Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rasagiline; Placebo
Intervention description: 1mg tablet daily for 18 weeks; one tablet daily for 18 weeks
Intervention MeSH terms: Rasagiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; UPDRS; Clinical Global Evaluation Illness Severity score; Clinical Global Evaluation Improvement; B-SIT; SCOPA - Sleep Daytime Sleepiness; PDQ -39; SCOPA - Cognition; Levodopa; rasagiline; Dopamine Agonist Therapy; monoamine oxidase type B inhibitor

Summary:

      To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist
      therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine
      agonists as compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving stable dose of oral ropinirole or pramipexole whose symptoms are not
             optimally controlled or whose oral dopamine agonist titration regimen was truncated
             due to intolerability:

          -  1) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for
             pramipexole

          -  2) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer
             than 5 years preceding baseline

          -  Males and females. Women of childbearing potential must agree to practice an
             acceptable method of birth control.

          -  Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal
             signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of
             Parkinsonism

          -  Hoehn & Yahr > 1 (symptoms on only one side of the body) with treatment and < 3 (mild
             to moderate bilateral disease; some postural instability; physically independent).

          -  Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.

          -  For patients who are receiving amantadine or anticholinergics, the dose must have been
             stable for ≥30 days prior to screening.

          -  Medically stable outpatients (Investigator's judgment).

        Exclusion Criteria:

          -  receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding
             baseline

          -  receive levodopa > 21 consecutive days within 90 days prior baseline

          -  moderate to severe motor fluctuations

          -  hepatic impairment

          -  investigational medications 30 days preceding baseline

          -  dopamine agonist use > 5 years prior to baseline

          -  major depression as defined by Beck Depression Inventory (BDI) short form score
             greater than 14

          -  significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score
             less than 26.

          -  impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive
             Disorders in Parkinson's Disease form (QUIP).

          -  pregnant or lactating or planning on becoming pregnant in the next 18 weeks

          -  uncontrolled hypertension. Patients whose hypertension is controlled with medications
             are eligible.

          -  Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO
             inhibitors not allowed