Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease

NCT02231905 | Completed Phase 4

• 1 other identifier: 248.544
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients who prematurely discontinued due to adverse event

  up to 12 weeks

Secondary Outcomes (8)

• Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)

  up to 12 weeks

• Change of the sum of UPDRS Part III (motor examination)

  up to 12 weeks

• Change of Modified Hoehn & Yahr scale

  up to 12 weeks

• Change of Clinical global impression (CGI) of efficacy

  up to 12 weeks

• Number of patients with abnormal changes in laboratory parameters

  up to 12 weeks

Study Arms (1)

BI-Sifrol®

EXPERIMENTAL

Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.

Drug: BI-Sifrol®

Interventions

BI-Sifrol® DRUG

BI-Sifrol®

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
• Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
• Male or female patients aged 20 and over
• In or out-patients
• Patient's severity characterized as Stage 1 - 5 by Modified Hoehn \& Yahr scale
• Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law

You may not qualify if:

• History of hypersensitivity of pramipexole
• Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
• Subjective symptom derived from orthostatic hypotension
• Hypotension (systolic blood pressure; 100 mmHg or less)
• Complication such as clinically significant cardiac, renal and hepatic diseases
• Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities
• Pregnant, possibly pregnant or female in lactation
• Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study
• Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 4, 2014
• Study Start: January 1, 2004
• Primary Completion: November 1, 2004
• Last Updated: September 4, 2014

Record last verified: 2014-09