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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

RELEASE MSS5 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

RELEASE MSS5 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change From Baseline in Blood Pressure

Change From Baseline in Clinical Laboratory Test Values

Change From Baseline in Electrocardiogram Parameters

+10 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

RELEASE MSS5 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GW Pharmaceuticals Ltd.Lead Sponsor

41 Previous Clinical Trials

8,219 Total Patients Enrolled

16 Trials studying Multiple Sclerosis

4,107 Patients Enrolled for Multiple Sclerosis

Jazz PharmaceuticalsLead Sponsor

248 Previous Clinical Trials

34,303 Total Patients Enrolled

17 Trials studying Multiple Sclerosis

4,107 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the conditions that Nabiximols is commonly used to help alleviate?

"Nabiximols is often used for patients who haven't responded well to traditional methods. However, it's also been shown to help with conditions such as multiple sclerosis, pain, and withdrawal from certain drugs."

Answered by AI

Are there any life-threatening risks associated with Nabiximols?

"Nabiximols has received a safety rating of 3 from our analysts at Power. This is due to the fact that Nabiximols is a Phase 3 trial, meaning that there is both efficacy and safety data available."

Answered by AI

Are there any precedents for Nabiximols clinical trials?

"Nabiximols was first trialled in 2012 at the Davidof Cancer Center. Since then, there have been 18350 completed trials with 113 active ones. A large number of these are based in Denver, Colorado."

Answered by AI

Are we still able to sign patients up for this research project?

"The latest information from clinicaltrials.gov shows that this particular trial is not currently enrolling patients. The study was first posted on 8/16/2021, and was last updated 11/2/2022. Although this trial is not presently looking for participants, there are 732 other trials that are."

Answered by AI

How many people are receiving lenalidomide in this clinical trial?

"Unfortunately, this particular clinical trial is not presently enrolling new patients. The trial was originally posted on 8/16/2021 and was most recently updated on 11/2/2022. However, there are 619 other trials actively looking for participants with sclerosis and 113 studies for Nabiximols that are still searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

2021. "Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984278.