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

NCT ID: NCT00274131

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2004-02-29

Brief Summary

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

Detailed Description

The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).

The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).

Study Hypothesis:

Comparison(s):

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pramipexole 0.125 mg tablets

Intervention Type: DRUG

Pramipexole 0.5 mg tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Nippon Boehringer Ingelheim Co., Ltd.

Other Identifiers

248.506

Identifier Type: -

Identifier Source: org_study_id