A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Launched by RVL PHARMACEUTICALS, INC. · Dec 16, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called arbaclofen ER, which is taken in tablet form, to see how well it helps reduce spasticity in people with Multiple Sclerosis (MS). Spasticity is a condition that causes stiffness and tightness in the muscles, making it difficult to move around. The study will compare arbaclofen ER to a placebo (a harmless pill with no active medication) to find out if it is effective and safe for patients.

To participate in this study, individuals need to be between 18 and 65 years old and have a confirmed diagnosis of MS, along with a history of spasticity for at least six months. Eligible participants must also have a specific level of disability and be willing to use effective birth control during the study. People with certain medical conditions or those taking medications that could interfere with the study will not be eligible. If you join the study, you can expect to take the medication or placebo for a set period and attend regular check-ups to monitor your progress. This research aims to find better treatments for spasticity in MS, potentially improving quality of life for many patients.

Gender

ALL

Eligibility criteria

• 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 depression
• • Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma
• • 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