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COMPLETED Phase 3

Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

NCT01359566 · View on ClinicalTrials.gov ↗

Study Summary

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Arbaclofen placarbil 15 mg BID
  • DRUG Arbaclofen placarbil 30 mg BID
  • DRUG Arbaclofen placarbil 45 mg BID

Study Locations (20)

Florida

  • XenoPort Clinical Site — Port Charlotte
  • XenoPort Clinical Site — Sarasota
  • XenoPort Clinical Site — St. Petersburg
  • XenoPort Clinical Site — Tampa

New York

  • XenoPort Clinical Site — Albany
  • XenoPort Clinical Site — Patchogue
  • XenoPort Clinical Site — Plainview

Arizona

  • XenoPort Clinical Site — Phoenix
  • XenoPort Clinical Site — Tucson

California

  • XenoPort Clinical Site — Berkeley
  • XenoPort Clinical Site — San Diego

Michigan

  • XenoPort Clinical Site — Bingham Farms
  • XenoPort Clinical Site — Detroit

Colorado

  • XenoPort Clinical Site — Denver

Illinois

  • XenoPort Clinical Site — Lake Barrington

Indiana

  • XenoPort Clinical Site — Indianapolis

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2011-05
Est. Completion 2013-02
Phase Phase 3

Sponsor

XenoPort

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01359566

The ClinicalTrials.gov registry entry for NCT01359566 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 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 4 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: NCT01359566 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, Arizona. 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 NCT01359566 about?

NCT01359566 is a clinical study titled "Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis". To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).

What is the current status of trial NCT01359566?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2011-05. Estimated completion is 2013-02.

What conditions does trial NCT01359566 study?

This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01359566?

The interventions under investigation include: Placebo (DRUG), Arbaclofen placarbil 15 mg BID (DRUG), Arbaclofen placarbil 30 mg BID (DRUG), Arbaclofen placarbil 45 mg BID (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01359566?

This trial is sponsored by XenoPort, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01359566 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial