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Related Experiment Videos

Carisbamate (RWJ-333369).

Gerald P Novak1, Michael Kelley, Peter Zannikos

  • 1Johnson & Johnson, Pharmaceutical Research & Development L.L.C., Titusville, New Jersey 08560, USA. GNovak1@PRDUS.JNJ.COM

Neurotherapeutics : the Journal of the American Society for Experimental Neurotherapeutics
|January 3, 2007
PubMed
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Carisbamate, a novel neuromodulator, shows potent anti-seizure effects in rodent models with minimal toxicity. Phase 2 trials indicate efficacy and good tolerability for partial onset seizures.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Drug Development

Background:

  • Carisbamate (RWJ-333369) is an investigational neuromodulator developed for neurological disorders.
  • It exhibits potent anticonvulsant activity in various rodent seizure models.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of Carisbamate.
  • To characterize its pharmacokinetic and metabolic profile.

Main Methods:

  • Nonclinical toxicological studies were conducted.
  • Pharmacokinetic and drug interaction studies were performed.
  • A Phase 2 clinical trial for partial onset seizures was completed.

Main Results:

  • Carisbamate demonstrated high potency in rodent seizure models at non-toxic doses.

Related Experiment Videos

  • Metabolism occurs primarily via glucuronidation and oxidation, with minimal CYP involvement.
  • Linear pharmacokinetics were observed; clearance is affected by carbamazepine and oral contraceptives.
  • Common adverse events include mild to moderate headaches, dizziness, and somnolence at higher doses.
  • The Phase 2 study showed efficacy and good tolerability for adjunctive use in partial onset seizures.

    • Conclusions:

    • Carisbamate is a potent neuromodulator with a favorable preclinical safety profile.
    • Its pharmacokinetic properties are relatively well-defined, with notable drug interactions.
    • Clinical studies suggest Carisbamate is a promising candidate for treating partial onset seizures.