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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 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.

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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.

Conditions Studied

Multiple Sclerosis Spasticity

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

FieldValue
Enrollment Target 353 participants
Start Date 2012-11
Est. Completion 2014-04
Phase Phase 3

Sponsor

RVL Pharmaceuticals

7 total trials

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What the Registry Record Tells You About NCT01743651

The ClinicalTrials.gov registry entry for NCT01743651 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (40% lower). The listed sponsor is RVL Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.