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NCT01359566 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis, sponsored by XenoPort.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT01359566 is a Phase 3 study of Multiple Sclerosis that has completed, run by XenoPort. The registered enrollment target is 228 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01359566, a Phase 3 study of Multiple Sclerosis, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 228 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 (61% lower). The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
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.
NCT01359566 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, Arizona.
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.
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).
Who is sponsoring clinical trial NCT01359566?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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