A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study.

Abstract

BACKGROUND:

Rasagiline (n-propargyl-1[R]-aminoindan) mesylate is a novel irreversible selective monoamine oxidase type B inhibitor, previously demonstrated to improve symptoms in early Parkinson disease (PD).

OBJECTIVE:

To determine the safety, tolerability, and efficacy of rasagiline in levodopa-treated patients with PD and motor fluctuations.

DESIGN:

Multicenter, randomized, placebo-controlled, double-blind, parallel-group study.

PATIENTS:

Parkinson disease patients (N = 472) with at least 21/2 hours of daily "off" (poor motor function) time, despite optimized treatment with other anti-PD medications.

INTERVENTIONS:

Rasagiline, 1.0 or 0.5 mg/d, or matching placebo.

MAIN OUTCOME MEASURES:

Change from baseline in total daily off time measured by patients' home diaries during 26 weeks of treatment, percentage of patients completing 26 weeks of treatment, and adverse event frequency.

RESULTS:

During the treatment period, the mean adjusted total daily off time decreased from baseline by 1.85 hours (29%) in patients treated with 1.0 mg/d of rasagiline, 1.41 hours (23%) with 0.5 mg/d rasagiline, and 0.91 hour (15%) with placebo. Compared with placebo, patients treated with 1.0 mg/d rasagiline had 0.94 hour less off time per day, and patients treated with 0.5 mg/d rasagiline had 0.49 hour less off time per day. Prespecified secondary end points also improved during rasagiline treatment, including scores on an investigator-rated clinical global impression scale and the Unified Parkinson's Disease Rating Scale (activities of daily living in the off state and motor performance in the "on" state). Rasagiline was well tolerated.

CONCLUSIONS:

Rasagiline improves motor fluctuations and PD symptoms in levodopa-treated PD patients. In light of recently reported benefits in patients with early illness, rasagiline is a promising new treatment for PD.

• Authors: Parkinson Study Group
• Journal: Archives of neurology (Arch Neurol) Vol. 62 Issue 2 Pg. 241-8 (Feb 2005) ISSN: 0003-9942 [Print] United States
• PMID: 15710852 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiparkinson Agents
• Indans
• Monoamine Oxidase Inhibitors
• rasagiline
• Levodopa

Topics

• Aged
• Aged, 80 and over
• Anorexia (chemically induced)
• Antiparkinson Agents (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Indans (administration & dosage, adverse effects, therapeutic use)
• Levodopa (therapeutic use)
• Male
• Middle Aged
• Monoamine Oxidase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Motor Activity (drug effects, physiology)
• Parkinson Disease (drug therapy, physiopathology)
• Retrospective Studies
• Severity of Illness Index
• Time Factors
• Treatment Outcome
• Vomiting (chemically induced)
• Weight Loss (drug effects)