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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105508
First Posted: March 16, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
EMD Serono
  Purpose
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).

Condition Intervention Phase
Parkinson's Disease Dyskinesia Drug: Sarizotan HC1 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Enrollment: 611
Study Start Date: September 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105508


  Show 31 Study Locations
Sponsors and Collaborators
EMD Serono
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00105508     History of Changes
Other Study ID Numbers: EMR 62225-018
First Submitted: March 15, 2005
First Posted: March 16, 2005
Last Update Posted: October 12, 2017
Last Verified: January 2017

Keywords provided by EMD Serono:
Parkinson's Disease
Dyskinesia
Dyskinesia associated with dopaminergic treatment

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms