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NCT01844232 · ClinicalTrials.gov registry record · Phase 3
One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity
A Phase 3 study, sponsored by RVL Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01844232: Completed Phase 3 study, sponsored by RVL Pharmaceuticals.
NCT01844232 is a Phase 3 study that has completed, run by RVL Pharmaceuticals. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844232, a Phase 3 study, has completed, sponsored by RVL Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.
Primary Outcome
Determination of incidence and severity of Adverse Events (AEs), discontinuations due to AEs and discontinuations due to failure of AERT to alleviate spasticity
Interventions
- DRUG arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01844232 record still lists
NCT01844232 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which arbaclofen is the first listed.
NCT01844232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01844232 about?
NCT01844232 is a clinical study titled "One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity". Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbac...
What is the current status of trial NCT01844232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01844232?
The interventions under investigation include: arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01844232?
This trial is sponsored by RVL Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01844232's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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