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A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin

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: NCT01606176
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : August 24, 2012
Last Update Posted : September 3, 2012
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: Treatment
Conditions Pain
Multiple Sclerosis
Interventions Drug: GW-1000-02
Drug: Placebo
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg). Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Period Title: Overall Study
Started 36 34
Completed 32 31
Not Completed 4 3
Reason Not Completed
Adverse Event             2             3
Disease progression             1             0
Withdrawal by Subject             1             0
Arm/Group Title GW-1000-02 Placebo Total
Hide Arm/Group Description Active treatment. Placebo control. Total of all reporting groups
Overall Number of Baseline Participants 36 34 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  83.3%
26
  76.5%
56
  80.0%
>=65 years
6
  16.7%
8
  23.5%
14
  20.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 70 participants
51.72  (12.11) 57.61  (10.28) 54.58  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 70 participants
Female
20
  55.6%
21
  61.8%
41
  58.6%
Male
16
  44.4%
13
  38.2%
29
  41.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 36 participants 34 participants 70 participants
36 34 70
1.Primary Outcome
Title Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.
Hide Description Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 36 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.3  (1.67) -0.9  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.332
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-1.18 to 0.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Use of Analgesic Escape Medication.
Hide Description The percentage of days on treatment on which escape medication was used is presented.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 36 34
Mean (Standard Deviation)
Unit of Measure: percentage of days
20.57  (33.08) 50.12  (44.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -29.55
Confidence Interval (2-Sided) 95%
-48.08 to -11.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.
Hide Description Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 36 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.57  (0.85) -0.34  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.68 to 0.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.
Hide Description The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 28 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.9  (10.17) -3.2  (9.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.79
Confidence Interval (2-Sided) 95%
-8.14 to 2.56
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.
Hide Description The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (5.12) -1.9  (6.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.66
Confidence Interval (2-Sided) 95%
-4.42 to 1.10
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.
Hide Description The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.17) -0.4  (1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.387
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%
-0.36 to 0.91
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Patient Global Impression of Change at the End of 3 Weeks of Treatment.
Hide Description The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 36 34
Measure Type: Number
Unit of Measure: participants
9 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The proportion of patients who considered their condition “Very Much Improved” or “Much Improved” was compared between treatment groups using a Fisher’s Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.47
Confidence Interval (2-Sided) 95%
-21.56 to 18.51
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.
Hide Description Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 24 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (1.90) -0.8  (1.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.97 to 0.26
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Use of Analgesic Escape Medication - Multiple Sclerosis Subset.
Hide Description The percentage of days on treatment on which escape medication was used is presented.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 24 19
Mean (Standard Deviation)
Unit of Measure: percentage of days
16.71  (28.55) 48.48  (46.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The proportions were compared between treatment groups using ANOVA with treatment as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -31.77
Confidence Interval (2-Sided) 95%
-55.07 to -8.47
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.
Hide Description Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 24 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.60  (0.89) -0.36  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.80 to 0.16
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.
Hide Description The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.8  (11.26) -1.7  (6.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -5.18
Confidence Interval (2-Sided) 95%
-12.05 to 1.68
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.
Hide Description The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.5  (5.60) -0.5  (5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -3.77
Confidence Interval (2-Sided) 95%
-7.17 to -0.36
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.
Hide Description The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 21 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (1.01) 0.1  (1.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments

The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:

Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.79 to 0.88
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Patient Global Impression of Change - Multiple Sclerosis Subset.
Hide Description The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.
Time Frame 0 - 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 24 19
Measure Type: Number
Unit of Measure: participants
6 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The proportion of patients who considered their condition “Very Much Improved” or “Much Improved” was compared between treatment groups using a Fisher’s Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 3.95
Confidence Interval (2-Sided) 95%
-21.85 to 27.47
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Patient Safety.
Hide Description The number of patients who experienced an adverse event in the study is presented.
Time Frame 0 - 65 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
Overall Number of Participants Analyzed 36 34
Measure Type: Number
Unit of Measure: participants
35 26
Time Frame All adverse events occurring from the time of consent to post study follow up (0 -5 weeks) 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 Placebo
Hide Arm/Group Description Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period. Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
All-Cause Mortality
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   1/34 (2.94%) 
Infections and infestations     
Sepsis Not Otherwise Specified  1  0/36 (0.00%)  1/34 (2.94%) 
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 5%
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   35/36 (97.22%)   26/34 (76.47%) 
Eye disorders     
Vision Blurred  1  2/36 (5.56%)  0/34 (0.00%) 
Gastrointestinal disorders     
Nausea  1  5/36 (13.89%)  2/34 (5.88%) 
Dry Mouth  1  4/36 (11.11%)  0/34 (0.00%) 
Oral Discomfort  1  2/36 (5.56%)  0/34 (0.00%) 
Oral Pain  1  2/36 (5.56%)  2/34 (5.88%) 
Vomiting Not Otherwise Specified  1  2/36 (5.56%)  0/34 (0.00%) 
Diarrhoea Not Otherwise Specified  1  0/36 (0.00%)  3/34 (8.82%) 
General disorders     
Application Site Pain  1  4/36 (11.11%)  3/34 (8.82%) 
Fatigue  1  4/36 (11.11%)  0/34 (0.00%) 
Feeling Drunk  1  3/36 (8.33%)  0/34 (0.00%) 
Application Site Burning  1  2/36 (5.56%)  0/34 (0.00%) 
Feeling of Relaxation  1  2/36 (5.56%)  0/34 (0.00%) 
Lethargy  1  2/36 (5.56%)  0/34 (0.00%) 
Thirst  1  2/36 (5.56%)  0/34 (0.00%) 
Weakness  1  2/36 (5.56%)  0/34 (0.00%) 
Infections and infestations     
Urinary Tract Infection Not Otherwise Specified  1  4/36 (11.11%)  8/34 (23.53%) 
Investigations     
Gamma-Glutamyltransferase Increased  1  0/36 (0.00%)  2/34 (5.88%) 
Metabolism and nutrition disorders     
Appetite Increased  1  3/36 (8.33%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in Limb  1  0/36 (0.00%)  2/34 (5.88%) 
Back Pain Aggravated  1  0/36 (0.00%)  2/34 (5.88%) 
Peripheral Swelling  1  0/36 (0.00%)  2/34 (5.88%) 
Nervous system disorders     
Dizziness  1  20/36 (55.56%)  5/34 (14.71%) 
Headache Not Otherwise Specified  1  4/36 (11.11%)  5/34 (14.71%) 
Gait Abnormal Not Otherwise Specified  1  2/36 (5.56%)  0/34 (0.00%) 
Somnolence  1  2/36 (5.56%)  0/34 (0.00%) 
Dysgeusia  1  0/36 (0.00%)  2/34 (5.88%) 
Paraesthesia  1  0/36 (0.00%)  2/34 (5.88%) 
Psychiatric disorders     
Confusional State  1  3/36 (8.33%)  0/34 (0.00%) 
Euphoric Mood  1  2/36 (5.56%)  0/34 (0.00%) 
Paranoia  1  2/36 (5.56%)  0/34 (0.00%) 
Insomnia  1  0/36 (0.00%)  3/34 (8.82%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngitis  1  2/36 (5.56%)  0/34 (0.00%) 
Vascular disorders     
Hypertension Not Otherwise Specified  1  0/36 (0.00%)  2/34 (5.88%) 
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: NCT01606176     History of Changes
Other Study ID Numbers: GWPS0105
First Submitted: May 21, 2012
First Posted: May 25, 2012
Results First Submitted: July 19, 2012
Results First Posted: August 24, 2012
Last Update Posted: September 3, 2012