A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (OS440-3004)
A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis
Sponsor: Osmotica Pharmaceutical US LLC
A PHASE3 clinical study on Multiple Sclerosis and Spasticity, Muscle, this trial is completed. The trial is conducted by Osmotica Pharmaceutical US LLC and has accumulated 12 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
12 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Sep 2022 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2022 — Sep 2022 [monthly]
Completed PHASE3
▶ Show 7 earlier versions
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Apr 2022 — Jun 2022 [monthly]
Completed PHASE3
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Jan 2021 — Apr 2022 [monthly]
Completed PHASE3
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Oct 2019 — Jan 2021 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Feb 2019 — Oct 2019 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jun 2018 — Feb 2019 [monthly]
Recruiting PHASE3
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Mar 2018 — Jun 2018 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Oct 2017 — Mar 2018 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Osmotica Pharmaceutical US LLC
- RVL Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Banja Luka, Bosnia and Herzegovina , Belgrade, Serbia , Chisinau, Moldova , Grodno, Belarus , Katowice, Poland , Kragujevac, Serbia , Lodz, Poland , Lublin, Poland , Minsk, Belarus , Mostar, Bosnia and Herzegovina and 11 more locations