NCT05179577Not yet recruitingPhase 3
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 442 (estimated)
- First submitted
- 12 Nov 2021
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT05179577
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 442
- From 1 Jan 2027 to the primary completion date, 31 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
- Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
Other illness
- Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
Lab values
- Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate
Other
- In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
- Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
- Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
Who the study is looking for
- Subjects 18 to 65 years of age, inclusive
- An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
- Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
- Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
- Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement
- Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects)
- Willing to sign the informed consent form (ICF)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.