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A rd, db, Placebo Cnt, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12 w Treatment in Early PD Patients
This study has been completed.
First Received: November 19, 2006   Last Updated: February 4, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00402233
  Purpose

To verify if Mirapex given twice a day, vs three times a day, in early PD patients, is effective and safe.


Condition Intervention Phase
Parkinson Disease
Drug: Pramipexole
Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint for this study is the clinical response after 12 weeks of treatment, defined as a change in total Unified Parkinsons Disease Rating Scale (UPDRS) score from the Baseline to Week 12 Visit. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Modified Hoehn and Yahr Stage Epworth Sleepiness Scale Beck Depression Inventory II (BDI II) [ Time Frame: 12 weeks ]

Enrollment: 311
Study Start Date: November 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 PD 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 Ba seline 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 DSM IV criteria (R06-1340) or a MMSE (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 AV block or sick sinus syndrome.
  10. Congestive heart failure Class III or IV by NYHA.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402233

  Show 39 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.622, PramiBID
Study First Received: November 19, 2006
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00402233     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Ganglion Cysts
Antioxidants
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dopamine Agonists
Pramipexol
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009