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Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249-7340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Idiopathic Parkinson's disease

Modified Hoehn and Yahr Scale Stages I through III

Age greater than or equal to 30 years old

Patients or their partners must use adequate contraceptive methods

Patients who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures and do not plan on traveling extensively
during the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or
degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days
prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition

NCT00058838
Pfizer
Completed
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.
The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Parkinson Disease
Drug: sumanirole
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
854
September 2004
Not Provided

Inclusion Criteria:

Idiopathic Parkinson's disease < 7 years duration

Modified Hoehn and Yahr Scale Stages I through III

Age greater than or equal to 30 years old

Patients or their partners must use adequate contraceptive methods

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

Exclusion Criteria:

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition

Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Colombia,   France,   Germany,   Greece,   Italy,   Mexico,   Peru,   Puerto Rico,   Spain,   United States
 
 
NCT00058838
DA2APD-0075-031
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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