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NCT00557973 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT00557973: Completed Phase 2 study, sponsored by XenoPort.
NCT00557973 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00557973, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury
Primary Outcome
Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment
Interventions
- DRUG Placebo
- DRUG XP19986 SR1, 10 mg BID
- DRUG XP19986 SR1, 20 mg BID
- DRUG XP19986 SR1, 30 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00557973 record still lists
NCT00557973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00557973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00557973 about?
NCT00557973 is a clinical study titled "A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury". The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury
What is the current status of trial NCT00557973?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00557973?
The interventions under investigation include: Placebo (DRUG), XP19986 SR1, 10 mg BID (DRUG), XP19986 SR1, 20 mg BID (DRUG), XP19986 SR1, 30 mg BID (DRUG).
Who is sponsoring clinical trial NCT00557973?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00557973's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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