Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314288

Enrollment

360

Registered

2006-04-13

Start date

2002-07-31

Completion date

2003-07-31

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyskinesia, Parkinson's Disease

Keywords

Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia

Brief summary

The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).

Interventions

DRUGSarizotan HCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or Female * The subject is an out-patient * Age 30 years or above * Dyskinesias present during more than 25% of the waking day * Dyskinesias at least moderately disabling * Written informed consent

Exclusion criteria

* Pregnancy and/or lactation * Participation in another study within the last 30 days * Dementia or other psychiatric illness that prevents provision of informed consent * History of allergic disorders such as asthma * Known hypersensitivity to the study treatment(s) * Known hypersensitivity to ACTH

Countries

Belgium, Bulgaria, Canada, France, Germany, Hungary, Portugal, Romania, South Africa, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026