Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00036205

Purpose

The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.

Condition	Intervention	Phase
Parkinson Disease	Drug: sumanirole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Sumanirole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.

Secondary Outcome Measures:

Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson’s Disease Rating Scale).
Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Part III will be used to evaluate motor function.
Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

Estimated Enrollment:	984
Study Start Date:	August 2000
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic Parkinson's disease
Modified Hoehn and Yahr Scale Stages 1-4
Age over 30 years
Previous participation in prior sumanirole studies

Exclusion Criteria:

Use of dopamine agonist medications and other medications in defined timeframe
Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
Dementia
History of active epilepsy within the past year
Significant liver disease with defined laboratory criteria
Significant renal disease with defined laboratory criteria
Certain cardiac conditions
Electroconvulsive therapy in the previous 90 days
Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
Positive pregnancy test at Screen
Unwillingness to use adequate contraceptive methods
Lactating women
History of stereotaxic brain surgery
Malignant melanoma or history of treated melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036205

Show 115 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	M27600011
Study First Received:	May 8, 2002
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00036205 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 22, 2009