Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
NCT ID: NCT00105521
Last Updated: 2018-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
398 participants
INTERVENTIONAL
2004-09-30
2006-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
NCT00105508
Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
NCT00314288
Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia
NCT00310661
DNS-7801 vs. Placebo in Parkinson's Disease
NCT03306329
A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
NCT01603069
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Placebo
Placebo matching to sarizotan will be administered twice daily.
Sarizotan 2 milligrams per day (mg/day)
Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Sarizotan
Sarizotan will be administered twice daily.
Sarizotan 4 mg/day
Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Sarizotan
Sarizotan will be administered twice daily.
Sarizotan 10 mg/day
Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Sarizotan
Sarizotan will be administered twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sarizotan
Sarizotan will be administered twice daily.
Placebo
Placebo matching to sarizotan will be administered twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The participant presents with a diagnosis of idiopathic Parkinson's disease
* Prior therapy with all registered Parkinsonian medication is allowed
Exclusion Criteria
* The participant is participating in another clinical study or has done so within the past 30 days
* The participant has received neurosurgical intervention related to Parkinson's disease
* The participant has relevant renal impairment
* The participant has relevant hepatic impairment
* The participant is suffering from any dementia or psychiatric illness
* The participant has a history of allergic asthma
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EMD Serono
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fayetteville, Arkansas, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Ocala, Florida, United States
Port Charlotte, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Golden Valley, Minnesota, United States
Omaha, Nebraska, United States
Albany, New York, United States
New York, New York, United States
Syracuse, New York, United States
Toledo, Ohio, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Upland, Pennsylvania, United States
Dallas, Texas, United States
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Goetz CG, Damier P, Hicking C, Laska E, Muller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. doi: 10.1002/mds.21226.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EMR 62225-019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.