PHASE III STUDY, MULTICENTRIC RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, RESPONSE TO FIXED DOSE, THAT COMPARES THE EFFICACY AND SAFETY OF SUMANIROLE VERSUS PLACEBO IN PATIENTS WITH EARLY PARKINSON DISEASE.
- Conditions
- -G20 Parkinson´s diseaseParkinson´s diseaseG20
- Registration Number
- PER-024-03
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Idiopathic Parkinson´s disease <7 years.
2. Stages I, II or III of the Modified Hoehn and Yahr Scale.
3. Age> 30 years.
4. Patients or their partners should use adequate contraception.
5. Evidence of a personally signed informed consent document and
dated indicating that the patient (or a legally acceptable representative) has been
informed of all the aspects related to the study.
6. Patients who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures and who do not plan to travel extensively during the study.
1. Parkinson´s disease syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
2. Have received L-dopa for an accumulated interval of> 1 year in the previous 2 years.
3. Have received L-dopa, dopamine agonist drugs (eg pramipexole), catacol-o-methyl transferase (COMT) inhibitors, (eg entacapon) within 30 days prior to basal, (allowed: selegiline, therapy anticholinergic or with amantidine at a stable dose for 30 days before the study and during the study).
4. History of stereotactic brain surgery.
5. Hepatitis B (superlicity antigen) or hepatitis (J (antibody) positive.
6. Surgery within 180 days of the baseline visit, which, in the opinion of the investigator, would have a negative impact on the patient´s participation in the study.
7. Dementia (score on the Mini-Mental Exam <24).
8. History of active epilepsy (ie, presence of a seizure) during the last year.
9. Third-degree AV block or sick node syndrome.
10. Congestive heart failure classified as Class N or IV by the New York Heart Association.
11. Myocardial infarction in the 6 months prior to baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Unified Parkinson s Disease Rating Scale<br>Measure:Change from baseline in UPDRS (Unified Parkinson s Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo<br>Timepoints:31 week<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:quality of life<br><br>Measure:To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo.<br>Timepoints:31 week<br>