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

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT00440518

Run by

UCB Pharma

People needed

218

Starts

2007-02-01

Expected to finish

2008-07-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Walnut Creek, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Sunrise, Florida, United States
• Study site — Conyers, Georgia, United States
• Study site — Evansville, Indiana, United States
• Study site — Wellesley Hills, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Springfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Albany, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Matthews, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Alexandria, Virginia, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.