One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity
Public ClinicalTrials.gov record NCT01844232. 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 One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.
Study identification
- NCT ID
- NCT01844232
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Mar 31, 2013
- Primary completion
- Nov 30, 2014
- Completion
- Dec 31, 2014
- Last update posted
- Apr 24, 2022
2013 – 2015
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Osmotica Study Site-154 | Gilbert | Arizona | 85234 | — |
| Osmotica Study Site-158 | Phoenix | Arizona | 85032 | — |
| Osmotica Study Site-165 | Pasadena | California | 91105 | — |
| Osmotica Study Site-164 | Torrance | California | 90505 | — |
| Osomtica Study Site-164 | Torrance | California | 90505 | — |
| Osmotica Study Site-173 | Bradenton | Florida | 34205 | — |
| Osmotica Study Site-178 | Pompano Beach | Florida | 33060 | — |
| Osmotica Study Site-170 | Tampa | Florida | 33606 | — |
| Osmotica Study Site-179 | Northbrook | Illinois | 60096 | — |
| Osmotica Study Site-174 | Lenexa | Kansas | 66214 | — |
| Osmotica Study Site-175 | Ann Arbor | Michigan | 48104 | — |
| Osmotica Study Site-161 | Plainview | New York | 11803 | — |
| Osmotica Study Site-151 | Charlotte | North Carolina | 28203 | — |
| Osmotica Study Site-157 | High Point | North Carolina | 27262 | — |
| Osmotica Study Site-155 | Raleigh | North Carolina | 27607 | — |
| Osmotica Study Site-152 | Wilmington | North Carolina | 28401 | — |
| Osmotica Study Site-156 | Dayton | Ohio | 45417 | — |
| Osmotica Study Site-163 | Philadelphia | Pennsylvania | 19107 | — |
| Osmotica Study Site-162 | Franklin | Tennessee | 37064 | — |
| Osmotica Study Site-171 | San Antonio | Texas | 78229 | — |
| Osmotica Study Site-166 | Vienna | Virginia | 22182 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01844232, 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 24, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01844232 live on ClinicalTrials.gov.