Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
|ClinicalTrials.gov Identifier: NCT01122381|
Recruitment Status : Terminated (poor recruitment)
First Posted : May 13, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Headache, Migraine||Drug: ethosuximide Other: placebo comparator||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacologic and Genetic Evaluation of a C. Elegans Model for Migraine|
|Study Start Date :||December 2011|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Experimental: Arm 1-ethosuximide
ethosuximide blinded capsules of 250mg ESX; titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability
Other Name: zarontin
Placebo Comparator: Arm 2-placebo comparator
placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability
Other: placebo comparator
- Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline. [ Time Frame: 4 weeks, end of treatment and pre-treatment baseline ]
Compare number of migraine headache days pre and post treatment between the ESX and placebo group.
Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122381
|United States, Pennsylvania|
|VA Pittsburgh Health Care System|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Kathy L Gardner, MD||VA Pittsburgh Health Care System|