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

Completed · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01049984

Run by

Teva Neuroscience, Inc.

People needed

328

Starts

2009-12-01

Expected to finish

2012-10-01

Last updated by the study team

2016-05-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Teva Investigational Site 42 — Sun City, Arizona, United States
• Teva Investigational Site 15 — Fountain Valley, California, United States
• Teva Investigational Site 19 — Fresno, California, United States
• Teva Investigational Site 36 — Fresno, California, United States
• Teva Investigational Site 04 — La Jolla, California, United States
• Teva Investigational Site 29 — Reseda, California, United States
• Teva Investigational Site 69 — San Francisco, California, United States
• Teva Investigational Site 02 — Sunnyvale, California, United States
• Teva Investigational Site 43 — Ventura, California, United States
• Teva Investigational Site 44 — Fairfield, Connecticut, United States
• Teva Investigational Site 07 — Manchester, Connecticut, United States
• Teva Investigational Site 25 — Newark, Delaware, United States
• Teva Investigative Site 63 — Atlantis, Florida, United States
• Teva Investigational Site 30 — Boca Raton, Florida, United States
• Teva Investigational Site 13 — Clearwater, Florida, United States
• Teva Investigational Site 70 — Sunrise, Florida, United States
• Teva Investigational Site 41 — Tampa, Florida, United States
• Teva Investigational Site 61 — Vero Beach, Florida, United States
• Teva Investigational Site 01 — Decatur, Georgia, United States
• Teva Investigational Site 58 — Boise, Idaho, United States
• Teva Investigational Site 49 — Glenview, Illinois, United States
• Teva Investigational Site 23 — Peoria, Illinois, United States
• Teva Investigational Site 47 — Indianapolis, Indiana, United States
• Teva Investigational Site 67 — Indianapolis, Indiana, United States
• Teva Investigational Site 34 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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