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
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Pramipexole; Placebo
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 31 Years
Healthy volunteers: No

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
    

Eligibility 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.