MedTrace Logo

A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches

NCT00203216 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-08-11

Study results available
· View outcomes & findings →

Summary

The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug.

The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances).

In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.

Conditions

Interventions

DRUG

levetiracetam

Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)

PROCEDURE

Transcranial Magnetic Stimulation

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • William B Young, MD · Thomas Jefferson University, Jefferson Headache Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2005-01-31
Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00203216 on ClinicalTrials.gov