Status:
COMPLETED
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Lead Sponsor:
UCB Pharma
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00440518
Start Date
February 1 2007
End Date
July 1 2008
Last Update
July 17 2018
Active Locations (24)
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1
Huntsville, Alabama, United States, 35801
2
Little Rock, Arkansas, United States, 72205
3
Walnut Creek, California, United States
4
Boulder, Colorado, United States, 80304