Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.

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Detailed Description

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GW has shown in phase II and III studies that Sativex has analgesic properties that are effective in relieving neuropathic pain. These studies suggested that Sativex is well tolerated and may also improve sleep and quality of life. GW is conducting this study to further demonstrate these effects.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

Sativex

Intervention Type DRUG

Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.

Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg.

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.

Interventions

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Sativex

Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.

Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg.

Intervention Type DRUG

Placebo

Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.

Intervention Type DRUG

Other Intervention Names

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GW-1000-02 GA0034

Eligibility Criteria

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Inclusion Criteria

* Any disease sub-type of MS of at least two years duration
* Central neuropathic pain (CNP) of at least three months and expected to remain stable for the study duration
* Moderate CNP defined by NRS pain score at baseline sum to at least 24
* Subject established on or previously tried and failed analgesic therapy for CNP
* If receiving disease modifying medications, stable dose for 3 months and maintained for study duration

Exclusion Criteria

* Subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia.
* Other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of CNP
* medical history suggests subject is likely to relapse/remit during course of study
* history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with MS
* known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids
* travel outside of the country of residence planned during the study
* significant cardiac, renal or hepatic impairment
* subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No