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

NCT05179577 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: OS440-3006
• Study Type: interventional
• Target: 442
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (2)

• Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)

  The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

• Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period

  Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

Secondary Outcomes (4)

• Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

• Clinician's global impression of change (CGIC) for Maintenance Treatment Period

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

• Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

• Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period

  Maintenance Treatment Period: Visit 5 (day 77), Visit 6 (day 105), and Visit 7 (day 133)

Study Arms (2)

Arbaclofen Extended-Release

ACTIVE COMPARATOR

Extended-release oral tablet, twice daily dosing (80 mg/day)

Drug: Arbaclofen

Placebo

PLACEBO COMPARATOR

Extended-release oral tablet, twice daily dosing

Drug: Placebo

Interventions

Arbaclofen DRUG

Arbaclofen Extended Release Tablets

Also known as: OS440, AERT

Arbaclofen Extended-Release

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RVL Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Muscle Spasticity

Interventions

arbaclofen placarbil

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tina deVries, PhD

  RVL Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Joann Stavole

CONTACT

9088091343; jstavole@rvlpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: January 5, 2022
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share