A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Mul… (NCT05179577) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
442 participantsStarted 2027-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
* In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
* Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
* 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 depres…
What they're measuring
1
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)