A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.

NCT00711646 | Completed Phase 3 Results

• 1 other identifier: GWMS0106
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.

Conditions

Spasticity; Multiple Sclerosis

Keywords

Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.

  The spasticity Numerical Rating Scale 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 average spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline.

  0-52 days

Secondary Outcomes (6)

• Change From Baseline in Mean Ashworth Scale Score at the End of Treatment

  Days 0 - 52

• Change From Baseline in Mean Spasm Frequency Score at the End of Treatment

  Days 0 - 52

• Change From Baseline in Mean Motricity Index Score for the Arms

  Day 7 and 52

• Patient's Global Impression of Change in Condition at the End of Treatment

  Day 52

• Incidence of Adverse Events as a Measure of Subject Safety

  Day 0-52

Study Arms (2)

Sativex

EXPERIMENTAL

Drug: Sativex®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sativex® DRUG

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Also known as: GW-1000-02

Sativex

Placebo DRUG

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Also known as: GW-4001-01

Placebo

Eligibility Criteria

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

You may qualify if:

• Willing and able to give informed consent.
• Male or female, aged 18 years or above.
• Stable disease for at least three months prior to study entry, in the opinion of the investigator.
• Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the time of study entry.
• Significant spasticity in at least two muscle groups defined as a score of two or more on the Ashworth Scale for each muscle group.
• Stable dose of current anti-spasticity medication for at least 30 days prior to study entry.
• Willing to maintain a stable dose of anti-spasticity medication and level of physiotherapy for the duration of the study.
• Clinically acceptable laboratory results at Visit 2.
• Willing, if female and of child bearing potential or male subjects with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
• No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and were willing to abstain from any use of cannabis during the study.
• Able (in the investigators opinion) and willing to comply with all study requirements.
• Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
• Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Known history of alcohol or substance abuse.
• Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure.
• History of epilepsy.
• Female subject who was pregnant, lactating or planning pregnancy during the course of the study.
• Significant renal or hepatic impairment.
• Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
• Subject who was terminally ill or was inappropriate for placebo medication.
• Any other significant disease or disorder which, in the opinion of the investigator, either put the subject at risk because of participation in the study, or influenced the result of the study, or the subject's ability to participate in the study.
• Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide) therapy within seven days of study entry.
• Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the duration of the study.
• Subjects who were taking fentanyl (Durogesic®, Actiq®)
• Subjects who were taking antiarrhythmic medications.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
• Known or suspected adverse reaction to cannabinoids.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Royal Berkshire Hospital

Reading, Oxfordshire, RG1 5AN, United Kingdom

Location

Related Publications (2)

• Collin C, Davies P, Mutiboko IK, Ratcliffe S; Sativex Spasticity in MS Study Group. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol. 2007 Mar;14(3):290-6. doi: 10.1111/j.1468-1331.2006.01639.x.

  PMID: 17355549 RESULT

• Di Marzo V, Centonze D. Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes. CNS Neurosci Ther. 2015 Mar;21(3):215-21. doi: 10.1111/cns.12358. Epub 2014 Dec 4.

  PMID: 25475413 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma Ltd.

rp@gwpharm.com

0044 1223 266800

Study Officials

• Christine Collin, MB BS MRCP FRCP

  Royal Berkshire Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 9, 2008
• Study Start: June 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: May 6, 2023
• Results First Posted: September 14, 2012

Record last verified: 2023-04

Locations

GB (1)