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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lacosamide
Placebo
Lacosamide
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Lacosamide, migraine prophylaxis, Vimpat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Lacosamide 100mg

Lacosamide 300mg

Arm Description

Placebo

100mg lacosamide

300mg lacosamide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the 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.
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.
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.

Full Information

First Posted
February 23, 2007
Last Updated
June 20, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00440518
Brief Title
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Lacosamide, migraine prophylaxis, Vimpat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Lacosamide 100mg
Arm Type
Experimental
Arm Description
100mg lacosamide
Arm Title
Lacosamide 300mg
Arm Type
Experimental
Arm Description
300mg lacosamide
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
LCM, Vimpat
Intervention Description
Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
LCM, Vimpat
Intervention Description
Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Time Frame
Baseline, Entire 14-week Maintenance Period
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
Description
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.
Time Frame
Baseline, last visit in the 17-week Trial Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
City
Alexandria
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

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

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