Completed PHASE3 INTERVENTIONAL 3-arm NCT01743651

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

Sponsor: Osmotica Pharmaceutical US LLC

Conditions Multiple Sclerosis Spasticity

Interventions Placebo arbaclofen baclofen

Updated 10 times since 2017 Last updated: Apr 21, 2022 Started: Nov 30, 2012 Primary completion: Apr 30, 2014 Completion: Apr 30, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Multiple Sclerosis and Spasticity and is currently completed. Osmotica Pharmaceutical US LLC leads this study, which shows 10 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
May 2022 — Jul 2024 [monthly]

Completed PHASE3
Apr 2022 — May 2022 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Jun 2021 — Apr 2022 [monthly]

Completed PHASE3
Jan 2021 — Jun 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Osmotica Pharmaceutical US LLC
RVL Pharmaceuticals, Inc.

Data source: RVL Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Aurora, United States , Baltimore, United States , Bradenton, United States , Charlotte, United States , Chernihiv, Ukraine , Cincinnati, United States , Cullman, United States , Dnipropetrovsk, Ukraine , Donetsk, Ukraine and 27 more locations