Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: rasagiline mesylate; Drug: 1.0 mg rasagiline mesylate; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203034

TV-1012/133

Details and patient eligibility

About

Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo

Enrollment: 472 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.

Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state.

Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.

Selegiline must be discontinued for at least 90 days prior to baseline.

Subject must be age 30 or older.

Subjects must be willing and able to give informed consent.

Exclusion criteria

Subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)] within the 12 months preceding the Baseline visit.

Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS.

Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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472 participants in 3 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

0.5 mg rasagiline mesylate oral once daily

Treatment:

Drug: rasagiline mesylate

Experimental 2

Experimental group

Description:

1.0 mg rasagiline mesylate oral once daily

Treatment:

Drug: 1.0 mg rasagiline mesylate

Placebo

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Other: Placebo