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NCT00488839 · ClinicalTrials.gov registry record · Phase 3
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
A Phase 3 study, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT00488839: Completed Phase 3 study, sponsored by Impax Laboratories.
NCT00488839 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 173 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488839, a Phase 3 study, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG IPX056 20 mg
- DRUG IPX056 40 mg
- DRUG Encapsulated Baclofen 20 mg
- DRUG Placebo Baclofen Tablet
- DRUG IPX056 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00488839 record still lists
NCT00488839 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which IPX056 20 mg is the first listed.
NCT00488839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488839 about?
NCT00488839 is a clinical study titled "IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis". 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 spastic...
What is the current status of trial NCT00488839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2007-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00488839?
The interventions under investigation include: IPX056 20 mg (DRUG), IPX056 40 mg (DRUG), Encapsulated Baclofen 20 mg (DRUG), Placebo Baclofen Tablet (DRUG), IPX056 10 mg (DRUG).
Who is sponsoring clinical trial NCT00488839?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00488839's enrollment target sits among peer trials
173 1445th of 2000 higher than 553 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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