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

NCT ID: NCT00711646

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2004-03-31

Brief Summary

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

Detailed Description

This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal.

Conditions

Spasticity; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Sativex

Group Type: EXPERIMENTAL

Sativex®

Intervention Type: 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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Sativex®

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

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

GW-1000-02; GW-4001-01

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Planned travel outside the UK during the study (applicable to the UK centres only).
• Donation of blood during the study.
• Subjects who had participated in another research study in the 12 weeks prior to study entry.
• Subjects previously randomised into this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Collin, MB BS MRCP FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Berkshire Hospital

Locations

Royal Berkshire Hospital

Reading, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 17355549 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25475413 (View on PubMed)

Other Identifiers

GWMS0106

Identifier Type: -

Identifier Source: org_study_id