What side effects are associated with this type of intervention?

Common treatments for Neuromyelitis Optica Spectrum Disorder (NMOSD) include immunosuppressive therapies such as rituximab, mycophenolate mofetil, and azathioprine. These treatments can have side effects like increased risk of infections, gastrointestinal issues, and liver toxicity. Nabiximols, a cannabinoid spray being studied for NMOSD, may cause side effects such as dizziness, fatigue, dry mouth, and changes in mood. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuromyelitis Optica Spectrum Disorder (NMOSD), including eculizumab, inebilizumab, and satralizumab. These treatments primarily target the immune system to reduce inflammation and prevent relapses. While nabiximols, a cannabinoid spray, modulates the endocannabinoid system, there are no FDA-approved treatments for NMOSD that specifically use cannabinoids or modulate the endocannabinoid system. Therefore, nabiximols represents a novel approach in the treatment landscape for NMOSD.

What other types of research exist?

Promising novel alternatives to nabiximols for NMOSD patients include ketazolam, which has shown efficacy in treating spasticity in multiple sclerosis, and acetazolamide, which has been effective in treating paroxysmal dystonia in central demyelinating diseases. Both offer potential benefits for managing symptoms associated with NMOSD.

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Cannabinoid

Nabiximols for Neuromyelitis Optica Spectrum Disorder (SENS-NMO Trial)

Phase 2

Waitlist Available

Led By Michael Levy, MD, PhD

Research Sponsored by Michael, Levy M.D.,Ph.D.

Eligibility Criteria Checklist

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

Must have

Anti-spasticity regimen, if on medications, maintained at a stable dose for the 30 days prior to enrollment without adequate relief of spasticity symptoms

Confirmed diagnosis of NMOSD, meeting the International Panel for NMO Diagnosis (IPND) NMOSD criteria (Appendix 1), including NMOSD with AQP4-IgG, and NMOSD without AQP4-IgG

Must not have

Scheduled elective surgery or other procedures which require general anesthesia during the study period

History of myocardial infarction or clinically significant ischemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening; up to week 20

Summary

This trial tests a cannabinoid spray called nabiximols to help adults with a condition affecting the nervous system who have severe muscle stiffness. These patients often don't respond well to other treatments. The spray works by relaxing muscles through the body's natural system that controls movement and pain. Nabiximols, also known as Sativex, is a cannabis plant extract approved in several countries for various uses including muscle stiffness related to multiple sclerosis and as additional pain relief in advanced cancer.

Who is the study for?

Adults diagnosed with Neuromyelitis Optica Spectrum Disorders (NMOSD) who experience moderate to severe spasticity for at least 6 months can join. They must be stable on current medications, not planning pregnancy, and able to use electronic devices for remote study participation. Exclusions include certain psychiatric conditions, substance abuse history, significant heart or liver issues, recent cannabis use, and known allergies to trial medication components.

What is being tested?

The trial is testing nabiximols (a cannabinoid spray) against a placebo in treating spasticity from NMOSD. It aims to see if nabiximols improve symptoms like muscle stiffness, pain frequency of spasms, mood swings walking ability and sleep quality compared to a dummy spray. Participants will receive treatments by mail and complete questionnaires remotely.

What are the potential side effects?

Potential side effects of nabiximols may include dizziness, fatigue, feeling high or intoxicated due to the active cannabinoids it contains. There might also be local reactions where the spray is applied such as dry mouth or throat irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medication for muscle stiffness has been the same for the last 30 days but hasn't relieved my symptoms.

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I have been diagnosed with NMOSD according to international criteria.

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I experience moderate to severe muscle stiffness.

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I have had muscle stiffness due to NMOSD for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have surgery planned that will need general anesthesia during the study.

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I have a history of serious heart conditions.

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I am taking a medication that is not allowed in the study and cannot stop it.

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I have not had a Botulinum Toxin injection in the last 4 months and am willing to avoid them during the study.

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening; up to week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening; up to week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening; up to week 20 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 in mean Numeric Rating Scale - Spasticity (NRS-S) scores from pre-treatment to post-treatment

Secondary study objectives

Change in Floodlight-2 Minute Walk Test (2MWT) from pre-treatment to post-treatment

Change in Floodlight-5 U-Turn Test (5-UTT) from pre-treatment to post-treatment

Change in Numeric Rating Scale-Sleep Disruption (NRS-SD) from pre-treatment to post-treatment

+13 more

Other study objectives

Change in Lower Limb Muscle Tone-6 (LLMT-6) scores as measured by the modified Ashworth Scale scores from pre-treatment to post-treatment

Change in mean Floodlight-Draw a Shape Test (DaS) scores from pre-treatment to post-treatment

Change in mean Floodlight-Pinching Test (PT) scores from pre-treatment to post-treatment

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then NabiximolsExperimental Treatment2 Interventions

During Period 1, participants receive daily matched placebo spray, delivered by a pump action oromucosal spray. The first 2 weeks of Period 1 are the titration period with participants following pre-specified uptitration schedule, until they reach their individualized optimum daily dosage, with a maximum of 12 daily sprays. Following these 2 weeks, they continue the optimum dose for 4 weeks. Then, they undergo a 2-week washout period, and then, enter Period 2 where they receive the active nabiximols spray and again undergo a 2-week titration period, and a 4-week consistent daily dosage period.

Group II: Nabiximols, then PlaceboExperimental Treatment2 Interventions

During Period 1, participants receive daily nabiximols spray, delivered by a pump action oromucosal spray. The first 2 weeks of Period 1 are the titration period with participants following pre-specified uptitration schedule, until they reach their individualized optimum daily dosage, with a maximum of 12 daily sprays. Following these 2 weeks, they continue the optimum dose for 4 weeks. Then, they undergo a 2-week washout period, and then, enter Period 2 where they receive the matched placebo spray and again undergo a 2-week titration period, and a 4-week consistent daily dosage period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nabiximols

2012

Completed Phase 3

~1930

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nabiximols, a cannabinoid spray containing a 1:1 ratio of THC and cannabidiol, modulates the endocannabinoid system by activating CB1 and CB2 receptors. This modulation can reduce spasticity, pain, and inflammation, which are significant symptoms in NMOSD. By targeting these receptors, nabiximols may help improve muscle control, reduce spasm frequency, and enhance overall quality of life for NMOSD patients. Other common treatments for NMOSD include immunosuppressive therapies like rituximab, which depletes B cells to reduce autoimmune attacks, and corticosteroids, which reduce inflammation during acute relapses. These treatments are crucial for managing the autoimmune nature of NMOSD and preventing further neurological damage.