A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
NCT ID: NCT00402233
Last Updated: 2014-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
312 participants
INTERVENTIONAL
2006-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Pramipexole 0.5 mg Tid
Pramipexole 0.5 mg tid (three times a day)
Pramipexole
Pramipexole 0.5 mg Bid
Pramipexole 0.5 mg bid (bis in die (two times a day))
Pramipexole
Pramipexole 0.75 mg Bid
Pramipexole 0.75 mg bid (bis in die (two times a day))
Pramipexole
Interventions
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Pramipexole
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
31 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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248.622.170 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
248.622.112 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
248.622.69 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
248.622.198 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
248.622.111 Boehringer Ingelheim Investigational Site
Oxnard, California, United States
248.622.61 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
248.622.23 Boehringer Ingelheim Investigational Site
San Diego, California, United States
248.622.73 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
248.622.108 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
248.622.190 Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
248.622.215 Boehringer Ingelheim Investigational Site
Manchester, Connecticut, United States
248.622.196 Boehringer Ingelheim Investigational Site
Boca Raton, Florida, United States
248.622.14 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
248.622.149 Boehringer Ingelheim Investigational Site
Weston, Florida, United States
248.622.139 Boehringer Ingelheim Investigational Site
Honolulu, Hawaii, United States
248.622.5 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
248.622.138 Boehringer Ingelheim Investigational Site
Springfield, Illinois, United States
248.622.87 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
248.622.207 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
248.622.132 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
248.622.17 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
248.622.40 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
248.622.76 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
248.622.186 Boehringer Ingelheim Investigational Site
East Lansing, Michigan, United States
248.622.77 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
248.622.155 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
248.622.135 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
248.622.216 Boehringer Ingelheim Investigational Site
Kingston, New York, United States
248.622.202 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.622.86 Boehringer Ingelheim Investigational Site
New York, New York, United States
248.622.1 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
248.622.89 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
248.622.20 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
248.622.169 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania, United States
248.622.18 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
248.622.199 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
248.622.7 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
248.622.213 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
248.622.104 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PramiBID
Identifier Type: -
Identifier Source: secondary_id
248.622
Identifier Type: -
Identifier Source: org_study_id
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