Trial record 5 of 25 for:    PARKINSON DISEASE 12

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00402233
First received: November 19, 2006
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: Pramipexole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Modified Hoehn and Yahr Stage [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)

  • Epworth Sleepiness Scale [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)

  • Beck Depression Inventory II [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
    Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)


Enrollment: 312
Study Start Date: November 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Drug: Placebo
Pramipexole 0.5 mg Tid
Pramipexole 0.5 mg tid (three times a day)
Drug: Pramipexole
Pramipexole 0.5 mg Bid
Pramipexole 0.5 mg bid (bis in die (two times a day))
Drug: Pramipexole
Pramipexole 0.75 mg Bid
Pramipexole 0.75 mg bid (bis in die (two times a day))
Drug: Pramipexole

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402233

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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00402233     History of Changes
Other Study ID Numbers: 248.622, PramiBID
Study First Received: November 19, 2006
Results First Received: September 22, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014