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NCT01743651 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis and Spasticity, sponsored by RVL Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT01743651: Completed Phase 3 study of Multiple Sclerosis and Spasticity, sponsored by RVL Pharmaceuticals.
NCT01743651 is a Phase 3 study of Multiple Sclerosis and Spasticity that has completed, run by RVL Pharmaceuticals. The registered enrollment target is 353 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01743651, a Phase 3 study of Multiple Sclerosis and Spasticity, has completed, sponsored by RVL Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.
Primary Outcome
Change from baseline through end of treatment in the pre-dose, morning TNmAS of the most affected limb. The most affected limb is determined at baseline using the sum of scores for three major motor groups. High scores indicate more severe spasticity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG arbaclofen
- DRUG baclofen
Study Locations (20)
Florida
- Osmotica Study Site-110 - Bradenton
- Osmotica Study Site-142 - Maitland
- Osmotica Study Site-119 - Ormond Beach
- Osmotica Study Site-120 - Pompano Beach
- Osmotica Study Site-109 - Tampa
New York
- Osmotica Study Site-115 - Johnson City
- Osmotica Study Site-113 - New York
- Osmotica Study Site-141 - New York
- Osmotica Study Site-125 - New York
Alabama
- Osmotica Study Site-138 - Cullman
California
- Osmotica Site-143 - Long Beach
Colorado
- Osmotica Study Site-123 - Aurora
Illinois
- Osmotica Study Site-126 - Northbrook
Indiana
- Osmotica Study Site-108 - Fort Wayne
Kansas
- Osmotica Study Site-116 - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01743651 record still lists
NCT01743651 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01743651 names 20 study sites across 13 states, led by Florida, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT01743651 about?
NCT01743651 is a clinical study titled "Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis". This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and ...
What is the current status of trial NCT01743651?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2012-11. Estimated completion is 2014-04.
What conditions does trial NCT01743651 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Spasticity.
What interventions are being tested in trial NCT01743651?
The interventions under investigation include: Placebo (DRUG), arbaclofen (DRUG), baclofen (DRUG).
Who is sponsoring clinical trial NCT01743651?
This trial is sponsored by RVL Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01743651 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01743651's enrollment target sits among peer trials
353 52nd of 315 higher than 264 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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