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

Teva Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Rasagiline

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01049984

TVP-1012/PM103

Details and patient eligibility

About

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.

Enrollment

328 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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
1. 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