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Cannabinoid

Nabiximols for Multiple sclerosis (RELEASE MSS5 Trial)

Phase 3

Waitlist Available

Research Sponsored by GW Pharmaceuticals Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (predose day 1 of treatment period 1) up to day 51 (end of treatment of treatment period 2)

Awards & highlights

Pivotal Trial

Summary

This trial will study the effects of a cannabis-based drug on muscle tone in people with multiple sclerosis.

Eligible Conditions

Multiple sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (predose day 1 of treatment period 1) up to day 51 (end of treatment of treatment period 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (predose day 1 of treatment period 1) up to day 51 (end of treatment of treatment period 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (predose day 1 of treatment period 1) up to day 51 (end of treatment of treatment period 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)

Secondary study objectives

Change From Baseline in Hematocrit Ratio

Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)

+1 more

Side effects data

From 2015 Phase 3 trial • 406 Patients • NCT01424566

27%

Neoplasm Progression

Weight Decreased

Asthenia

Somnolence

Decreased Appetite

Anaemia

Gastrointestinal Haemorrhage

Pneumonia

Catheter Site Cellulitis

Foot Fracture

Hydronephrosis

Deep Vein Thrombosis

Cerebrovascular Accident

Urosepsis

100%

80%

60%

40%

20%

Study treatment Arm

Double-blind Nabiximols

Double-blind Placebo (GA-0034)

Single-blind Nabiximols

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NabiximolsExperimental Treatment1 Intervention

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. Study dependent: Each spray delivers 100 microliters (μL) of nabiximols. A pre-determined number of sprays, but no less than 4 sprays, of nabiximols will be self-administered by participants as an oromucosal spray, under supervision of trial staff during 2 study visits to the trial site after they temporarily discontinued treatment with prescribed nabiximols (Sativex) as part of their regular medication.

Group II: PlaceboPlacebo Group1 Intervention

Placebo to match nabiximols is presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray delivers 100 μL containing no active ingredients.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nabiximols

2012

Completed Phase 3

~1930

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