A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00440518
First received: February 23, 2007
Last updated: September 19, 2014
Last verified: September 2011

February 23, 2007
September 19, 2014
February 2007
July 2008   (final data collection date for primary outcome measure)
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period [ Time Frame: Baseline, Entire 14-week Maintenance Period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00440518 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
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Not Provided
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A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day 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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Migraine
  • Drug: Lacosamide
    Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
    Other Names:
    • LCM
    • Vimpat
  • Other: Placebo
    Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
  • Drug: Lacosamide
    Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
    Other Names:
    • LCM
    • Vimpat
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • Experimental: Lacosamide 100mg
    100mg lacosamide
    Intervention: Drug: Lacosamide
  • Experimental: Lacosamide 300mg
    300mg lacosamide
    Intervention: Drug: Lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440518
SP0906
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP