Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
Public ClinicalTrials.gov record NCT01743651. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01743651
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 353 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2012 (Type not available)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Apr 25, 2022
2012 – 2014
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Osmotica Study Site-138 | Cullman | Alabama | 35058 | — |
| Osmotica Site-143 | Long Beach | California | 92845 | — |
| Osmotica Study Site-123 | Aurora | Colorado | 80045 | — |
| Osmotica Study Site-110 | Bradenton | Florida | 34205 | — |
| Osmotica Study Site-142 | Maitland | Florida | 32751 | — |
| Osmotica Study Site-119 | Ormond Beach | Florida | 32174 | — |
| Osmotica Study Site-120 | Pompano Beach | Florida | 33060 | — |
| Osmotica Study Site-109 | Tampa | Florida | 33606 | — |
| Osmotica Study Site-126 | Northbrook | Illinois | 60096 | — |
| Osmotica Study Site-108 | Fort Wayne | Indiana | 46805 | — |
| Osmotica Study Site-116 | Lenexa | Kansas | 66214 | — |
| Osmotica Study Site-124 | Baltimore | Maryland | 21201 | — |
| Osmotica Study Site-136 | Springfield | Massachusetts | 01104 | — |
| Osmotica Study Site-101 | Ann Arbor | Michigan | 48104 | — |
| Osmotica Study Site-115 | Johnson City | New York | 13790 | — |
| Osmotica Study Site-113 | New York | New York | 10016 | — |
| Osmotica Study Site-141 | New York | New York | 10019 | — |
| Osmotica Study Site-125 | New York | New York | 10029 | — |
| Osmotica Study Site-106 | Charlotte | North Carolina | 28204 | — |
| Osmotica Study Site-131 | Cincinnati | Ohio | 45219 | — |
| Osmotica Study Site-127 | Pittsburgh | Pennsylvania | 15212 | — |
| Osmotica Study Site-112 | San Antonio | Texas | 78229 | — |
| Osmotica Study Site-133 | Salt Lake City | Utah | 84103 | — |
| Osmotica Study Site-129 | Seattle | Washington | 98122 | — |
| Osmotica SIte-144 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01743651, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01743651 live on ClinicalTrials.gov.