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

NCT01122381 | Terminated Phase 1 Results DMC

• 1 other identifier: B5043-R
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Headache, Migraine

Keywords

headache, migraine; depression; disability evaluation; weight gain

Outcome Measures

Primary Outcomes (1)

• Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week 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.

  4 weeks, end of treatment and pre-treatment baseline

Study Arms (2)

Arm 1-ethosuximide

EXPERIMENTAL

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

Drug: ethosuximide

Arm 2-placebo comparator

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

Interventions

ethosuximide DRUG

ethosuximide (ESX)

Also known as: zarontin

Arm 1-ethosuximide

placebo comparator OTHER

placebo

Arm 2-placebo comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a veteran.
• The number of migraine days per 4-week period is to be 4-14 for a period of 3 months prior to screening for entry into the trial.
• Migraine must have been occurring for 6 months preceding entry into the trial and age of onset should be before age 60 years.
• Migraine must be at least moderate severity and interrupt daily activities in some respect at least 3 times per month.

You may not qualify if:

• Migraine diagnosis:
• Veterans with headache must have migraine categorized using the International Headache Society (I.H.S.) criteria as illustrated below for the two main types with and without aura.
• Criteria for migraine without aura (I.H.S. 1.1)
• \> 5 attacks
• headache lasting 4-72 hours when untreated or not successfully treated.
• headache with two of the following characteristics
• unilateral,
• pulsating,
• moderate to severe intensity,
• aggravation by exertion.
• one of the following occurs with headache
• nausea and/or vomiting
• photophobia and phonophobia
• Criteria for migraine with aura (I.H.S. 1.2)
• at least 2 attacks

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Thomas Jefferson University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Depression; Weight Gain

Interventions

Ethosuximide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Succinimides; Imides; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination occurred due to inadequate recruitment of episodic migraineurs in a population meeting too many exclusion criteria; resulting in no subjects available for analysis.

Results Point of Contact

• Title: Kathy Gardner MD
• Organization: Vetarans Administration Pittsburgh Healthcare System

kathy.gardner@va.gov

(412) 360-6185

Study Officials

• Kathy L Gardner, MD

  VA Pittsburgh Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 13, 2010
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 19, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-08

Locations

US (1)