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

NCT00391079 | Completed Phase 3 Results

• 1 other identifier: GWMS0501
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Sclerosis

Keywords

Central Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Change in Mean Pain Due to MS NRS Score

  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.

  14 weeks: Baseline - End of Treatment (last 7 days of treatment)

• Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline

  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.

  14 weeks: Baseline - end of treatment (last 7 days)

Secondary Outcomes (5)

• 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)

Study Arms (2)

A

EXPERIMENTAL

Drug: Sativex

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sativex 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.

Also known as: GW-1000-02

A

Placebo 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.

Also known as: GA0034

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GW Pharmaceuticals Ltd: lead

Study Sites (6)

Multiple Sclerosis Program, Foothills Hospital SSB

Calgary, Alberta, T2N 2T9, Canada

Location

MS Clinic, UBC Purdy Pavilion

Vancouver, British Columbia, V6T 2B5, Canada

Location

Dalhousie MS Research Clinic

Halifax, Nova Scotia, B3H 1V8, Canada

Location

London Health Sciences Centre / University Hospital

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3 A 2B4, Canada

Location

Related Publications (1)

• Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21.

  PMID: 23180178 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Richard Potts Clinical Operations Director
• Organization: GW Pharmaceuticals

rp@gwpharm.com

+44 1223 266800

Study Officials

• Gerard S Barron, BSc

  GW Pharma Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 23, 2006
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 24, 2013
• Results First Posted: July 4, 2012

Record last verified: 2013-06

Locations

CA (6)