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)
- NCT00402233
- PHASE4
- INTERVENTIONAL
Last updated: 2014-05-16
Purpose of Trial
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
This study is for people with
Parkinson Disease
Interventions being studied
Pramipexole
Placebo
Inclusion Criteria:
Potential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
1. Must be willing and able to give informed consent.
2. Must be over 30 years of age at Baseline.
3. 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.
4. Must have a Modified Hoehn and Yahr stage \<3.
5. Should be able to safely tolerate placebo for up to 12 weeks after Baseline.
6. 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.
7. 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:
1. Signs or symptoms suggesting other parkinsonian syndromes.
2. 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.
3. Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.
4. 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.
5. Presence of major depression, as determined by medical history.
6. Active epilepsy (i.e., occurrence of a seizure) within the past year prior to Baseline Visit.
7. Electro Convulsive Therapy in previous 90 days prior to Baseline Visit.
8. Myocardial infarction within previous 6 months prior to Baseline Visit.
9. Third degree atrioventricular block or sick sinus syndrome.
10. Congestive heart failure Class III or IV by New York Heart Association classification.
11. Symptomatic orthostatic hypotension at Screening Visit.
12. Stereotaxic brain surgery.
13. Clinically significant liver disease.
14. Clinically significant renal disease.
15. Any other clinically significant medical or psychiatric condition (e.g., angina, active neoplasm) that in the judgment of the investigator would interfere with the subjects ability to participate in the study or would jeopardize safe conduct of the study.
16. Breastfeeding.
17. Known hypersensitivity or intolerability to pramipexole.
18. Participating in other drug studies or receiving other experimental medications within 30 days of Baseline Visit.
19. History of drug or alcohol dependency within 6 months of baseline visit.
ELIGIBILITY
Gender: ALL
Age: 31+
Healthy Volunteers: No
39 Locations
Phoenix
248.622.170 Boehringer Ingelheim Investigational Site
Arizona, United States
Little Rock
248.622.112 Boehringer Ingelheim Investigational Site
Arkansas, United States
Fountain Valley
248.622.69 Boehringer Ingelheim Investigational Site
California, United States
La Jolla
248.622.198 Boehringer Ingelheim Investigational Site
California, United States
Oxnard
248.622.111 Boehringer Ingelheim Investigational Site
California, United States
Sacramento
248.622.61 Boehringer Ingelheim Investigational Site
California, United States
San Diego
248.622.23 Boehringer Ingelheim Investigational Site
California, United States
San Francisco
248.622.73 Boehringer Ingelheim Investigational Site
California, United States
Denver
248.622.108 Boehringer Ingelheim Investigational Site
Colorado, United States
Danbury
248.622.190 Boehringer Ingelheim Investigational Site
Connecticut, United States
Manchester
248.622.215 Boehringer Ingelheim Investigational Site
Connecticut, United States
Boca Raton
248.622.196 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
248.622.14 Boehringer Ingelheim Investigational Site
Florida, United States
Weston
248.622.149 Boehringer Ingelheim Investigational Site
Florida, United States
Honolulu
248.622.139 Boehringer Ingelheim Investigational Site
Hawaii, United States
Chicago
248.622.5 Boehringer Ingelheim Investigational Site
Illinois, United States
Springfield
248.622.138 Boehringer Ingelheim Investigational Site
Illinois, United States
Louisville
248.622.87 Boehringer Ingelheim Investigational Site
Kentucky, United States
New Orleans
248.622.207 Boehringer Ingelheim Investigational Site
Louisiana, United States
Shreveport
248.622.132 Boehringer Ingelheim Investigational Site
Louisiana, United States
Boston
248.622.17 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Boston
248.622.40 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Boston
248.622.76 Boehringer Ingelheim Investigational Site
Massachusetts, United States
East Lansing
248.622.186 Boehringer Ingelheim Investigational Site
Michigan, United States
Omaha
248.622.77 Boehringer Ingelheim Investigational Site
Nebraska, United States
Lebanon
248.622.155 Boehringer Ingelheim Investigational Site
New Hampshire, United States
Brooklyn
248.622.135 Boehringer Ingelheim Investigational Site
New York, United States
Kingston
248.622.216 Boehringer Ingelheim Investigational Site
New York, United States
New York
248.622.202 Boehringer Ingelheim Investigational Site
New York, United States
New York
248.622.86 Boehringer Ingelheim Investigational Site
New York, United States
Rochester
248.622.1 Boehringer Ingelheim Investigational Site
New York, United States
Cincinnati
248.622.89 Boehringer Ingelheim Investigational Site
Ohio, United States
Columbus
248.622.20 Boehringer Ingelheim Investigational Site
Ohio, United States
Hershey
248.622.169 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Philadelphia
248.622.18 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Houston
248.622.199 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
248.622.7 Boehringer Ingelheim Investigational Site
Texas, United States
Spokane
248.622.213 Boehringer Ingelheim Investigational Site
Washington, United States
Milwaukee
248.622.104 Boehringer Ingelheim Investigational Site
Wisconsin, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov