Abstract

Clinical trials for periods of 3 months to 3 years in 100 children treated as outpatients (two-thirds of them had had previous unsuccessful treatment before receiving clonazepam (Ro 5-4023) as an adjunct while one-third were new cases treated with clonazepam alone) yielded the following main results: 1. Clonazepam is suitable for long-term treatment. It has a greater consistency of action than nitrazepam. “Relapses” are encountered for the most part in cases exhibiting a phasic course (Lennox-syndrome, psychomotor epilepsies). 2. Freedom from seizures was obtained in 44 per cent of cases. Differences in the susceptibility to treatment of the various types of seizure cannot be demonstrated with certainty. 3. This renders it difficult to define a precise range of indications in terms of seizure type. By contrast, the EEG changes that are immediately evident on i. v. administration (“injection test”) serve as a useful criterion in selecting suitable cases for oral maintenance therapy. 4. The initial side effects considered by many particularly troublesome in the early days of clinical testing were largely due to excessive dosage or too rapid incrementation. Maintenance doses of 0.05 to a maximum of 0.2 mg/kg per day usually suffice and are well tolerated if the increase is effected at a suitable slow rate. 5. The better results seen with clonazepam alone would seem to be related to the type of patient selected (e. g. new cases, often with the “injection test” as a selective criterion).

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