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NCT00105508 · ClinicalTrials.gov registry record · Phase 3
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
A Phase 3 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
NCT00105508: Completed Phase 3 study, sponsored by EMD Serono.
NCT00105508 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 506 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00105508, a Phase 3 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
Primary Outcome
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, re
Interventions
- DRUG Placebo
- DRUG Sarizotan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2004-09-30 |
| Est. Completion | 2006-02-28 |
| Phase | Phase 3 |
What the finished NCT00105508 record still lists
NCT00105508 is an interventional study that assigns participants to a tested intervention. The registered 506 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 (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00105508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00105508 about?
NCT00105508 is a clinical study titled "Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia". The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
What is the current status of trial NCT00105508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2004-09-30. Estimated completion is 2006-02-28.
What interventions are being tested in trial NCT00105508?
The interventions under investigation include: Placebo (DRUG), Sarizotan (DRUG).
Who is sponsoring clinical trial NCT00105508?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00105508's enrollment target sits among peer trials
506 741st of 2000 higher than 1,259 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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