Phase 3
Completed N=339
Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
Source: ClinicalTrials.gov NCT00391079 ↗Enrolled (actual)
339
Serious AEs
1.5%
Results posted
Jul 2012
Primary outcomePrimary: Change in Mean Pain Due to MS NRS Score — -2.02; -1.89 units on a scale — p=0.468
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.
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 |
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. Informational only — not medical advice.