A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)

Boehringer Ingelheim39 sites in 1 country312 target enrollmentNovember 2006

ConditionsParkinson Disease

InterventionsPlacebo Pramipexole

DrugsPramipexole Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 312
Locations: 39
Primary Endpoint: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.

Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

September 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Potential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
•Must be willing and able to give informed consent.
•Must be over 30 years of age at Baseline.
•Must have idiopathic Parkinson's disease of less than 7 years duration since diagnosis, characterized by 2 of the following 3 cardinal signs (signs need to be asymmetric): resting tremor, bradykinesia and rigidity.
•Must have a Modified Hoehn and Yahr stage \<
•Should be able to safely tolerate placebo for up to 12 weeks after Baseline.
•Must have a negative urine pregnancy test at the Screening Visit and use an adequate contraceptive method throughout the study if a woman of child-bearing potential. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives intrauterine devices in place for at least 3 months estrogen patch and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen.
•Must be willing and able to comply with trial procedures. They must be sufficiently proficient in English to understand and complete study instruments.

Exclusion Criteria

•Individuals with any of the following characteristics will not be eligible for entry into this study:
•Signs or symptoms suggesting other parkinsonian syndromes.
•Use of medications that may cause secondary parkinsonism, including but not limited to: neuroleptics, metaclopramide, alphamethyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamines in the last 6 months prior to Baseline Visit.
•Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.
•Presence of dementia by Diagnostic and Statistical Manual of Mental Disorders IV criteria (R06-1340) or a Mini Mental State Examination (R96-2656) (Appendix 10.1) score less than 26 at Screening Visit.
•Presence of major depression, as determined by medical history.
•Active epilepsy (i.e., occurrence of a seizure) within the past year prior to Baseline Visit.
•Electro Convulsive Therapy in previous 90 days prior to Baseline Visit.
•Myocardial infarction within previous 6 months prior to Baseline Visit.
•Third degree atrioventricular block or sick sinus syndrome.

Arms & Interventions

Placebo

Intervention: Placebo

Pramipexole 0.5 mg Tid

Pramipexole 0.5 mg tid (three times a day)

Intervention: Pramipexole

Pramipexole 0.5 mg Bid

Pramipexole 0.5 mg bid (bis in die (two times a day))

Intervention: Pramipexole

Pramipexole 0.75 mg Bid

Pramipexole 0.75 mg bid (bis in die (two times a day))

Intervention: Pramipexole

Outcomes

Primary Outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

Time Frame: From baseline to week 12

Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)