Safety and Tolerability of the MAO Inhibitor Isocarboxazid (Marplan) in the prophylactic treatment o...
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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 (Marplan) in the prophylactic treatment of migraine*

  • antiepileptic agents

    • topiramate and divalproex

  • beta-adrenergic blockers

    • propranolol and timolol.

  • methysergide (withdrawn)

  • antidepressants

    • tricyclic antidepressants


Objective

Objective (Marplan) in the prophylactic treatment of migraine*

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 (Marplan) in the prophylactic treatment of migraine*

  • 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.


Study population
Study Population (Marplan) in the prophylactic treatment of migraine*


Demographics
Demographics (Marplan) in the prophylactic treatment of migraine*


Safety and tolerability
Safety and Tolerability (Marplan) in the prophylactic treatment of migraine*


Discontinuations due to aes
Discontinuations due to AEs (Marplan) in the prophylactic treatment of migraine*


Maximum tolerated dose
Maximum Tolerated Dose (Marplan) in the prophylactic treatment of migraine*


Isocarboxazid doses in study
Isocarboxazid (Marplan) in the prophylactic treatment of migraine*Doses in Study


Other treatment emergent aes
Other Treatment Emergent AEs (Marplan) in the prophylactic treatment of migraine*


Efficacy
Efficacy (Marplan) in the prophylactic treatment of migraine*


Average migraine frequency completers
Average Migraine Frequency (Completers) (Marplan) in the prophylactic treatment of migraine*


Responders
Responders (Marplan) in the prophylactic treatment of migraine*


Observed cases and locf
Observed Cases and LOCF (Marplan) in the prophylactic treatment of migraine*


Conclusions
Conclusions (Marplan) in the prophylactic treatment of migraine*

  • 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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