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Completed

NCT Number: NCT00440518

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huntsville, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lacosamide

Drug

Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart

Other names: LCM, Vimpat

Placebo

Other

Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart

Primary outcomes

  1. Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period

    Time frame: Baseline, Entire 14-week Maintenance Period

Secondary outcomes

  1. Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period

    Time frame: Baseline, last 4 weeks of the 14-week Maintenance Period

  2. Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.

    Time frame: Baseline, Entire 14-week Maintenance Period

  3. Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.

    Time frame: Baseline, last 4 weeks of the 14-week Maintenance Period

  4. Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)

    Time frame: Baseline, last visit in the 17-week Trial Period

    Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.

Acronym: SP906

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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