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Clobazam

(Onfi®)

Onfi®

Drug updated on 11/1/2024

Dosage FormTablet (oral; 10 mg, 20 mg); suspension (oral; 2.5 mg/mL)
Drug ClassBenzodiazepines
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Reduction in Drop Seizures: High-dose clobazam (CLB_H, 1.0 mg/kg/day) was associated with a ≥50% reduction in drop seizure frequency compared to placebo (OR (odds ratio): 4.9; 95% CI (confidence interval): 2.3-10.8), with 78% (95% CI: 70-85%) showing reduction in long-term treatment. High-dose cannabidiol (CBD_H, 20 mg/kg/day) also achieved a ≥50% reduction (OR: 3.8; 95% CI: 1.6-9.0), with 96% (95% CI: 95-98%) showing long-term reduction in seizures.
  • Overall Seizure Frequency Reduction and Responder Rate: Cannabidiol (CBD) treatment resulted in a reduction in primary seizure frequency in patients with LGS (Lennox-Gastaut syndrome) (treatment ratio: 0.70 [95% CI: 0.62-0.80]) and DS (0.71 [95% CI: 0.60-0.83]). The 50% responder rate OR for CBD was 2.51 (95% CI: 1.69-3.71) with clobazam and 2.40 (95% CI: 1.38-4.16) without clobazam.
  • Comparative Effectiveness with Other Drugs: Rufinamide (RFM) and lamotrigine (LTG) both showed high-certainty evidence of a 50% or greater seizure reduction compared to placebo, with RFM benefiting 202 more people per 1000 (CI: 34-567) and LTG benefiting 176 more per 1000 (CI: 30-434).
  • Treatment-Emergent Adverse Events (TEAEs): High-dose CBD showed significantly higher odds for any TEAEs (OR: 3.8; 95% CI: 1.6-9.0) with a long-term TEAE frequency of 96% (95% CI: 95-98%). High-dose clobazam showed high-certainty evidence for adverse events leading to study discontinuation, with 106 more people per 1000 affected (CI: 0 to 538 more) when used as an add-on therapy.
  • Specific Adverse Events: CBD was commonly associated with somnolence, decreased appetite, diarrhea, and increased serum aminotransferases, with higher somnolence and sedation in patients also on clobazam.
  • Studies included pediatric and adult populations with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS), with specific evaluations of cannabidiol (CBD) use both with and without clobazam; CBD showed efficacy in both settings, though higher rates of somnolence and sedation were observed in patients combining CBD with clobazam.