Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

Chongqing Fortune Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Parkinson´s Disease

Treatments: Drug: Placebo; Drug: Rasagiline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01736891

RLPDMF2010L03416

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Full description

Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Enrollment: 268 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with idiopathic PD
• Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
• Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
• Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
• Patients who have demonstrated the ability to keep accurate 24-hour diaries

Exclusion criteria

• Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
• Patients with severe cognitive impairment judged by a Mini Mental State Examination
• Patients with a clinically significant psychiatric illness
• Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
• Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
• Patients with a clinically significant or unstable vascular disease
• Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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268 participants in 2 patient groups, including a placebo group

Rasagiline

Experimental group

Description:

Rasagiline 0.5 mg by mouth every day for 2 weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)

Treatment:

Drug: Rasagiline

Placebo

Placebo Comparator group

Description:

placebo 0.5 mg by mouth every day for two weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)

Treatment:

Drug: Placebo