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Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study.

Barry E Gidal1, Robert T Wechsler2, Raman Sankar2

  • 1From the School of Pharmacy and Department of Neurology (B.E.G.), University of Wisconsin, Madison; Idaho Comprehensive Epilepsy Center (R.T.W.), Boise; David Geffen School of Medicine at UCLA (R.S.), University of California-Los Angeles; School of Medicine (G.D.M.), Boston University, MA; School of Pharmacy (H.S.W.), University of Washington, Seattle; Center for Orphan Drug Research (J.C.C.), College of Pharmacy, University of Minnesota, Minneapolis; Prescott Medical Communications Group (M.C.K.), Chicago, IL; and Lundbeck LLC (G.P., D.M.T., V.S., J.I.), Deerfield, IL. barry.gidal@wisc.edu.

Neurology
|September 30, 2016
PubMed
Summary

This study found that most patients with Lennox-Gastaut syndrome do not develop tolerance to clobazam, an antiseizure medication. Dosage increases were often to achieve seizure freedom, not due to tolerance.

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Area of Science:

  • Neurology
  • Pharmacology
  • Epilepsy Research

Background:

  • Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy.
  • The potential for tolerance development to antiseizure medications like clobazam is a clinical concern.
  • Previous observations suggested possible tolerance to clobazam in LGS patients.

Purpose of the Study:

  • To evaluate the development of tolerance to adjunctive clobazam in patients diagnosed with Lennox-Gastaut syndrome.
  • To assess long-term efficacy and dosage adjustments of clobazam over a 2-year period.
  • To determine if increased seizure rates correlate with dosage increases, indicating tolerance.

Main Methods:

  • Open-label extension study (OV-1004) involving 200 patients with LGS.
  • Clobazam dosage initiated at 0.5 mg·kg⁻¹·d⁻¹ and adjusted up to 2.0 mg·kg⁻¹·d⁻¹ based on efficacy and tolerability.
  • Post hoc analyses examined dosage changes and seizure rates in relation to responder status and baseline seizure severity.

Main Results:

  • No significant dosage changes were observed in patients who achieved freedom from drop seizures.
  • Dosages were increased in responder groups still experiencing drop seizures.
  • Consistent seizure control was observed in 100% and ≥75% responders over time.
  • Few patients showed dosage increases linked to worsening seizure rates.

Conclusions:

  • The majority of patients with LGS do not appear to develop tolerance to clobazam over two years.
  • Dosage increases were primarily associated with efforts to achieve complete seizure control.
  • The clinical significance of clobazam tolerance in LGS may have been overestimated.