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A Controlled Clinical Trial in Simple Absences, Bilateral Massive Epileptic Myoclonus, and Atonic Seizures

Bent Mikkelsen, MD; Erik Birket-Smith, MD; Sven Brandt, MD; Per Holm, BPharm; Mogens Lund, MD; Ingrid Thorn, MD; Svein Vestermark, MD; Poul Zander Olsen, MD

Arch Neurol. 1976;33(5):322-325.

Abstract
• In a controlled clinical investigation based on ten patients with simple absences and ten patients with myoclonic atonic seizures, all patients who had insufficient response to conventional antiepileptic treatment received clonazepam (Rivotril [Denmark]; Clonopin, comparable US product) combined with previous antiepileptic drugs. The effects of the combined use of clonazepam and the previous antiepileptic drugs were compared with the effects of placebo combined with the same drugs. The trial was single-blind crossover with sequential analysis. In a daily dose of usually 3 to 6 mg, depending on patient age, the antiepileptic effect of clonazepam was significantly superior to placebo and was estimated as remarkably good. Side-effects of somnolence, fatigue, drowsiness, and coordination disturbances occurred in most of the patients, but subsided spontaneously or could be controlled by slow increase or slight reduction of dosage. Mental sideeffects such as agitation, confusion, and aggressiveness were more troublesome and caused discontinuation of clonazepam in two patients.

Author Affiliations
From the departments of neurology, Hjørring Hospital (Dr Mikkelsen), Aalborg Hospital (Dr Birket-Smith), and Glostrup Hospital (Dr Lund); the departments of pediatrics, Rigshospitalet, Copenhagen (Dr Brandt), Gentofte Hospital (Dr Thorn), and Glostrup Hospital (Dr Vestermark); the Department of Clinical Research, Roche Ltd, Hvidovre (Mr Holm); and the Department of Neurophysiology, Gentofte Hospital, Denmark (Dr Olsen).

Footnotes
Accepted for publication April 11, 1975.

Reprint requests to Department of Neurology, Hjørring Hospital, Dk-9800 Hjørring, Denmark (Dr Mikkelsen).