Trial Outcomes & Findings for A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain. (NCT NCT00713323)
NCT ID: NCT00713323
Last Updated: 2023-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
38 weeks
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Sativex
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 Study
STARTED
|
380
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
146
|
Reasons for withdrawal
| Measure |
Sativex
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 Study
Adverse Event
|
75
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Lack of Efficacy
|
36
|
|
Overall Study
Low creatine clearance at screening
|
1
|
|
Overall Study
Withdrawn due to exclusion criteria 11
|
1
|
|
Overall Study
Surgery cured allodynic pain
|
1
|
|
Overall Study
Pain free
|
1
|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Pain resolved
|
1
|
|
Overall Study
Subject travelling to USA
|
1
|
|
Overall Study
Subject travelling to Dominica Republic
|
1
|
|
Overall Study
Treatment that may interact with Sativex
|
1
|
Baseline Characteristics
A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
Baseline characteristics by cohort
| Measure |
Sativex
n=380 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
287 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=5 Participants
|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
222 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=365 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment
|
-2.07 units on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=371 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)
|
-15.67 units on a scale
Standard Deviation 19.11
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=374 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)
|
-1.76 units on a scale
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: week 38Population: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=380 Participants
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).
|
|---|---|
|
Subject Global Impression of Change
Very much worse
|
4 participants
|
|
Subject Global Impression of Change
Very Much Improved
|
41 participants
|
|
Subject Global Impression of Change
Much Improved
|
107 participants
|
|
Subject Global Impression of Change
Slightly Improved
|
99 participants
|
|
Subject Global Impression of Change
No change
|
79 participants
|
|
Subject Global Impression of Change
Slightly worse
|
14 participants
|
|
Subject Global Impression of Change
Much worse
|
12 participants
|
|
Subject Global Impression of Change
Missing Information
|
24 participants
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=380 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment
|
0.07 units on a scale
Standard Deviation 0.208
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=380 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment
|
6.27 units on a scale
Standard Deviation 23.35
|
SECONDARY outcome
Timeframe: 42 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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).
Outcome measures
| Measure |
Sativex
n=380 Participants
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).
|
|---|---|
|
Incidence of Adverse Events as a Measure of Subject Safety
|
295 participants
|
SECONDARY outcome
Timeframe: 38 weeksPopulation: All subjects who received at least one dose of open-label Sativex were included in the analysis.
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.
Outcome measures
| Measure |
Sativex
n=356 Participants
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).
|
|---|---|
|
Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)
|
0.6 units on a scale
Standard Deviation 2.62
|
Adverse Events
Sativex
Serious events: 40 serious events
Other events: 295 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sativex
n=380 participants at risk
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).
|
|---|---|
|
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
INTESTINAL FUNCTIONAL DISORDER
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
OESOPHAGEAL DISCOMFORT
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
VOMITING
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
CHEST PAIN
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
PYREXIA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
CELLULITIS
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
PNEUMONIA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER RECURRENT
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEURILEMMOMA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
AMNESIA
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
CAROTID ARTERY OCCLUSION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
CERVICAL ROOT PAIN
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
DIABETIC COMA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
FACIAL PARESIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
HEADACHE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
PARAPLEGIA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
SOMNOLENCE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
SPINAL CORD INFARCTION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
DISORIENTATION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
PARANOIA
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.53%
2/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
HYPERTENSION
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.26%
1/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
Sativex
n=380 participants at risk
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).
|
|---|---|
|
Nervous system disorders
Dizziness
|
20.8%
79/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dysgeusia
|
7.6%
29/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
7.4%
28/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Headache
|
6.1%
23/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Balance Disorder
|
3.2%
12/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Memory Impairment
|
3.2%
12/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
42/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.9%
30/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
25/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
17/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
4.2%
16/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
8.2%
31/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling Drunk
|
5.5%
21/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
15/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
13/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Disorientation
|
5.0%
19/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Depressed Mood
|
3.4%
13/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Insomnia
|
3.4%
13/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Depression
|
3.2%
12/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Dissociation
|
2.6%
10/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.9%
11/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
11/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
14/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
11/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.6%
10/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.2%
12/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Injury, poisoning and procedural complications
Accident
|
2.9%
11/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Vascular disorders
Hypertension
|
2.6%
10/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
14/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
4.5%
17/380 • 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.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
Additional Information
Mr Richard Potts, Clinical Operations Director
GW Pharma Ltd.
Phone: 0044 1223 266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER