A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 354 人开始时间: 2005年12月7日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•1. 15-item Geriatric Depression Scale (GDS) = 5
•2. UPDRS Part I Score on Question #3 = 2
•3. Folstein's Mini-Mental State Examination (MMSE) score > 24
•4. Male or female patient with idiopathic PD.
•5. Patients with idiopathic PD, Stage I-III Modified Hoehn and Yahr Scale and optimally controlled PD symptoms in the opinion of the investigator.
•6. Male or female patients aged 30 - 80 years at time of screening visit.
•7. Ability to provide written informed consent in accordance with GCP and local legislation.
•8. Women of childbearing potential must have a negative serum Beta-HCG pregnancy test at the Screening visit unless surgically sterile or last menstruation > 12 months prior to signing IC, or must be using an accepted contraceptive . No exceptions will be made.
•9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
•2. History of suicidal attempts in the last twelve months.
•3. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
•4. History of PD stereotactic brain surgery.
•5. History of active epilepsy (i.e. occurrence of a seizure) within the past year.
•6. Symptomatic orthostatic hypotension prior to randomization.
•7. Malignant melanoma or history of previously treated malignant melanoma.
•8. Patients who have received typical neuroleptics, metoclopramide, selegiline or amphetamine derivatives within the past 6 months.
•9. Patients who have received dopamine agonists within the past 30 days
•10. Electroconvulsive therapy during the 90 days preceding the screening visit (V1).
•11. Patients who are currently lactating.
•12. Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
•13. Any other laboratory assay abnormality and/or clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient according to the investigator

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