CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 506 enrolled
Drug / intervention
Sarizotan +1 moredrug
Likely dose
Sarizotan 1 mg orally twice dailyAI-extracted
Key inclusion· 3
  • ✓Outpatient status
  • ✓Diagnosis of idiopathic Parkinson's disease
  • ✓Prior therapy with all registered Parkinsonian medication is allowed
Key exclusion· 7
  • ✕Pregnancy or lactation
  • ✕Participation in another clinical study within the past 30 days
  • ✕Prior neurosurgical intervention related to PD
  • ✕Relevant renal impairment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00105508
NCT00105508Phase 3Completed
CompareCT.gov

A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

EMD Serono·interventional·Posted Mar 16, 2005·Updated Jul 26, 2018

In Brief

A Phase 3 clinical trial evaluating Sarizotan and Placebo for Parkinson's Disease and Dyskinesia. Completed, enrolled 506 participants across 31 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease, Dyskinesia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2005
Enrollment StartSep 30, 2004
Primary CompletionFeb 28, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 21.3 years ago

Interventions

Sarizotandrug

Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.

Placebodrug

Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.