One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity
A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity
Sponsor: Osmotica Pharmaceutical US LLC
This PHASE3 trial investigates Multiple Sclerosis and Spasticity and is currently completed. Osmotica Pharmaceutical US LLC leads this study, which shows 11 recorded versions since 2013 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
11 versions recorded-
Dec 2025 — Present [monthly]
Completed PHASE3
-
Sep 2025 — Dec 2025 [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
May 2022 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 6 earlier versions
-
Apr 2022 — May 2022 [monthly]
Completed PHASE3
-
Jan 2021 — Apr 2022 [monthly]
Completed PHASE3
-
Feb 2020 — Jan 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Feb 2020 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Apr 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
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 .