NMO Spectrum DisorderPhase 2SENS-NMONCT05974293
A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders
A Phase 2 study testing Nabiximols in people with NMO Spectrum Disorder and Spasticity, Muscle, run by Michael, Levy M.D.,Ph.D. at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMO Spectrum Disorder, Spasticity, Muscle
- What is being tested?
- Nabiximols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Aged between 18 years or older, at the time of signing the informed consent
- Willing and able to give informed consent and to participate in all study procedures
- Moderate to severe spasticity, as defined by a score of > 3 on the 0-10 numerical rating scale for spasticity (NRS-S) at the time of screening
- Reports NMOSD-related spasticity symptoms ongoing for at least 6 months
- Spasticity is determined to be causally related to an NMOSD attack in the opinion of the investigator
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- No relapses, and otherwise stable disease (i.e. no significant recovery from relapse or other change in disability) for at least 6 months, in the opinion of the investigator
- Anti-spasticity regimen, if on medications, maintained at a stable dose for the 30 days prior to enrollment without adequate relief of spasticity symptoms.
- Willing to maintain a stable dose of non-study-related anti-spasticity medication for the duration of the study, barring significant changes to their medical condition.
- Willing to allow his or her primary care doctor and primary neurologist, if appropriate, to be notified of participation in the study.
- Documentation of negative MOG-IgG, if diagnosis is NMOSD without AQP4-IgG positive status. Participant with presumptive diagnosis of NMOSD without AQP4-IgG and no prior MOG IgG testing can have MOG testing sent, and be eligible for participation if this is negative.
- For women of childbearing potential: participants who are not lactating, not pregnant, and not planning to become pregnant in the next 8 months and who agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of nabiximols.
- For males with partners who are females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of nabiximols.
- Able to use the necessary electronic applications (either via smartphone, tablet, or desktop) and has an email address.
Who cannot join
- Consumption of cannabis herb or other cannabinoid-based drugs within 30 days prior to study entry.
- Unwillingness to abstain from consumption of cannabis herb or other cannabinoid-based drugs for the duration of the study.
- Known or suspected hypersensitivity or adverse reaction (including psychiatric adverse reactions) to cannabinoids or cannabinoid products, ethanol, peppermint oil or propylene glycol.
- Currently receiving a prohibited medication and unwilling or unable to stop for the duration of the study. Prohibited medications include: CYP3A4 inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, etc.; CYP3A4 inducers: rifampicin, phenobarbital, phenytoin, St. John's Wort. Of note, the CYP3A4 inducer carbamazepine is permitted, but a stable dosage must be maintained throughout the study (no as needed dosing permitted). Other prohibited medications: regular levodopa (Sinemet, Sinemet Plus, Levodopa, L-dopa, Madopar, Benserazide), sildenafil (Viagra), fentanyl, or antiarrhythmic medications.
- Receipt of an investigational medicinal product or participation in a therapeutic clinical trial within 30 days prior to the initial visit
- Received a Botulinum Toxin injection within four months prior to the screening visit or unwillingness to stop receiving Botulinum Toxin injections for the relief of spasticity for the duration of the study.
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- Personal medical history of schizophrenia, severe personality disorders, other major psychotic disorders, or other major psychiatric disorders other than depression and anxiety.
- Family history in 1st degree relatives of schizophrenia or other psychotic disorders.
- Hospitalization for depression or anxiety within the 2 years prior to the screening visit.
- A documented history of attempted suicide or suicidal ideation of category 4 or 5 according to the Columbia Suicide Severity Rating Scale (C-SSRS) screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.
- Known or suspected history of a substance use disorder or heavy alcohol consumption excluding tobacco use disorder or cannabis use not meeting criteria for cannabis use disorder.
- History of myocardial infarction or clinically significant ischemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure. .
- Significant renal or hepatic impairment, either in the opinion of the investigator, or by the following laboratory screening values: AST or ALT > 2 × upper limit of normal (ULN); Total bilirubin > 2 × ULN (unless due to Gilbert's syndrome); BUN > 2 × upper limit of normal (ULN)
- History of epilepsy or recurrent seizures.
- Concomitant disease or disorder that has symptoms of spasticity, and that in the opinion of the Investigator may influence the study outcome and endpoint assessment.
- Any other significant medical or psychiatric condition which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate in the study.
- Scheduled elective surgery or other procedures which require general anesthesia during the study period.
- Intention to donate blood during the study.
- Intention to travel internationally during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase IIb Study of the Safety and Efficacy of Nabiximols in Subjects With Spasticity Due to Neuromyelitis Optica Spectrum Disorders: A Double-blind, Randomized, Placebo-Controlled, Crossover Study
The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.
Read the detailed description
Patients with NMOSD often have medication-resistant and severe spasticity due to longitudinally extensive spinal cord lesions. Existing treatments are limited by their efficacy and tolerability. Cannabinoids have been shown to quantitatively improve spasticity in mouse models of neuroinflammation, and nabiximols, a cannabinoid-based oromucosal spray, have demonstrated efficacy for medication-resistant spasticity in multiple sclerosis. However, no studies have as yet explored the use of nabiximols specifically in NMOSD, and there is a significant unmet need for new symptomatic treatments in this patient population. The goal of this study is to evaluate the safety and efficacy of nabiximols spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and seronegative NMOSD. This study is designed as a phase IIb, single-site, double-blind, randomized, placebo-controlled 2x2 crossover clinical trial, with a 2-week washout period between treatment periods. After randomization, each participant enters into Period 1, which begins with a 2-week dose escalation period with a pre-defined dose escalation scheme, followed by a 4-week stable treatment period. After completion of Period 1, all participants have a 2-week washout period and then enter Period 2, where they again complete a 2-week dose escalation period and 4-week constant treatment period. The patient-reported 0-10 numeric rating scale for spasticity (NRS-S) is the primary outcome measure. All key study procedures are performed virtually, including a weekly electronic study diary, additional weekly surveys, and 8 virtual video-based study visits including a screening visit and safety follow up visit. Additional optional in-person assessments of spasticity (neurologic exam, modified Ashworth Scale and muscle ultrasound elastography) will be performed for a selection of local participants. In total, the study has a 20-week duration per participant, from the screening visit to the final study completion for safety follow-up visit, including 12 weeks of on-treatment time.
- Conditions
- NMO Spectrum Disorder, Spasticity, Muscle
- Being tested
- Nabiximols, Placebo
- Keywords
- Neuromyelitis Optica Spectrum Disorders, Nabiximols, Cannabinoid, Sativex
- Medical subject headings
- Neuromyelitis Optica, Muscle Spasticity, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiximolsDrug
Also called Sativex
Nabiximols is is a yellow-brown oromucosal spray solution containing 27 mg/mL of THC and 25 mg/mL of CBD.
PlaceboDrug
The placebo is a matching oromucosal spray that is identical to the investigational study product in terms of packaging, labelling, schedule of administration, dosing instructions, and appearance.
| Study group | Role | What they receive |
|---|---|---|
| Nabiximols, then Placebo | Experimental | 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. Receives: Drug: Nabiximols; Drug: Placebo |
| Placebo, then Nabiximols | Experimental | 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. Receives: Drug: Nabiximols; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Numeric Rating Scale - Spasticity (NRS-S) scores from pre-treatment to post-treatment
Numeric Rating Scale - Spasticity (NRS-S) score is a 0-10 point, patient-reported scale indicating spasticity severity.
Measured: Baseline; Up to week 18
Secondary outcomes (17)
Proportion of participants with NRS-S response corresponding to a minimal clinically important difference (MCID) (>18% difference) from pre-treatment to post-treatment
Numeric Rating Scale - Spasticity (NRS-S) score is a 0-10 point, patient-reported, single item scale indicating spasticity severity.
Measured: Baseline; Up to week 18
Proportion of participants with NRS-S response corresponding to a clinically important difference (CID) (>30% difference) from pre-treatment to post-treatment
Numeric Rating Scale - Spasticity (NRS-S) score is a 0-10 point, patient-reported scale indicating spasticity severity.
Measured: Baseline; Up to week 18
Change in Penn Spasm Frequency Scale (PSFS) score from pre-treatment to post-treatment
The Penn Spasm Frequency Scale (PSFS) is a 2-item patient-reported scale indicating spasm frequency and severity
Measured: Baseline; Up to week 18
Change in mean PROMIS NRS v1.0 - Pain Intensity 3a scores from pre-treatment to post-treatment
The PROMIS NRS v1.0 - Pain Intensity 3a form is a 3-item patient-reported scale indicating worst pain, average pain, and current pain in the prior week
Measured: Baseline; Up to week 18
Change in mean PROMIS SF v1.1 - Pain Interference 8a scores from pre-treatment to post-treatment
The PROMIS SF v1.1-Pain Interference 8a form is an 8-item scale indicating the degree to which pain interferes with functioning
Measured: Baseline; Up to week 18
Change in mean Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) sub-scale 2 (pain and discomfort) scores from pre-treatment to post-treatment
The Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) form sub-scale 2 (pain and discomfort) is a 9-item patient-reported scale indicating the impact of spasticity on pain and discomfort
Measured: Baseline; Up to week 18
Change in Floodlight-5 U-Turn Test (5-UTT) from pre-treatment to post-treatment
The Floodlight-5 U-Turn Test (5-UTT) is a smartphone application-based test that evaluates ambulation, and specifically turn speed in seconds
Measured: Baseline; Up to week 18
Change in Floodlight-2 Minute Walk Test (2MWT) from pre-treatment to post-treatment
The Floodlight-2 Minute Walk Test (2MWT) is is a smartphone application-based test that evaluates ambulation speed in seconds
Measured: Baseline; Up to week 18
Change in mean Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) sub-scale 5 (walking) scores from pre-treatment to post-treatment
The Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) form sub-scale 2 (pain and discomfort) is a 10-item patient-reported scale indicating the impact of spasticity on walking
Measured: Baseline; Up to week 18
Change in PROMIS SF v1.0 - Sleep Disturbance 4A from pre-treatment to post-treatment
The PROMIS SF v1.0 - Sleep Disruption 4A is a 4-item patient-reported scale indicating sleep quality
Measured: Baseline; Up to week 18
Change in Numeric Rating Scale-Sleep Disruption (NRS-SD) from pre-treatment to post-treatment
The Numeric Rating Scale-Sleep Disruption (NRS-SD) is a single-item 0-10 scale where participants can indicate the degree to which spasticity impacts sleep
Measured: Baseline; Up to week 18
Proportion of participants reporting 'very much improved,' 'much improved,' and 'slightly improved' symptoms in the Global Impression of Change (GIC) by subject (SGIC) scores from pre-treatment to post-treatment
The Global Impression of Change (GIC) by subject (SGIC) is a 7-point, single-item scale indicating the direction and degree of change that participants experience
Measured: Baseline; Up to week 18
Change in Visual Analogue Scale - Quality of Life (VAS-QL) from pre-treatment to post-treatment
The Visual Analogue Scale - Quality of Life (VAS-QL) is a 100mm visual analog scale ranging from 0 (very low) to 100 (very high) on which respondents record their perception of quality of life
Measured: Baseline; Up to week 18
Proportion of participants who are tolerant of treatment
Tolerance is defined as not discontinuing study drug and at least 50% compliance
Measured: Screening; Up to week 18
Proportion of participants who are tolerant of treatment
Tolerance is defined as not discontinuing study drug and at least 50% compliance
Measured: Screening; Up to week 20
Number of participants with treatment-emergent adverse events while on each treatment
Treatment-emergent adverse events will be tabulated for each arm during each study period and compared between treatment and placebo
Measured: Screening; Up to week 20
Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Screening and at each subsequent time-point with reference to the last assessment
The Columbia-Suicide Severity Rating Scale is assessment tool that evaluates suicidal ideation and behavior
Measured: Screening; Up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start31 Dec 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Why it stopped: Funding was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMO Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a phase II, single-site, double-blind, randomized, placebo-controlled 2 by 2 crossover clinical trial designed to evaluate the efficacy of nabiximols compared to placebo for the treatment of NMOSD-related spasticity.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael, Levy M.D.,Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor-investigator, Michael, Levy M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Michael Levy, MD, PhD, Principal investigator, Massachusetts General HospitalAnastasia Vishnevetsky, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974293
- Sponsor's protocol ID
- 2023P002959
- Acronym
- SENS-NMO
- Status last verified
- Jul 2025
- First submitted
- 26 Jul 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No specific plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Study of the Safety and Efficacy of Nabiximols in Subjects With Spasticity Due to Neuromyelitis Optica Spectrum Disorders: A Double-blind, Randomized, Placebo-Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT05974293
- Acronym / sponsor ID
- SENS-NMO / 2023P002959
- Conditions
- NMO Spectrum Disorder, Spasticity, Muscle
- Keywords
- Neuromyelitis Optica Spectrum Disorders, Nabiximols, Cannabinoid, Sativex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael, Levy M.D.,Ph.D.University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.
Detailed description
Patients with NMOSD often have medication-resistant and severe spasticity due to longitudinally extensive spinal cord lesions. Existing treatments are limited by their efficacy and tolerability. Cannabinoids have been shown to quantitatively improve spasticity in mouse models of neuroinflammation, and nabiximols, a cannabinoid-based oromucosal spray, have demonstrated efficacy for medication-resistant spasticity in multiple sclerosis. However, no studies have as yet explored the use of nabiximols specifically in NMOSD, and there is a significant unmet need for new symptomatic treatments in this patient population. The goal of this study is to evaluate the safety and efficacy of nabiximols spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and seronegative NMOSD. This study is designed as a phase IIb, single-site, double-blind, randomized, placebo-controlled 2x2 crossover clinical trial, with a 2-week washout period between treatment periods. After randomization, each participant enters into Period 1, which begins with a 2-week dose escalation period with a pre-defined dose escalation scheme, followed by a 4-week stable treatment period. After completion of Period 1, all participants have a 2-week washout period and then enter Period 2, where they again complete a 2-week dose escalation period and 4-week constant treatment period. The patient-reported 0-10 numeric rating scale for spasticity (NRS-S) is the primary outcome measure. All key study procedures are performed virtually, including a weekly electronic study diary, additional weekly surveys, and 8 virtual video-based study visits including a screening visit and safety follow up visit. Additional optional in-person assessments of spasticity (neurologic exam, modified Ashworth Scale and muscle ultrasound elastography) will be performed for a selection of local participants. In total, the study has a 20-week duration per participant, from the screening visit to the final study completion for safety follow-up visit, including 12 weeks of on-treatment time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase II, single-site, double-blind, randomized, placebo-controlled 2 by 2 crossover clinical trial designed to evaluate the efficacy of nabiximols compared to placebo for the treatment of NMOSD-related spasticity.
| Arm | Type | Receives |
|---|---|---|
| Nabiximols, then Placebo | Experimental | Drug: Nabiximols, Drug: PlaceboDuring 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. |
| Placebo, then Nabiximols | Experimental | Drug: Nabiximols, Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Aged between 18 years or older, at the time of signing the informed consent
- Willing and able to give informed consent and to participate in all study procedures
- Moderate to severe spasticity, as defined by a score of > 3 on the 0-10 numerical rating scale for spasticity (NRS-S) at the time of screening
- Reports NMOSD-related spasticity symptoms ongoing for at least 6 months
Key exclusion criteria (19 listed)
- Consumption of cannabis herb or other cannabinoid-based drugs within 30 days prior to study entry.
- Unwillingness to abstain from consumption of cannabis herb or other cannabinoid-based drugs for the duration of the study.
- Known or suspected hypersensitivity or adverse reaction (including psychiatric adverse reactions) to cannabinoids or cannabinoid products, ethanol, peppermint oil or propylene glycol.
- Currently receiving a prohibited medication and unwilling or unable to stop for the duration of the study. Prohibited medications include: CYP3A4 inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, etc.; CYP3A4 inducers: rifampicin, phenobarbital, phenytoin, St. John's Wort. Of note, the CYP3A4 inducer carbamazepine is permitted, but a stable dosage must be maintained throughout the study (no as needed dosing permitted). Other prohibited medications: regular levodopa (Sinemet, Sinemet Plus, Levodopa, L-dopa, Madopar, Benserazide), sildenafil (Viagra), fentanyl, or antiarrhythmic medications.
- Receipt of an investigational medicinal product or participation in a therapeutic clinical trial within 30 days prior to the initial visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NabiximolsAlso: SativexNabiximols is is a yellow-brown oromucosal spray solution containing 27 mg/mL of THC and 25 mg/mL of CBD. | Drug | Nabiximols, then Placebo, Placebo, then Nabiximols |
| PlaceboThe placebo is a matching oromucosal spray that is identical to the investigational study product in terms of packaging, labelling, schedule of administration, dosing instructions, and appearance. | Drug | Nabiximols, then Placebo, Placebo, then Nabiximols |
Primary outcome
Change in mean Numeric Rating Scale - Spasticity (NRS-S) scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Numeric Rating Scale - Spasticity (NRS-S) score is a 0-10 point, patient-reported scale indicating spasticity severity.
17 secondary outcomes
Proportion of participants with NRS-S response corresponding to a minimal clinically important difference (MCID) (>18% difference) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Proportion of participants with NRS-S response corresponding to a clinically important difference (CID) (>30% difference) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in Penn Spasm Frequency Scale (PSFS) score from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in mean PROMIS NRS v1.0 - Pain Intensity 3a scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in mean PROMIS SF v1.1 - Pain Interference 8a scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in mean Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) sub-scale 2 (pain and discomfort) scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in Floodlight-5 U-Turn Test (5-UTT) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in Floodlight-2 Minute Walk Test (2MWT) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in mean Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) sub-scale 5 (walking) scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in PROMIS SF v1.0 - Sleep Disturbance 4A from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in Numeric Rating Scale-Sleep Disruption (NRS-SD) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Proportion of participants reporting 'very much improved,' 'much improved,' and 'slightly improved' symptoms in the Global Impression of Change (GIC) by subject (SGIC) scores from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Change in Visual Analogue Scale - Quality of Life (VAS-QL) from pre-treatment to post-treatment
Time frame: Baseline; Up to week 18
Proportion of participants who are tolerant of treatment
Time frame: Screening; Up to week 18
Proportion of participants who are tolerant of treatment
Time frame: Screening; Up to week 20
Number of participants with treatment-emergent adverse events while on each treatment
Time frame: Screening; Up to week 20
Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Screening and at each subsequent time-point with reference to the last assessment
Time frame: Screening; Up to week 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. No specific plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Levy, MD, PhD principal investigator
Massachusetts General Hospital
Anastasia Vishnevetsky, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nabiximols in people with NMO Spectrum Disorder and Spasticity, Muscle, run by Michael, Levy M.D.,Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Numeric Rating Scale - Spasticity (NRS-S) scores from pre-treatment to post-treatment (time frame: Baseline; Up to week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.