Phase 3
N=339
Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00391079 ↗Enrolled (actual)
339
Serious AEs
1.5%
Results posted
Jul 2012
Primary outcome: Primary: Change in Mean Pain Due to MS NRS Score — -2.02; -1.89 units on a scale — p=0.468
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sativex (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GW Pharmaceuticals Ltd
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Pain Due to MS NRS Score |
-2.02; -1.89 | 0.468 |
| PRIMARY Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline |
84; 77 | 0.2338 |
| SECONDARY Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) |
-14.24; -11.44 | 0.3103 |
| SECONDARY Change From Baseline to End of Treatment in Break-through Analgesia Usage |
-1.16; -1.02 | 0.1567 |
| SECONDARY Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form |
-1.5; -1.4 | 0.5643 |
| SECONDARY Change in Subject Global Impression of Change (SGIC) |
13; 8; 18; 15; 32; 25 | 0.0552 |
| SECONDARY Change in Sleep Disruption NRS |
-1.97; -2.02 | 0.8330 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00391079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.