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An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients

NCT01610700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-01-12

Study results available
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Summary

A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Conditions

Interventions

DRUG

GW-1000-02

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.

DRUG

Placebo

Each actuation of placebo delivered the excipients only.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01610700 on ClinicalTrials.gov