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Intermittent Apomorphine Helps Reduce Motor Fluctuations in Parkinson's Disease: Presented at MDS

By Paula Moyer

ROME, ITALY -- June 18, 2004 -- Patients treated with intermittent apomorphine experience significant improvements in motor fluctuations, according to findings presented here at the 8th International Congress of the Movement Disorder Society.

"We saw significant improvement, within a few minutes, of several motor symptoms of Parkinson's [patients] over placebo," said principal investigator Keith L. Hull, Jr, MD, cofounder and partner, Raleigh Neurology Associates, Raleigh, North Carolina.

To determine whether injections of intermittent subcutaneous apomorphine would help rescue patients rapidly from the bothersome so-called "off" episodes of motor fluctuations that occur despite optimized treatment with currently available antiParkinson's medications, they recruited 62 patients with idiopathic Parkinson's disease.

The randomized, double-blind, parallel-group, single-dose, placebo-controlled study involved 45 men and 17 women, who averaged 65.5 years old and had their disease for an average of 14.7 years. All patients had motor complications despite optimum treatment with levodopa/carbidopa plus at least one oral dopamine agonist. Patients had received apomorphine for at least 3 months before entering the study; the average use duration was 434 days.

Patients were assigned to 1 of 4 treatment groups receiving a single dose of the patient's typically effective dose of apomorphine; the typically effective dose of apomorphine plus an additional 2.0 mg; a placebo injection at the volume equal to the patient's typically effective dose; or placebo at a volume equal to the typically effective dose plus 0.2 mL.

The primary efficacy parameter was a change from the predose assessment using the Unified Parkinson's Disease Rating Scale (UPDRS) motor score measured at 10, 20, and 90 minutes after treatment. The investigators also used the Webster's Step Seconds Test (WSS) at 2.5, 5, 7.5, 10, 15, 20, and 40 minutes after treatment.

The findings show significant improvement in WSS scores 7.5 minutes after treatment. This improvement, a decrease of 200 seconds in comparison with the placebo group, continued for at least 40 minutes after treatment. The investigators also observed significantly superior UPDRS motor scores following the apomorphine injection in comparison with placebo at 10 minutes, a mean reduction of 19.9 compared to 5.6 in placebo (P =.0001). The difference at 20 minutes was a decrease of 24.2 in the treatment group compared to 7.4 in placebo (P =.0001).

No significant improvements were detected in UPDRS and WSS scores with apomorphine at the typically effective dose plus 2.0 mg in comparison with the typically effective dose.

There were no overall significant differences in the rates of adverse effects between the placebo and treatment groups. A slightly higher rate of adverse events occurred in the group getting the typically effective dose of apomorphine plus 2.0 mg, but the difference was not statistically significant.


[Presentation title: Onset of Action of Intermittent Subcutaneous Apomorphine in the Treatment of "Off" Episodes in Patients With Advanced Parkinson's Disease. Abstract P607]

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