Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)

(1) Patients meeting all of the following inclusion criteria

1. Patients of at least 20 years of age

2. In- or outpatients of either sex.

3. Patients in any stage on the modified Hoehn and Yahr severity scale

Exclusion Criteria:

• Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.

• Patients with subjective symptoms derived from orthostatic hypotension.

• Patients with hypotension (systolic blood pressure <100 mmHg)

• Patients with concomitant illness such as severe cardiac, renal, and hepatic disease

• Patients with a current or past history of epilepsy

• Pregnant, possibly pregnant, or lactating women

• Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.

• Patients who judged incompetent to give consent

• Others judged by the investigator or co-investigator to be ineligible as subjects.