NCT01122381

Comparison of a Drug and Placebo in the Prevention of Migraine Headaches

Pharmacologic and Genetic Evaluation of a C. Elegans Model for Migraine

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ethosuximide works better than placebo in the prevention of episodic migraine among veterans.

Detailed description

Chronic and episodic headaches in veteran populations include migraine, transformed migraine, and post-traumatic headache with migrainous features. More and better prophylactic drugs with fewer side effects (such as weight gain) are needed to treat these disabling, refractory conditions which generally have less than a 50% response rate to preventative treatments. Rare forms of severe familial hemiplegic migraine (FHM) are considered channelopathies and can be caused by mutations in a calcium channel gene. Serotonin is also known to be a critical neurotransmitter in migraine based on the pharmacology of acute and preventative treatments. We previously identified a "migraine" signaling pathway in an invertebrate C. elegans "hemiplegic migraine" model of a mutant calcium channel upstream from transforming growth factor-beta (TGF-beta) and showed that low serotonin levels can be rescued by treatment with the childhood antiepileptic drug ethosuximide (ESX). Objective: We propose to test our findings from this invertebrate migraine model to determine its relevance to humans in the prevention of episodic migraine. Primary Aim: Determine whether ethosuximide (ESX) will be significantly more effective than placebo in reducing migraine headache days. We propose a 3 year, double blind, phase 1/2 randomized, 2:1 ESX:placebo controlled parallel trial in episodic migraineurs comparing migraine headache days during the last 4 weeks of treatment to a pre-treatment 4 week baseline.

Conditions

• Headache, Migraine

Interventions

Type	Name	Description
DRUG	ethosuximide	ethosuximide (ESX)
OTHER	placebo comparator	placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-05-13
• Last updated: 2015-08-19
• Results posted: 2015-08-19

Locations

1 site across 1 country: United States