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

Migraine Clinical Trial

— SP906  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440518
• Other study ID #: SP0906
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period		Baseline, Entire 14-week Maintenance Period
Secondary	Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period		Baseline, last 4 weeks of the 14-week Maintenance Period
Secondary	Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.		Baseline, Entire 14-week Maintenance Period
Secondary	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.		Baseline, last 4 weeks of the 14-week Maintenance Period
Secondary	Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)	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.	Baseline, last visit in the 17-week Trial Period

External Links

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