IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
Public ClinicalTrials.gov record NCT00488839. 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 Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.
Study identification
- NCT ID
- NCT00488839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 173 participants
Conditions and interventions
Conditions
Interventions
- IPX056 20 mg Drug
- IPX056 40 mg Drug
- Encapsulated Baclofen 20 mg Drug
- Placebo Baclofen Tablet Drug
- IPX056 10 mg Drug
- IPX056 30 mg Drug
- IPX056 35 mg Drug
- Placebo IPX056 20 mg Drug
- Placebo IPX056 40 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 2007 (Type not available)
- Primary completion
- May 2008 (Actual)
- Completion
- May 2008 (Actual)
- Last update posted
- Nov 6, 2019
2007 – 2008
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwest NeuroSpecialists | Tucson | Arizona | 85741 | — |
| OrthoArkansas, P. A. | Little Rock | Arkansas | 72201 | — |
| OrthoArkansas, P.A. | Little Rock | Arkansas | 72201 | — |
| Patricia Fodor | Colorado Springs | Colorado | 80919 | — |
| Sunrise Clinical Research | Hollywood | Florida | 33021 | — |
| Meridien Research | Tampa | Florida | 33606 | — |
| MS Center of Atlanta | Atlanta | Georgia | 30327 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Elkhardt Clinic | Elkhart | Indiana | 46514 | — |
| MidAmerica Neuroscience Institute | Lenexa | Kansas | 66214 | — |
| Springfield Neurology | Springfield | Massachusetts | 01104 | — |
| General Clinical Research Center 7A | Ann Arbor | Michigan | 48109 | — |
| Medex Healthcare Research, Inc. | Saint Louis | Michigan | 63117 | — |
| Northern Michigan Neurology | Traverse City | Michigan | 49684 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Crozer Chester Medical Center | Upland | Pennsylvania | 19013 | — |
| Bhupesh Dihenia | Lubbock | Texas | 79410 | — |
| Integra Clinical Research | San Antonio | Texas | 78229 | — |
| Neurological Research Center | Bennington | Vermont | 05201 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00488839, 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 Nov 6, 2019 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00488839 live on ClinicalTrials.gov.