A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease.

Boehringer Ingelheim7 sites in 1 country208 target enrollmentJuly 2003

ConditionsParkinson Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 208
Locations: 7
Primary Endpoint: Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial)

Detailed Description

The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinson's disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators (phase III comparative trial). For efficacy evaluation, two primary endpoints were chosen: * Totalled score according to Part III of UPDRS (motor examination) * Totalled score according to Part II of UPDRS (activities of daily living) The safety profile of the study drug was evaluated by physical examination, blood pressure, Electrocardiogram, Laboratory tests, AEs and SAEs. Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups, i.e., Pramipexole tablets or Bromocriptine tablets. Patients were administered the study drug according to the dosing schedule. The treatment period lasted maximal 12 weeks (ascending dose interval: up to 8 weeks, maintenance dose interval: 4 weeks or longer). In addition, a descending dose interval was 1-4 weeks. Each patient received 7 visits except the patients drops or withdrawals: visit 1: screening visit 2: randomization and baseline visit 3-6: ascending dose interval visit 7: Maintenance dose interval Study Hypothesis: Primary variables are both total of UPDRS (Unified Parkinson's Disease Rating Scale) part III items and of UPDRS part II items in change from baseline. The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margin(=delta; the clinically largest difference judged as clinically acceptable) with 90% power, one sided for the above two primary variables at the error probability of 2.5% each. The equivalency margin for the primary variables (total of UPDRS Part III, and of UPDRS Part II) can be determined as 2.0 and 1.0 respectively referring to the results of oversea pivotal study of Pramipexole (BI Trial No. 248.326; U96-0232) and judged by the study investigator. Comparison(s): The primary endpoint of the study was the change of totalled score according to Part III of UPDRS (motor examination) and totalled score according to Part II of UPDRS (activities of daily living) after 12 weeks treatment of the study drug.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

August 2004

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Patients aged 30-80 years
•Patients with idiopathic Parkinson's disease corresponding to stages II-IV according to the classification of Hoehn and Yahr during an "on" period, and/or patients in whom the individual optimized dosage of levodopa (and decarboxylase inhibitor) causes motor fluctuations characterized as end-of-dose phenomena or "wearing-off" effects for at least 30 days prior to initial administration of study medication and whose daily total "off" time is at least 2 hours and no more than 6 hours during waking time.
•Patients able to keep an accurate patient diary of the times of "on"- and "off"-periods during waking hours. Family members, guardians or nursing personnel may assist the patient.
•Informed Consent (consent in writing)

Exclusion Criteria

•Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders , encephalitis, or degenerative disease.
•Dementia that could impair compliance with medication, impair maintenance of accurate patient diaries, and/or preclude the signing of informed consent.
•History of psychosis except that which was elicited by treatment with levodopa or dopamine agonists unless the patient remains psychotic and in the opinion of the investigator would be unable to participate in the study.
•History of active epilepsy within the last two years prior to Visit
•Patients with second or third degree AV block or sick sinus syndrome.
•Patients with resting heart rate below 50 beats per minute.
•Patients with congestive heart failure classified as functional Class III or IV by the New York Heart Association.
•Patients with myocardial infarction within six months of randomization.
•Patients with other clinical significant heart conditions which would negatively impact on the patient completing the study.
•Clinically significant kidney disease which may prevent the patient from completing the study and/or an elevation in either blood creatinine or urea nitrogen \>1.5 times the laboratory normal.