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NCT00105521 · ClinicalTrials.gov registry record · Phase 3

Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

A Phase 3 study, sponsored by EMD Serono.

Completed
Registry status
Phase 3
Development phase
398
Enrollment target

NCT00105521: Completed Phase 3 study, sponsored by EMD Serono.

NCT00105521 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 398 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00105521, a Phase 3 study, has completed, sponsored by EMD Serono.

COMPLETED
Registry status
Phase 3
Development phase
398 participants
Enrollment target

Study Summary

The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.

Primary Outcome

On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.

Interventions

  • DRUG Placebo
  • DRUG Sarizotan

Trial Details

FieldValue
Enrollment Target 398 participants
Start Date 2004-09-30
Est. Completion 2006-03-31
Phase Phase 3
EMD Serono

71 total trials

What the finished NCT00105521 record still lists

NCT00105521 is an interventional study that assigns participants to a tested intervention. The registered 398 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 (48% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00105521 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00105521 about?

NCT00105521 is a clinical study titled "Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia". The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.

What is the current status of trial NCT00105521?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 398 participants. The study started on 2004-09-30. Estimated completion is 2006-03-31.

What interventions are being tested in trial NCT00105521?

The interventions under investigation include: Placebo (DRUG), Sarizotan (DRUG).

Who is sponsoring clinical trial NCT00105521?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00105521's enrollment target sits among peer trials

398 963rd of 2000 higher than 1,037 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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Source: ClinicalTrials.gov NCT00105521, the US trial registry maintained by the National Library of Medicine. NCT00105521 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.