A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple Sclerosis
Overview
- Phase
- Phase 3
- Intervention
- Sativex
- Conditions
- Multiple Sclerosis
- Sponsor
- GW Pharmaceuticals Ltd
- Enrollment
- 339
- Locations
- 6
- Primary Endpoint
- Change in Mean Pain Due to MS NRS Score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Intervention: Sativex
B
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Mean Pain Due to MS NRS Score
Time Frame: 14 weeks: Baseline - End of Treatment (last 7 days of treatment)
The pain 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 the number that best describes your 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 due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline.
Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline
Time Frame: 14 weeks: Baseline - end of treatment (last 7 days)
A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your 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 due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening.
Secondary Outcomes
- Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)(14 weeks: Baseline - End of treatment (Week 14))
- Change From Baseline to End of Treatment in Break-through Analgesia Usage(14 weeks: baseline - end of treatment (last 7 days))
- Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form(14 weeks: Baseline to end of treatment (last 7 days of treatment))
- Change in Subject Global Impression of Change (SGIC)(Week 14)
- Change in Sleep Disruption NRS(14 weeks; Baseline to end of treatment (last 7 days))