Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Neuroscience, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Dopamine; Dopamine Agents; Dopamine Agonists; Rasagiline

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