PER-024-03已完成未知
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.
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,0 个研究点目标入组 0 人开始时间: 2003年3月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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