Trial Outcomes & Findings for A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury (NCT NCT01606202)

Last Updated: 2023-01-10

Results Overview

The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

116 participants

Primary outcome timeframe

Up to 51 days

Results posted on

2023-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	GW-1000-02 Each actuation of oromucosal spray delivers 2.7mg 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 130 mg : CBD 120 mg).	Placebo Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Study STARTED	56	60
Overall Study COMPLETED	49	57
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	GW-1000-02 Each actuation of oromucosal spray delivers 2.7mg 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 130 mg : CBD 120 mg).	Placebo Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Study Adverse Event	5	0
Overall Study Withdrawal by Subject	2	1
Overall Study Personal problems	0	1
Overall Study Problems with administration	0	1

Baseline Characteristics

A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GW-1000-02 n=56 Participants Active treatment.	Placebo n=60 Participants Placebo control.	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	55 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	48.7 years STANDARD_DEVIATION 12.97 • n=5 Participants	47.6 years STANDARD_DEVIATION 12.69 • n=7 Participants	48.1 years STANDARD_DEVIATION 12.69 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Region of Enrollment United Kingdom	49 participants n=5 Participants	51 participants n=7 Participants	100 participants n=5 Participants
Region of Enrollment Romania	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=55 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=59 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).	-0.74 units on a scale Standard Deviation 1.12	-0.69 units on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=55 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=59 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment	-4.68 percentage of days Standard Deviation 18.25	-2.91 percentage of days Standard Deviation 20.83

SECONDARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=42 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=48 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment	-0.50 units on a scale Standard Deviation 1.46	-0.69 units on a scale Standard Deviation 1.59

SECONDARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=52 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=59 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment	-1.92 percentage of days Standard Deviation 20.01	-1.57 percentage of days Standard Deviation 22.62

SECONDARY outcome

Timeframe: 0 - 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=35 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=43 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.	-0.37 units on a scale Standard Deviation 1.25	-0.46 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=50 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=59 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment	0.86 percentage of days Standard Deviation 6.71	0.48 percentage of days Standard Deviation 14.76

SECONDARY outcome

Timeframe: Up to 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=40 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=44 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in Modified Ashworth Scale Score at the End of Treatment	-0.13 units on a scale Standard Deviation 0.43	-0.01 units on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: Up to 51 days

Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.

Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function . A negative value from baseline indicates a deterioration.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=55 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=58 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment	0.4 units on a scale Standard Deviation 2.79	0.2 units on a scale Standard Deviation 2.98

SECONDARY outcome

Timeframe: Up to 51 days

Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.

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 is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=55 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=58 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment	0.1 units on a scale Standard Deviation 1.41	0.1 units on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Up to 51 days

Population: All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.

Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=12 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=16 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment	-0.3 units on a scale Standard Deviation 2.73	1.2 units on a scale Standard Deviation 3.45

SECONDARY outcome

Timeframe: Up to 51 days

Population: All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.

The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=56 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=60 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment	30 participants	12 participants

SECONDARY outcome

Timeframe: 0 - 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

The Brief Pain Inventory 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 is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=53 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=57 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment	-3.1 units on a scale Standard Deviation 5.22	-1.2 units on a scale Standard Deviation 4.64

SECONDARY outcome

Timeframe: 0 - 51 days

Population: All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.

Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=55 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=59 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment	-0.41 units on a scale Standard Deviation 0.59	-0.38 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Up to 61 days

Population: All randomised patients who received at least one dose of study drug were included in the Safety population.

The number of patients who experienced an adverse event during the study is presented.

Outcome measures

Outcome measures
Measure	GW-1000-02 n=56 Participants Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=60 Participants Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Incidence of Adverse Events as a Measure of Patient Safety.	46 participants	29 participants

Adverse Events

GW-1000-02

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GW-1000-02 n=56 participants at risk Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.	Placebo n=60 participants at risk Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Blood and lymphatic system disorders Anaemia Not Otherwise Specified Aggravated	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	0.00% 0/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
General disorders Fall	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Infections and infestations Methicillin-resistant Staphylococcus aureus infection	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	0.00% 0/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Infections and infestations Bladder Infection Not Otherwise Specified	0.00% 0/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Infections and infestations Pneumonia Not Otherwise Specified	0.00% 0/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Injury, poisoning and procedural complications Tibia Fracture	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	0.00% 0/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Injury, poisoning and procedural complications Upper Limb Fracture Not Otherwise Specified	0.00% 0/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Nervous system disorders Dizziness	0.00% 0/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Psychiatric disorders Confusion	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	0.00% 0/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Psychiatric disorders Paranoia	1.8% 1/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	0.00% 0/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
Skin and subcutaneous tissue disorders Contusion	0.00% 0/56 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.	1.7% 1/60 • All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected. All adverse events occurring during the study were reported on the running logs at the back of the study case report form.

Other adverse events

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