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Movement Disorders and Neurodegenerative Diseases Clinic and Fellowship Program

STUDY 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)

    Inclusion Criteria
  • Women and men over 30 years of age with idiopathic Parkinson’s disease of less than 7 years duration.
  • Subjects must be in Hoehn and Yahr stage 1-3.
  • They may be approaching the time of needing dopaminergic therapy to treat PD symptoms, but are not expected to require symptomatic therapy within the next 12 weeks after Baseline Visit.
    Exclusion Criteria
  • Signs or symptoms suggesting other parkinsonian syndromes; use of medications that may cause secondary parkinsonism; prior steriotactic brain surgery, dementia, active epilepsy, pregnancy or major depression.
  • Use of dopaminergic medications within the last 3 months or for longer than 6 months prior to Baseline Visit.
  • Clinically significant heart, renal or liver disease, or any other clinically significant medical or psychiatric conditionthat in the judgment of the investigator would interfere with the subject’s ability to participate in the study or would jeopardize safe conduct of the study.

STUDY TITLE: 123 I-ALTROPANE® Reference Image Acquisition in Subjects with Diagnostically Uncertain Tremor (AIM)

    Inclusion Criteria
  • Women and men over 40 years of age with upper extremity tremor for less than 2 years duration.
    Exclusion Criteria
  • Any clinically significant medical or psychiatric condition that in the judgment of the investigator would interfere with the subject’s ability to participate in the study or would jeopardize safe conduct of the study, especially active thyroid disease, cerebrovascular disease, uncontrolled diabetes or hypertension, history of encephalitis or history of repeated or severe head injury within the year before onset of the tremor.
  • Abnormal labs or ECG obtained on visit 1.
  • Positive drug screen or pregnancy test.
  • Previous exposure to radiopharmaceuticals within 30 days or treatment with anti-tremor medication within 3 months.
  • New Rx medication or change in dosage within 4 weeks of visit 2.
  • Previous evaluation by MDS.
  • Treatment within 6 months with bupropion, metoclopramide, cinnarizine, alpha methyldopa, amphetamine, or any anti-psychotic medication.

 

 

 

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    August 28, 2009

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