Trial | NCT01736891  Report issue

Title

Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rasagiline ...

  • Study Participants

    268
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.
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.
Study Started
Nov 30
2011
Primary Completion
Jun 30
2013
Study Completion
Jun 30
2013
Last Update
Sep 13
2013
Estimate

Drug Rasagiline

Tablets, qd

  • Other names: Azilect

Drug Placebo

Tablets, qd

Rasagiline Experimental

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)

Placebo Placebo Comparator

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)

Criteria 

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
No Results Posted