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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00058838




Registration number
NCT00058838
Ethics application status
Date submitted
14/04/2003
Date registered
15/04/2003
Date last updated
7/06/2006

Titles & IDs
Public title
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
Scientific title
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.
Secondary ID [1] 0 0
DA2APD-0075-031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sumanirole

Treatment: Drugs: sumanirole
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Sydney
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2067 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Connecticut
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Capital Federal
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Buenos Aires
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Linz
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Wien
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Edegem
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Straubing
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Wiesbaden
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Attiki
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Macedonia
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LU
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Firenze
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Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00058838
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00058838