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

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

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  1. 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

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 • methysergide (withdrawn) • antidepressants • tricyclic antidepressants

  3. 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.

  4. 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.

  5. Study Population

  6. Demographics

  7. Safety and Tolerability

  8. Discontinuations due to AEs

  9. Maximum Tolerated Dose

  10. IsocarboxazidDoses in Study

  11. Other Treatment Emergent AEs

  12. Efficacy

  13. Average Migraine Frequency (Completers)

  14. Responders

  15. Observed Cases and LOCF

  16. 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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