NCT00440518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 11, 2009

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

February 23, 2007

Results QC Date

August 3, 2009

Last Update Submit

June 20, 2018

Conditions

Migraine

Keywords

Lacosamidemigraine prophylaxisVimpat

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Entire 14-week Maintenance Period

Secondary Outcomes (4)

  • 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

  • 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

  • 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

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

    Baseline, last visit in the 17-week Trial Period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Lacosamide 100mg

EXPERIMENTAL

100mg lacosamide

Drug: Lacosamide

Lacosamide 300mg

EXPERIMENTAL

300mg lacosamide

Drug: Lacosamide

Interventions

LacosamideDRUG

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

Also known as: LCM, Vimpat
Lacosamide 100mg
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Boulder, Colorado, 80304, United States

Location

Unknown Facility

Palm Beach Gardens, Florida, 33410, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Sunrise, Florida, 33351, United States

Location

Unknown Facility

Conyers, Georgia, 30094, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Wellesley Hills, Massachusetts, 02481, United States

Location

Unknown Facility

Worcester, Massachusetts, 01605, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48104, United States

Location

Unknown Facility

Springfield, Missouri, 65807, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Albany, New York, 12205, United States

Location

Unknown Facility

Greensboro, North Carolina, 27401, United States

Location

Unknown Facility

Matthews, North Carolina, 28105, United States

Location

Unknown Facility

Cleveland, Ohio, 44121, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

Unknown Facility

San Antonio, Texas, 78258, United States

Location

Unknown Facility

Alexandria, Virginia, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Results Point of Contact

Title
Study Director
Organization
UCB Clinical Trial Call Center
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 27, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 17, 2018

Results First Posted

September 11, 2009

Record last verified: 2017-07

Locations

US(24)