Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
NCT01743651 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01743651
The ClinicalTrials.gov registry entry for NCT01743651 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RVL Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01743651 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, New York, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01743651?
The interventions under investigation include: Placebo (DRUG), arbaclofen (DRUG), baclofen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01743651?
This trial is sponsored by RVL Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.