ashworth Scale.
Hide Description

The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.

The change from baseline to end of study was assessed. The higher the score the better

Time Frame Day 7 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 17 8
Mean (Standard Deviation)
Unit of Measure: score on scale
21.5  (12.73) 22.9  (17.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.53
Confidence Interval (2-Sided) 90%
-4.68 to 5.74
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Motricity Index
Hide Description The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.
Time Frame Week 2 and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 16 7
Mean (Standard Deviation)
Unit of Measure: points on scale
Arm 72.4  (6.26) 92.5  (0)
Leg 43.6  (31.40) 47.0  (21.38)
5.Secondary Outcome
Title Timed 10-metre Walk.
Hide Description The time taken to travel 10 metres.
Time Frame Week 2 and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: Seconds
47.3  (50.29) 18.3  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.78
Confidence Interval (2-Sided) 90%
-14.52 to 10.96
Estimation Comments Negative difference indicates the comparison is in favour of Sativex
6.Secondary Outcome
Title Daily Sleep Disruption NRS
Hide Description Subjects will be asked: ”On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night” with the anchors 0 = ‘did not disrupt sleep’, 10 = ‘completely disrupted (unable to sleep at all)’.
Time Frame Week 1- Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: points on scale
2.90  (2.48) 3.36  (2.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter treatment difference
Estimated Value -0.64
Confidence Interval (2-Sided) 90%
-1.60 to 0.33
Estimation Comments A negative difference indicates the comparison is in favour of Sativex
7.Secondary Outcome
Title Subject Global Impressions of Change.
Hide Description

At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.

“Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below” The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.

Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: participants
Very much better 0 0
Much better 0 0
Minimally better 0 0
No change 6 1
Minimally worse 6 5
Much worse 5 9
Very much worse 1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.562
Confidence Interval (2-Sided) 90%
1.585 to 13.997
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Carer Global Impressions of Change for Functional Ability
Hide Description

The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):

  • How has the subject’s general functional abilities changed?”
  • How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 10 14
Measure Type: Number
Unit of Measure: paticipants
Very Much Better 0 0
Much Better 0 0
Minimally Better 0 0
No Change 3 0
Minimally Worse 5 3
Much Worse 2 9
Very Much Worse 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.550
Confidence Interval (2-Sided) 90%
3.942 to 118.773
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Carer Global Impressions of Change for Ease of Transfer
Hide Description

The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):

  • How has the subject’s general functional abilities changed?”
  • How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it.
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
Overall Number of Participants Analyzed 10 14
Measure Type: Number
Unit of Measure: paticipants
Very Much Better 0 0
Much Better 0 0
Minimally Better 0 0
No Change 3 2
Minimally Worse 5 5
Much Worse 2 6
Very Much Worse 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1151
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.444
Confidence Interval (2-Sided) 90%
0.948 to 13.718
Estimation Comments [Not Specified]
Time Frame All AEs occurring from the time of consent to post study follow up (Visit 3) i.e. 5 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of sudy medication were also collected.
Adverse Event Reporting Description All AEs occurring during the study were reported in the running logs at the back of the study case report form.
 
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
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   1/18 (5.56%)   0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1/18 (5.56%)  0/18 (0.00%) 
Pain in extremity  1/18 (5.56%)  0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/18 (83.33%)   14/18 (77.78%) 
Gastrointestinal disorders     
Diarrhoea  2/18 (11.11%)  1/18 (5.56%) 
Mouth Ulceration  1/18 (5.56%)  0/18 (0.00%) 
Stomach Discomfort  1/18 (5.56%)  0/18 (0.00%) 
Vomitting  1/18 (5.56%)  0/18 (0.00%) 
Nausea  0/18 (0.00%)  1/18 (5.56%) 
General disorders     
Fatigue  2/18 (11.11%)  0/18 (0.00%) 
Pain  2/18 (11.11%)  7/18 (38.89%) 
Application site pain  1/18 (5.56%)  0/18 (0.00%) 
Asthenia  0/18 (0.00%)  1/18 (5.56%) 
Gait disturbance  0/18 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Urinary tract infection  3/18 (16.67%)  0/18 (0.00%) 
Cystitis  1/18 (5.56%)  0/18 (0.00%) 
Lower respiratory tract infection  1/18 (5.56%)  0/18 (0.00%) 
Nasopharyngitis  1/18 (5.56%)  1/18 (5.56%) 
Oral Herpes  1/18 (5.56%)  0/18 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  0/18 (0.00%)  1/18 (5.56%) 
Investigations     
Gamma-glutamyltransferase increase  1/18 (5.56%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  3/18 (16.67%)  2/18 (11.11%) 
Back pain  3/18 (16.67%)  1/18 (5.56%) 
Musculoskeletal stiffness  2/18 (11.11%)  1/18 (5.56%) 
Joint stiffness  1/18 (5.56%)  0/18 (0.00%) 
Arthralgia  1/18 (5.56%)  0/18 (0.00%) 
Pain in extremity  1/18 (5.56%)  0/18 (0.00%) 
Musculoskeletal Discomfort  0/18 (0.00%)  1/18 (5.56%) 
Neck pain  0/18 (0.00%)  1/18 (5.56%) 
Sensation of heaviness  0/18 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Muscle spasticity  2/18 (11.11%)  3/18 (16.67%) 
Dizziness  1/18 (5.56%)  0/18 (0.00%) 
Somnolence  1/18 (5.56%)  0/18 (0.00%) 
Tremor  1/18 (5.56%)  0/18 (0.00%) 
Multiple Sclerosis  1/18 (5.56%)  0/18 (0.00%) 
Hyperaesthesia  0/18 (0.00%)  1/18 (5.56%) 
Paraesthesia  0/18 (0.00%)  1/18 (5.56%) 
Trigeminal neuralgia  0/18 (0.00%)  2/18 (11.11%) 
Psychiatric disorders     
Depressed mood  0/18 (0.00%)  2/18 (11.11%) 
Insomnia  0/18 (0.00%)  1/18 (5.56%) 
Sleep disorder  0/18 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders     
Haematuria  1/18 (5.56%)  0/18 (0.00%) 
Hypertonic Bladder  0/18 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1/18 (5.56%)  0/18 (0.00%) 
Epistaxis  1/18 (5.56%)  0/18 (0.00%) 
Pharyngolaryngeal pain  1/18 (5.56%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1/18 (5.56%)  0/18 (0.00%) 
Skin tightness  0/18 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hot flush  0/18 (0.00%)  1/18 (5.56%) 
Hypertension  0/18 (0.00%)  1/18 (5.56%) 
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: Richard Potts Clinical Operations Director
Organization: GW Pharma Ltd
Phone: +44 1353 616600
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00702468     History of Changes
Other Study ID Numbers: GWSP0702
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: March 14, 2011
Results First Posted: June 17, 2011
Last Update Posted: June 24, 2013