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A Randomized, Double-blind, Placebo-Controlled Trial of Subcutaneously Injected Apomorphine for Parkinsonian Off-State Events
Richard B. Dewey, Jr, MD;
J. Thomas Hutton, MD, PhD;
Peter A. LeWitt, MD;
Stewart A. Factor, DO
Arch Neurol. 2001;58:1385-1392.
Objective To assess the safety and efficacy of subcutaneous apomorphine hydrochloride
administration for off-state (poor motor function) periods in patients with
Parkinson disease with motor fluctuations under both inpatient titration and
outpatient therapeutic conditions.
Patients and Methods Twenty-nine patients had advanced Parkinson disease with 2 hours or
more off time despite aggressive oral therapy. Patients randomly received
titrated doses of subcutaneous apomorphine hydrochloride (2-10 mg, n = 20)
or pH-matched vehicle placebo (n = 9) during an inpatient and 1-month outpatient
phase. A change in the United Parkinson Disease Rating Scale motor score 20
minutes after inpatient dosing during a practically defined off-state event
and the percentage of injections successfully aborting off-state events were
the primary inpatient and outpatient efficacy factors.
Results The average (SEM) levodopa equivalent dose of apomorphine hydrochloride
was 5.4 ± 0.5 mg and the mean placebo dose was 1.0 mL. Mean inpatient
United Parkinson Disease Rating Scale motor scores were reduced by 23.9 and
0.1 points (62% and 1%) by apomorphine treatment and placebo, respectively
(P<.001). The mean percentage of outpatient injections
resulting in successful abortion of off-state events was 95% for apomorphine
and 23% for placebo (P<.001). Inpatient response
was significantly correlated with and predictive of outpatient efficacy (P<.001). The levodopa dose was not predictive of the
apomorphine dose requirement. Frequent adverse events included dyskinesia,
yawning, and injection site reactions.
Conclusion Apomorphine by intermittent subcutaneous injection is effective and
safe for outpatient use to reverse off-state events that occur despite optimized
oral therapy.
From the Department of Neurology, University of Texas Southwestern
Medical Center, Dallas (Dr Dewey); Neurology Research and Education Center,
Covenant Medical Center, Lubbock, Tex (Dr Hutton); Clinical Neuroscience Center,
Southfield, Mich (Dr LeWitt); and the Department of Neurology, Albany Medical
College, Albany, NY (Dr Factor).
Corresponding author: Richard B. Dewey, Jr, MD, University of Texas
Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9036.
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