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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Early Parkinson Disease (Early PD)

Treatments

Drug: Placebo

Drug: Pramipexol Extended Release

Drug: Pramipexol Immediate Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00479401

248.524

Eudract No 2007-000073-39

Details and patient eligibility

About

The objectives of this trial conducted in early Parkinson's Disease (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 the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (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 Immediate Release (IR) will be compared to placebo, for assay sensitivity

Enrollment

539 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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 enrollment (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 Diagnostic and Statistical Manual of Mental Disorders 4th (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 Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (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