MigrainePhase 2SP906NCT00440518

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

A Phase 2 study testing Lacosamide in people with Migraine, run by UCB Pharma at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine
What is being tested?: Lacosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 218 participants
Where: 24 sitesUnited States
Study dates: Feb 2007to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Study site
Albany, New York, 12205
Study site
Alexandria, Virginia
Study site
Ann Arbor, Michigan, 48104
Study site
Boulder, Colorado, 80304
Study site
Cleveland, Ohio, 44121
Study site
Conyers, Georgia, 30094
Study site
Evansville, Indiana
Study site
Greensboro, North Carolina, 27401
Study site
Houston, Texas, 77004
Study site
Huntsville, Alabama, 35801
Study site
Little Rock, Arkansas, 72205
Study site
Matthews, North Carolina, 28105
Study site
Nashville, Tennessee, 37203
Study site
Oklahoma City, Oklahoma
Study site
Palm Beach Gardens, Florida, 33410
Study site
San Antonio, Texas, 78258
Study site
Seattle, Washington, 98122
Study site
South Miami, Florida, 33143
Study site
Springfield, Missouri, 65807
Study site
St Louis, Missouri, 63141
Study site
Sunrise, Florida, 33351
Study site
Walnut Creek, California
Study site
Wellesley Hills, Massachusetts, 02481
Study site
Worcester, Massachusetts, 01605

Other trials in United States

About this study

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.

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.

Read the 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).

Conditions: Migraine
Being tested: Lacosamide, Placebo
Keywords: Lacosamide, migraine prophylaxis, Vimpat
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LacosamideDrug
Also called LCM, Vimpat
Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
PlaceboOther
Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
LacosamideDrug
Also called LCM, Vimpat
Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.

Study groups in NCT00440518
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Other: Placebo
Lacosamide 100mg	Experimental	100mg lacosamide Receives: Drug: Lacosamide
Lacosamide 300mg	Experimental	300mg lacosamide Receives: Drug: Lacosamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, last visit in the 17-week Trial Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Jul 2008

First posted27 Feb 2007 (estimated)
Study startFeb 2007
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00440518
Sponsor's protocol ID: SP0906
Acronym: SP906
Status last verified: Jul 2017
First submitted: 23 Feb 2007
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00440518
Acronym / sponsor ID: SP906 / SP0906
Conditions: Migraine
Keywords: Lacosamide, migraine prophylaxis, Vimpat
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 27 Feb 2007 (estimated)
Results: Posted 11 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboPlacebo
Lacosamide 100mg	Experimental	Drug: Lacosamide100mg lacosamide
Lacosamide 300mg	Experimental	Drug: Lacosamide300mg lacosamide

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LacosamideAlso: LCM, VimpatLacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart	Drug	Lacosamide 100mg
PlaceboImmediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart	Other	Placebo
LacosamideAlso: LCM, VimpatLacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.	Drug	Lacosamide 300mg

Primary outcome

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

4 secondary outcomes

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
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
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
Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
Time frame: Baseline, last visit in the 17-week Trial Period

Results and safety

Results posted to the registry on 11 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	72	59
Lacosamide 100mg	72	63
Lacosamide 300mg	74	70

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

Time frame: Baseline, Entire 14-week Maintenance Period. Mean (Standard Deviation). Unit: Number of migraine headaches

Measure	Placebo n = 71	Lacosamide 100mg n = 70	Lacosamide 300mg n = 74
Value	-1.4 (3.12)	-1.4 (2.68)	-1.6 (2.10)

Population analysed: Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 72 (4.2%)	30 of 72 (41.7%)	Not reported
Lacosamide 100mg	2 of 72 (2.8%)	36 of 72 (50%)	Not reported
Lacosamide 300mg	2 of 74 (2.7%)	33 of 74 (44.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Migraine, run by UCB Pharma at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period (time frame: Baseline, Entire 14-week Maintenance Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.