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A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study.
Arch Neurol. 2005 Feb; 62(2):241-8.AN

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

No affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15710852

Citation

Parkinson Study Group. "A Randomized Placebo-controlled Trial of Rasagiline in Levodopa-treated Patients With Parkinson Disease and Motor Fluctuations: the PRESTO Study." Archives of Neurology, vol. 62, no. 2, 2005, pp. 241-8.
Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005;62(2):241-8.
Parkinson Study Group. (2005). A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Archives of Neurology, 62(2), 241-8.
Parkinson Study Group. A Randomized Placebo-controlled Trial of Rasagiline in Levodopa-treated Patients With Parkinson Disease and Motor Fluctuations: the PRESTO Study. Arch Neurol. 2005;62(2):241-8. PubMed PMID: 15710852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. A1 - ,, PY - 2005/2/16/pubmed PY - 2005/4/2/medline PY - 2005/2/16/entrez SP - 241 EP - 8 JF - Archives of neurology JO - Arch Neurol VL - 62 IS - 2 N2 - 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. SN - 0003-9942 UR - https://www.unboundmedicine.com/medline/citation/15710852/A_randomized_placebo_controlled_trial_of_rasagiline_in_levodopa_treated_patients_with_Parkinson_disease_and_motor_fluctuations:_the_PRESTO_study_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/archneur.62.2.241 DB - PRIME DP - Unbound Medicine ER -