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Herbert Harris, MD, PhD Validus Pharmaceuticals, Parsippany, New Jersey Bruce Corser, MD

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Safety and Tolerability of the MAO Inhibitor Isocarboxazid (Marplan) in the prophylactic treatment of migraine*. Herbert Harris, MD, PhD Validus Pharmaceuticals, Parsippany, New Jersey Bruce Corser, MD Community Research, Cincinnati, Ohio Richard A Guarino, MD

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Safety and Tolerability of the MAO Inhibitor Isocarboxazid (Marplan) in the prophylactic treatment of migraine*
  • Herbert Harris, MD, PhD
    • Validus Pharmaceuticals, Parsippany, New Jersey
  • Bruce Corser, MD
    • Community Research, Cincinnati, Ohio
  • Richard A Guarino, MD
    • Oxford Pharmaceutical Services, Totowa, New Jersey

* Study funded by Validus Pharmaceuticals

migraine prophylaxis
Migraine prophylaxis
  • antiepileptic agents
    • topiramate and divalproex
  • beta-adrenergic blockers
    • propranolol and timolol.
  • methysergide (withdrawn)
  • antidepressants
    • tricyclic antidepressants
objective

Objective

The purpose of this open-label pilot study was to evaluate the safety and tolerability of the MAOI Isocarboxazid (Marplan) in the prophylactic treatment of migraine.

methods
Methods
  • Male and female subjects 18-60 years of age
  • Diagnosis of migraine according to IHS criteria
  • 3-12 HAs per month for the 3 months prior to screening
  • Isocarboxazid (Marplan) treatment was initiated at 20mg per day and increased as tolerated to a maximum dose of 60mg per day
  • Treatment covered three months
  • Concomitant use of tryptans, NSAIDs antidepressants and other commonly used anti-migraine agents was prohibited
  • The primary efficacy measure was within-subject change from baseline in migraine frequency.
conclusions
Conclusions
  • The tolerability of Isocarboxazid (Marplan) in this study was similar to that reported in depression trials
    • Insomnia, irritability, and sexual dysfunction were the most common adverse events
    • Five subjects (31%) withdrew due to adverse events
    • No serious adverse events were reported
  • In this small open-label study, Isocarboxazid (Marplan) showed very robust clinical efficacy in the prophylactic treatment of migraine attacks
  • Isocarboxazid offers a mechanistically novel approach to migraine prophylaxis that warrants further investigation.
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