Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

NCT ID: NCT00105508

Last Updated: 2018-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Dyskinesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sarizotan

Group Type EXPERIMENTAL

Sarizotan

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sarizotan

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The subject is an out-patient.
* The subject presents with a diagnosis of idiopathic Parkinson's disease.
* Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria

* (For female subjects) The subject is pregnant or lactating.
* The subject is participating in another clinical study or has done so within the past 30 days.
* The subject has received neurosurgical intervention related to PD.
* The subject has relevant renal impairment.
* The subject has relevant hepatic impairment.
* The subject is suffering from any dementia or psychiatric illness.
* The subject has a history of allergic asthma.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham, Alabama, United States

Site Status

Huntsville, Alabama, United States

Site Status

La Jolla, California, United States

Site Status

Oxnard, California, United States

Site Status

Sacramento, California, United States

Site Status

Englewood, Colorado, United States

Site Status

Danbury, Connecticut, United States

Site Status

Farmington, Connecticut, United States

Site Status

Jacksonville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Maitland, Florida, United States

Site Status

St. Petersburg, Florida, United States

Site Status

Decatur, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Springfield, Illinois, United States

Site Status

Des Moines, Iowa, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Scarborough, Maine, United States

Site Status

Boston, Massachusetts, United States

Site Status

Southfield, Michigan, United States

Site Status

Edison, New Jersey, United States

Site Status

New Hyde Park, New York, United States

Site Status

New Hyde Park, New York, United States

Site Status

New York, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Brentwood, Tennessee, United States

Site Status

South Ogden, Utah, United States

Site Status

Spokane, Washington, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.

Reference Type RESULT
PMID: 18175337 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EMR 62225-018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

DNS-7801 vs. Placebo in Parkinson's Disease
NCT03306329 TERMINATED PHASE2
Aim to Reduce Movements in Tardive Dyskinesia
NCT02195700 COMPLETED PHASE2/PHASE3