A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.

• Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.

• On effective stable abortive medication(s) for the acute treatment of migraine.

Exclusion Criteria:

• Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.

• Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening.

• Experience 15 or more headache days per month of any kind 2 months prior to screening.

• Has another consistent or chronic form of headache.

• Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.

• Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.

• Significant laboratory or electrocardiograms (ECG) abnormalities

• Significant medical history including cardiovascular abnormalities.