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

Phase 3

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00274131
• Lead Sponsor: Boehringer Ingelheim

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):

Study Timeline

• Study Start: 1998-12
• Study Completion: 2004-02
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score

Secondary Outcome Measures

Name	Time	Method
UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy