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

UCB

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Other: Placebo; Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440518

SP0906

Details and patient eligibility

About

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.

Full 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).

Enrollment: 218 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

Lacosamide 100mg

Experimental group

Description:

100mg lacosamide

Treatment:

Drug: Lacosamide

Drug: Lacosamide

Lacosamide 300mg

Experimental group

Description:

300mg lacosamide

Treatment:

Drug: Lacosamide

Drug: Lacosamide