Published Online
on December 26, 2002

A more recent version of this article appeared on February 1, 2003

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Submitted on August 15, 2002
Accepted on August 27, 2002

Safety of Dexamphetamine in Acute Ischemic Stroke. A Randomized, Double-Blind, Controlled Dose-Escalation Trial

Louise Martinsson PT, MSc^* and Nils Gunnar Wahlgren MD, PhD

From the Institution of Clinical Neurosciences (L.M., N.G.W.), Karolinska Institute, and Department of Neurology, Karolinska Hospital (N.G.W.), Stockholm, Sweden.

^* To whom correspondence should be addressed. E-mail: louise.martinsson{at}ks.se.

Background and Purpose—Amphetamine is reported to enhance recovery after experimental stroke, but results from the first few trials in humans are inconclusive. Limited information is available on treatment safety. This study intended to investigate the safety and tolerability of dexamphetamine in patients with acute cerebral ischemia.

Methods—Forty-five patients with cerebral ischemia were enrolled within 72 hours after onset of symptoms. Patients were randomized to 1 of 3 dose levels (2.5, 5, or 10 mg orally twice daily) or placebo for 5 consecutive days. Adverse events, blood pressure, heart rate, body temperature, consciousness level, and functional outcome measures were followed up daily during treatment. Follow-ups were made at day 7 and 1 and 3 months after stroke.

Results—Mean systolic and diastolic blood pressures and heart rate increased 14 mm Hg, 8 mm Hg, and 9 bpm, respectively, with dexamphetamine treatment compared with placebo (P0.01). There was no difference between dexamphetamine and placebo regarding adverse events, body temperature, or consciousness level. During treatment, there was a benefit of dexamphetamine in neurological and functional outcome (P<0.05), but differences were not maintained at follow-up.

Conclusions—Overall, dexamphetamine was safe and well tolerated by patients with acute cerebral ischemia, but blood pressure and heart rate increased during treatment in comparison to placebo. These observations may be important in the future planning of amphetamine trials because changes in these variables have been observed to interfere with clinical outcome. The suggestions of improvement in outcome must be confirmed in further studies.

Key words: blood pressure • cerebral infarction • dextroamphetamine • recovery of function • safety

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