Phase 2
N=218
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00440518 ↗Enrolled (actual)
218
Serious AEs
3.2%
Results posted
Sep 2009
Primary outcome: Primary: Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period — -1.4; -1.4; -1.6 Number of migraine headaches
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lacosamide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period |
-1.4; -1.4; -1.6 | — |
| SECONDARY Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period |
-1.3; -1.3; -1.7 | — |
| SECONDARY Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. |
26; 32; 29 | — |
| 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. |
27; 27; 33 | — |
| SECONDARY Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) |
-3.8; -4.3; -3.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00440518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.