Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: placebo; Drug: Rasagiline Mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203060

TVP-1012/232

Details and patient eligibility

About

Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.

Enrollment: 404 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Subjects must be age 35 years or older.

Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.

Exclusion criteria

Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease

Trial design

404 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Rasagiline treatment

Treatment:

Drug: Rasagiline Mesylate

B

Placebo Comparator group

Description:

placebo arm

Treatment:

Drug: placebo