Clobazam

Evidence Level: L4

Predicted Indications: 10

Clobazam

Pharmacist Assessment Report

One-Sentence Summary

Clobazam is a benzodiazepine anti-seizure medication, originally used for Lennox-Gastaut syndrome. The TxGNN model predicts it may be effective for febrile infection-related epilepsy syndrome (FIRES), but at present there are no registered clinical trials and only 2 publications (a case series and a case report), neither of which studied clobazam directly.

Quick Overview

Item	Content
Original Indication	Lennox-Gastaut syndrome (the licence entries in India carry no indication text)
Predicted New Indication	Febrile infection-related epilepsy syndrome
TxGNN Prediction Score	0.9982
Evidence Level	L4
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, clobazam is a GABA-A positive allosteric modulator, like other benzodiazepines. Its efficacy in Lennox-Gastaut syndrome, a severe drug-resistant epilepsy, is established, and mechanistically it may be applicable to other refractory epilepsies.

FIRES is a severe form of new-onset refractory status epilepticus that occurs in previously healthy children. Seizures are often resistant to conventional anti-seizure drugs and are managed with benzodiazepines such as midazolam, or with other anaesthetics. A class-effect link to clobazam is therefore plausible. However, the retrieved publications describe lorazepam weaning and perampanel, not clobazam, so the link remains unproven.

Other predicted indications are listed below for context. Only childhood-onset epileptic encephalopathy has meaningful supporting literature, and that is largely an extension of the existing Lennox-Gastaut indication rather than true repurposing.

Rank	Predicted Indication	TxGNN Score	Evidence Level	Note
2	Perioral myoclonia with absences	0.9979	L5	Prediction only
3	Cryptogenic late-onset epileptic spasms	0.9977	L5	One cohort study, no clobazam efficacy data
4	Atypical childhood epilepsy with centrotemporal spikes	0.9977	L5	General reviews and case series
5	Photosensitive occipital lobe epilepsy	0.9977	L5	One 1994 regional report
6	Childhood onset epileptic encephalopathy	0.9959	L5	Reviews and guidelines; largely an extension of the existing indication
7	Benign occipital epilepsy	0.9958	L5	Includes Cochrane review of clobazam monotherapy; usually self-limited disease
8	GRIN2A-related early-onset epileptic encephalopathy	0.9940	L5	Prediction only
9	Restless legs syndrome	0.9930	L5	Prediction only; weak class-level rationale
10	Polymicrogyria with optic nerve hypoplasia	0.9909	L5	Prediction only

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
35770765	2022	Case series	Epileptic Disorders	Enteral lorazepam as a weaning substitute in midazolam-dependent FIRES patients; clobazam not studied
39958143	2025	Case report	Cureus	Perampanel may reduce barbiturate dependency in a 13-year-old boy with FIRES; clobazam not studied

India Market Information

Clobazam is marketed in India as a single-ingredient oral tablet (20 valid registrations, none cancelled). The data compiled for this report contain no approved-indication text for these licences. Five representative registrations:

Authorization Number	Product Name	Dosage Form	Approved Indication
Registration No. 80614	Ericlob 10 Tablet	Strip of 10 tablets	Not stated
Registration No. 204573	Sebenz 5mg Tablet	Strip of 10 tablets	Not stated
Registration No. 84073	Frisium 10mg Tablet	Strip of 15 tablets	Not stated
Registration No. 36105	Cloba MT 2.5 Tablet MD	Strip of 10 tablets (MD)	Not stated
Registration No. 155298	Nucloba 5 Tablet DT	Strip of 10 tablets (DT)	Not stated

Safety Considerations

Drug Interactions: 100 interactions were identified. Major-level interactions include:
- Morphine (including liposomal morphine): additive central nervous system and respiratory depression
- Eliglustat
Moderate-level interactions include bupropion, aprepitant, omeprazole, esomeprazole, lansoprazole, cimetidine, clarithromycin, metoclopramide, dronabinol, fenfluramine and dexfenfluramine. Minor interactions include antacids (magnesium oxide, aluminium hydroxide, calcium carbonate, and others).

Please refer to the package insert for warnings and contraindications, as these were not available in the data compiled for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is very high, but there are no clinical trials, and the only two publications on FIRES concern other drugs (lorazepam and perampanel). Evidence is limited to a plausible benzodiazepine class effect. Of the other predicted indications, only childhood-onset epileptic encephalopathy has supporting literature, and that largely overlaps the already-approved Lennox-Gastaut use.

To proceed, the following is needed:

Clobazam-specific data in FIRES, such as case series, registry data or a prospective study
Mechanism of action data for clobazam
Package insert warnings and contraindications from the India regulator, to allow safety screening
A review of the major interactions (opioids in particular), given that FIRES patients are often on multiple sedatives
Confirmation of the approved indications on the India licences
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.