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A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.

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: NCT00713323
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Pain
Peripheral Neuropathy
Intervention Drug: Sativex®
Enrollment 380
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex
Hide Arm/Group Description Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Period Title: Overall Study
Started 380
Completed 234
Not Completed 146
Reason Not Completed
Adverse Event             75
Withdrawal by Subject             15
Lost to Follow-up             11
Lack of Efficacy             36
Low creatine clearance at screening             1
Withdrawn due to exclusion criteria 11             1
Surgery cured allodynic pain             1
Pain free             1
Non-compliance             1
Pain resolved             1
Subject travelling to USA             1
Subject travelling to Dominica Republic             1
Treatment that may interact with Sativex             1
Arm/Group Title Sativex
Hide Arm/Group Description Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Baseline Participants 380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 380 participants
<=18 years
0
   0.0%
Between 18 and 65 years
287
  75.5%
>=65 years
93
  24.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 380 participants
57.8  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 380 participants
Female
180
  47.4%
Male
200
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 380 participants
United Kingdom 222
Belgium 9
Canada 5
Romania 50
Czech Republic 94
1.Primary Outcome
Title Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment
Hide Description The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 365
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.07  (2.13)
2.Secondary Outcome
Title Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)
Hide Description The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.67  (19.11)
3.Secondary Outcome
Title Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)
Hide Description The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 374
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.76  (2.93)
4.Secondary Outcome
Title Subject Global Impression of Change
Hide Description A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time Frame week 38
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 380
Measure Type: Number
Unit of Measure: participants
Very Much Improved 41
Much Improved 107
Slightly Improved 99
No change 79
Slightly worse 14
Much worse 12
Very much worse 4
Missing Information 24
5.Secondary Outcome
Title Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment
Hide Description The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 380
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.07  (0.208)
6.Secondary Outcome
Title Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment
Hide Description The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 380
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.27  (23.35)
7.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Subject Safety
Hide Description The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).
Time Frame 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 380
Measure Type: Number
Unit of Measure: participants
295
8.Secondary Outcome
Title Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)
Hide Description The patient was asked "on a scale of ‘0 to 10’ please indicate the average level of your intoxication due to medications over the last 24 hours" (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline.
Time Frame 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of open-label Sativex were included in the analysis.
Arm/Group Title Sativex
Hide Arm/Group Description:
Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (2.62)
Time Frame All adverse events (AEs) occurring from the time of consent to post study follow up i.e. 42 weeks were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of open-label treatment were also collected.
Adverse Event Reporting Description All AEs occurring during the study were reported on the running logs at the back of the study case report form.
 
Arm/Group Title Sativex
Hide Arm/Group Description Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
All-Cause Mortality
Sativex
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sativex
Affected / at Risk (%)
Total   40/380 (10.53%) 
Blood and lymphatic system disorders   
IDIOPATHIC THROMBOCYTOPENIC PURPURA  1  1/380 (0.26%) 
Cardiac disorders   
ANGINA PECTORIS  1  2/380 (0.53%) 
LEFT VENTRICULAR FAILURE  1  1/380 (0.26%) 
MYOCARDIAL INFARCTION  1  1/380 (0.26%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/380 (0.26%) 
DIARRHOEA  1  1/380 (0.26%) 
GASTRIC ULCER HAEMORRHAGE  1  1/380 (0.26%) 
HAEMATEMESIS  1  1/380 (0.26%) 
INTESTINAL FUNCTIONAL DISORDER  1  1/380 (0.26%) 
OESOPHAGEAL DISCOMFORT  1  1/380 (0.26%) 
PANCREATITIS ACUTE  1  1/380 (0.26%) 
VOMITING  1  1/380 (0.26%) 
General disorders   
CHEST PAIN  1  2/380 (0.53%) 
OEDEMA PERIPHERAL  1  2/380 (0.53%) 
PYREXIA  1  1/380 (0.26%) 
Infections and infestations   
CELLULITIS  1  2/380 (0.53%) 
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  2/380 (0.53%) 
CAMPYLOBACTER GASTROENTERITIS  1  1/380 (0.26%) 
LOCALISED INFECTION  1  1/380 (0.26%) 
ORAL FUNGAL INFECTION  1  1/380 (0.26%) 
PNEUMONIA  1  1/380 (0.26%) 
Investigations   
HEPATIC ENZYME INCREASED  1  1/380 (0.26%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  1/380 (0.26%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  1/380 (0.26%) 
HYPERGLYCAEMIA  1  1/380 (0.26%) 
Musculoskeletal and connective tissue disorders   
INTERVERTEBRAL DISC PROTRUSION  1  2/380 (0.53%) 
LUMBAR SPINAL STENOSIS  1  1/380 (0.26%) 
PAIN IN EXTREMITY  1  1/380 (0.26%) 
SPINAL OSTEOARTHRITIS  1  1/380 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
COLON CANCER  1  1/380 (0.26%) 
COLON CANCER RECURRENT  1  1/380 (0.26%) 
LUNG NEOPLASM MALIGNANT  1  1/380 (0.26%) 
METASTASES TO BONE  1  1/380 (0.26%) 
METASTASES TO LIVER  1  1/380 (0.26%) 
NEURILEMMOMA  1  1/380 (0.26%) 
Nervous system disorders   
AMNESIA  1  2/380 (0.53%) 
CAROTID ARTERY OCCLUSION  1  1/380 (0.26%) 
CEREBROVASCULAR ACCIDENT  1  1/380 (0.26%) 
CERVICAL ROOT PAIN  1  1/380 (0.26%) 
DIABETIC COMA  1  1/380 (0.26%) 
FACIAL PARESIS  1  1/380 (0.26%) 
HEADACHE  1  1/380 (0.26%) 
PARAPLEGIA  1  1/380 (0.26%) 
SOMNOLENCE  1  1/380 (0.26%) 
SPINAL CORD INFARCTION  1  1/380 (0.26%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/380 (0.26%) 
Psychiatric disorders   
DISORIENTATION  1  1/380 (0.26%) 
PARANOIA  1  1/380 (0.26%) 
SUICIDE ATTEMPT  1  1/380 (0.26%) 
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  1/380 (0.26%) 
Reproductive system and breast disorders   
PELVIC PAIN  1  1/380 (0.26%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  2/380 (0.53%) 
PULMONARY EMBOLISM  1  1/380 (0.26%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  2/380 (0.53%) 
HYPERTENSION  1  1/380 (0.26%) 
PERIPHERAL VASCULAR DISORDER  1  1/380 (0.26%) 
THROMBOPHLEBITIS  1  1/380 (0.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sativex
Affected / at Risk (%)
Total   295/380 (77.63%) 
Ear and labyrinth disorders   
Vertigo  1  14/380 (3.68%) 
Gastrointestinal disorders   
Nausea  1  42/380 (11.05%) 
Dry Mouth  1  30/380 (7.89%) 
Vomiting  1  25/380 (6.58%) 
Diarrhoea  1  17/380 (4.47%) 
Mouth Ulceration  1  16/380 (4.21%) 
General disorders   
Fatigue  1  31/380 (8.16%) 
Feeling Drunk  1  21/380 (5.53%) 
Infections and infestations   
Nasopharyngitis  1  15/380 (3.95%) 
Urinary Tract Infection  1  13/380 (3.42%) 
Lower Respiratory Tract Infection  1  17/380 (4.47%) 
Injury, poisoning and procedural complications   
Accident  1  11/380 (2.89%) 
Metabolism and nutrition disorders   
Hypoglycaemia  1  12/380 (3.16%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  11/380 (2.89%) 
Pain in extremity  1  11/380 (2.89%) 
Nervous system disorders   
Dizziness  1  79/380 (20.79%) 
Dysgeusia  1  29/380 (7.63%) 
Somnolence  1  28/380 (7.37%) 
Headache  1  23/380 (6.05%) 
Balance Disorder  1  12/380 (3.16%) 
Memory Impairment  1  12/380 (3.16%) 
Psychiatric disorders   
Disorientation  1  19/380 (5.00%) 
Depressed Mood  1  13/380 (3.42%) 
Insomnia  1  13/380 (3.42%) 
Depression  1  12/380 (3.16%) 
Dissociation  1  10/380 (2.63%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  14/380 (3.68%) 
Dyspnoea  1  11/380 (2.89%) 
Pharyngolaryngeal Pain  1  10/380 (2.63%) 
Vascular disorders   
Hypertension  1  10/380 (2.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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
Layout table for Results Point of Contact information
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
Phone: 0044 1223 266800
EMail: rp@gwpharm.com
Layout table for additonal information
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00713323     History of Changes
Other Study ID Numbers: GWCL0404 Part A
First Submitted: July 10, 2008
First Posted: July 11, 2008
Results First Submitted: July 11, 2012
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012