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A controlled trial on clonazepam INN (Ro 5-4023, Rivotril (R)) in the treatment of focal epilepsy and secondary
Abstract:
In a controlled clinical investigation based on 14 patients with focal seizures and 3 patients with secondary generalized grand mal epilepsy, all with insufficient response to conventional anti-epileptic treatment, clonazepam (Rivotril(R)) combined with previous anti-epileotic drugs was compared with placebo combined with the same drugs. The trial was singleblind cross-over with sequential analyses. With a daily dose, depending upon age, of usually 3-6 mg, the antiepileptic effect of Clonazepam was significantly superior to placebo and was estimated as remarkably good. Side-effects in the form of somnolence, fatique, drowsiness and co-ordination disturbances occurred in most of the patients but subsided spontaneously or could be managed by slow increase or slight reduction in dosage.
Insights
Clonazepam significantly improved seizure control in patients with epilepsy unresponsive to other treatments. While side effects like drowsiness occurred, they were manageable, indicating clonazepam
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Epilepsy is a neurological disorder characterized by recurrent seizures.
- Conventional anti-epileptic drugs (AEDs) are not effective for all patients.
- Refractory epilepsy necessitates exploring alternative or adjunctive treatments.
Purpose of the Study:
- To evaluate the efficacy and tolerability of clonazepam as an add-on therapy for epilepsy.
- To compare clonazepam combined with existing AEDs against placebo combined with existing AEDs.
Main Methods:
- A controlled, single-blind, cross-over clinical investigation.
- Sequential analyses were employed to assess treatment outcomes.
- Participants included 14 patients with focal seizures and 3 with secondary generalized grand mal epilepsy.
Main Results:
- Clonazepam demonstrated significantly superior anti-epileptic effects compared to placebo.
- The efficacy of clonazepam was rated as remarkably good.
- Common side effects included somnolence, fatigue, drowsiness, and coordination disturbances, which were generally manageable.
Conclusions:
- Clonazepam is an effective adjunctive treatment for patients with refractory focal and secondary generalized epilepsy.
- The observed side effects of clonazepam are typically manageable through dosage adjustments.
- Further research may explore optimal dosing strategies for clonazepam in specific epilepsy subtypes.