An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

Jazz Pharmaceuticals154 enrolled

Overview

An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.

Subjects who took part in GWMS0001 Part A were invited to continue to receive GW-1000-02 in this four-week open-label part of the study. Subjects received open-label cannabinoid extract (GW-1000-02) for four weeks, either with or without peppermint flavouring, according to their study centre. Subjects who completed the study could choose to continue receiving GW-1000-02 by entering the long-term safety extension follow-on study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Multiple Sclerosis

Interventions

GW-1000-02DRUG

Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged at least 18 years. * Multiple Sclerosis of any type. * Stable Multiple Sclerosis symptomatology during the four weeks before study entry. * Symptoms of the required severity (\>50 mm on a 100 mm Visual Analogue Scale severity scale) in least one of the specified impairment categories; spasticity, muscle spasms, disturbed bladder control, neuropathic pain, limb tremor. * A stable medication regime during the four weeks before study entry. * Willing to abstain from cannabis or cannabinoids for at least seven days before study entry, and during the study. * Agreed either to use effective contraception during the study and for three months thereafter, or had been surgically sterilised or, if female, were post-menopausal. * Clinically acceptable laboratory results for pre-study screening. * Willing and able to undertake and comply with all study requirements. * Willing and able to read, consider and understand the subject information and consent form and give written informed consent. Subjects unable to read or to sign the document procedures were treated as detailed in the Declaration of Helsinki. * Willing for their general practitioner, and consultant if appropriate, to be informed of study participation. * Willing for their name to be notified to Home Office for participation in the study. Exclusion Criteria: * Known or strongly suspected to be abusing drugs, including alcohol. * Not prepared to abstain from cannabis or cannabinoids during the study. * Current or past addiction to cannabis. * Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness. * History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness or personality disorder other than depression associated with chronic illness. * Received any drug containing levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®). * Serious cardiovascular disorder including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia. * Significant renal or hepatic impairment as shown in medical history or indicated by laboratory results. * History of epilepsy. * Terminal illness or other condition in which placebo medication would be inappropriate. * Pregnant, lactating or at risk of pregnancy. * Participated in any other clinical research study during the 12 weeks before study entry. * Planned hospital admission between study entry and Visit 6. * Planned travel outside the UK between study entry and Visit 6.

Locations (1)

Rivermead Rehabilitation Centre

Oxford, United Kingdom

Outcomes

Primary Outcomes

Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)

This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.