A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
- Conditions
- Spasticity
- Registration Number
- NCT05179577
- Lead Sponsor
- RVL Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Subjects 18 to 65 years of age, inclusive<br><br> - An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR<br> or SP course) that manifests a documented history of spasticity for at least 6<br> months prior to screening<br><br> - Spasticity due to MS as shown by a TNmAS-MAL score = 2<br><br> - Expanded Disability Status Scale (EDSS) score greater than or equal to (=) 3.0 and<br> less than or equal to (=) 7.0<br><br> - Absence of infections, peripheral vascular disease, painful contractures, advanced<br> arthritis, or other conditions that hinder evaluation of joint movement<br><br> - Use of a medically highly effective form of birth control (see Section 7.8) during<br> the study and for 3 months thereafter for women of child-bearing potential<br> (including female subjects and female partners of non-sterile male subjects)<br><br> - Willing to sign the informed consent form (ICF)<br><br>Exclusion Criteria:<br><br> - Any concomitant disease or disorder that has symptoms of spasticity or that may<br> influence the subject's level of spasticity<br><br> - In the opinion of the investigator, the patient is unable to rate their level of<br> spasticity or distinguish it from other MS symptoms<br><br> - Concomitant use of medications that would potentially interfere with the actions of<br> the study medication or outcome variables<br><br> - Pregnancy, lactation, or planned pregnancy during the course of the study and for 3<br> months after the final study visit<br><br> - Current significant cognitive deficit, severe or untreated anxiety, severe or<br> untreated depression<br><br> - Current malignancy or history of malignancy that has not been in remission for more<br> than 5 years, except effectively treated basal cell skin carcinoma<br><br> - Any other significant disease, disorder, or significant laboratory finding which, in<br> the opinion of the investigator, puts the subject at risk because of participation,<br> influences the result of the study, or affects the subject's ability to participate
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL);Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period
- Secondary Outcome Measures
Name Time Method Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL);Clinician's global impression of change (CGIC) for Maintenance Treatment Period;Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period;Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period