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

NCT00036218

Last updated date
Study Location
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
Official Title  ICMJE A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
Brief Summary The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: sumanirole
  • Drug: ropinirole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 6, 2006)
600
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE April 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00036218
Other Study ID Numbers  ICMJE 666E-CNS-0075-021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP