Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 25, 2007

Last Updated Date

April 24, 2009

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

The primary efficacy endpoint of the trial is the change from baseline to end of the maintenance period in UPDRS parts II+III score. [ Time Frame: 33 weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00479401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Responder rate for Clinical Global Impression of Improvement Responder rate for Patient Global Impression of Improvement UPDRS I, II and III scores separately [ Time Frame: 33 weeks ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Official Title ^†

A Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-Week Maintenance Phase in Patients With Early Parkinsons Disease (PD).

Brief Summary

The objectives of this trial conducted in early PD patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for UPDRS Parts II and III combined), safety, and tolerability of Pramipexole ER (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.

In addition, the efficacy of Pramipexole IR will be compared to placebo, for assay sensitivity

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Parkinson Disease

Intervention ^†

Drug: Pramipexol Extended Release
Drug: Pramipexol Immediate Release
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

539

Completion Date

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrolment (screening visit, V1) according to the investigators judgement.

Exclusion Criteria:

Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
Any psychiatric disorder according to DSM-IV
History of psychosis
Clinically significant electrocardiogram (ECG) abnormalities at screening visit
Clinically significant hypotension
Malignant melanoma or history of previously treated malignant melanoma
Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
Pregnancy
Sexually active female of childbearing potential not using a medically approved method of birth control
Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN
Patients with a creatinine clearance < 50 mL/min
Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
Total cumulative duration of prior exposure to Levodopa of more than 3 months.
Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Flunarizine within 3 months prior to baseline visit
Known hypersensitivity to Pramipexole or its excipients
Drug abuse (including alcohol), according to Investigators judgement, within 2 years prior to screening.
Participation in other investigational drug studies or use of other investigational drugs within one month or five times the half-life of the investigational drug

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Austria, Czech Republic, Finland, Germany, Hungary, India, Japan, Malaysia, Russian Federation, Slovakia, Taiwan, Ukraine

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00479401

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Secondary IDs ^††

Eudract No 2007-000073-39

Study Sponsor ^†

Boehringer Ingelheim Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.