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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening; up to week 20
Awards & highlights
SENS-NMO Trial Summary
This trial will study if a cannabinoid spray can improve spasticity, pain, spasms, mood, walking & sleep in adults with a certain type of NMOSD. Participants will take treatments & answer questionnaires remotely, & optionally have in-person exams & imaging.
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.Check my eligibility
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.See study design
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.
SENS-NMO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I experience moderate to severe muscle stiffness.
Select...
I have had muscle stiffness due to NMOSD for at least 6 months.
SENS-NMO Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean Numeric Rating Scale - Spasticity (NRS-S) scores from pre-treatment to post-treatment
Secondary outcome measures
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 moreOther outcome measures
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 moreSENS-NMO 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
Find a Location
Who is running the clinical trial?
Michael, Levy M.D.,Ph.D.Lead Sponsor
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,315 Total Patients Enrolled
Michael Levy, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
9 Previous Clinical Trials
206 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use contraception or remain abstinent for 3 months after my last dose.I do not have severe kidney or liver problems.My immediate family has a history of schizophrenia or similar conditions.You plan to give blood during the study.I have a condition with muscle stiffness that might affect the study results.My condition has been stable with no relapses for at least 6 months.I agree to not change my spasm-related medication dose during the study, unless my health changes significantly.My medication for muscle stiffness has been the same for the last 30 days but hasn't relieved my symptoms.I am 18 years old or older.You have a history of severe mental illnesses like schizophrenia or major psychotic disorders.You have tried to harm yourself in the past or currently have thoughts of harming yourself, or the doctor thinks you might try to harm yourself.I have been diagnosed with NMOSD according to international criteria.You have a history of drug or alcohol addiction, except for tobacco or occasional cannabis use.I have surgery planned that will need general anesthesia during the study.I have a history of serious heart conditions.I experience moderate to severe muscle stiffness.I have had muscle stiffness due to NMOSD for at least 6 months.You have used marijuana or other cannabis-based drugs within the 30 days before the study starts.You have had bad reactions to cannabinoids, ethanol, peppermint oil, or propylene glycol.I am taking a medication that is not allowed in the study and cannot stop it.I have not had a Botulinum Toxin injection in the last 4 months and am willing to avoid them during the study.The doctor believes that your muscle stiffness is caused by a specific type of nervous system disorder attack.I have been hospitalized for depression or anxiety in the last 2 years.I have a history of epilepsy or seizures.You have been tested and do not have a specific antibody called MOG-IgG, if you have a certain type of nervous system disorder without a different specific antibody called AQP4-IgG.
Research Study Groups:
This trial has the following groups:- Group 1: Nabiximols, then Placebo
- Group 2: Placebo, then Nabiximols
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals currently join this research project?
"The records on the clinicaltrials.gov website illustrate that this particular medical trial is no longer recruiting patients, though it was posted initially on April 1st 2024 and last updated August 2nd 2023. Nevertheless, there are 98 other studies actively searching for participants at present."
Answered by AI
Has the U.S. Food and Drug Administration sanctioned Nabiximols for therapeutic use?
"Nabiximols has been evaluated and scored a 2 for safety, as the trial is currently in Phase 2 with data supporting its security but not yet its efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I need help with my excruciating pain.
PatientReceived no prior treatments
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