MigraineNCT00203216
A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches
A study testing levetiracetam and Transcranial Magnetic Stimulation in people with Migraine, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- levetiracetam and Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2005
- Phase
- Interventional
- 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
- Patient is male or female between the ages of 18 and 65
- Patient has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
- Patient has experienced between 4 and 10 migraine headaches per month over the past six months, with at least 48 hours separating attacks
- Patient is able to differentiate migraine attacks from other headache types, if applicable
- Patient is not currently and has not in the 4 weeks preceding screening received prophylactic treatment for the indication of migraine
- Patients daily medications have remained at a stable dose for the 4 weeks preceding screening
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- Patient is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
- Patient has negative urine pregnancy test prior to study entry, if female of child-bearing potential
- Patient is able to understand and comply with all study requirements
- Patient provides written informed consent prior to any screening procedures being conducted
Who cannot join
- Women who are pregnant or lactating
- Patients with onset of migraine after 50 years of age
- Patients who experience > 15 headache days per month
- Patients who have been previously treated or are currently being treated with levitiracetam
- Patients who have failed greater than 3 adequate trials of other antiepileptic drugs for the prevention of migraine.
- Patients who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
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- Patients with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
- Patients who take medication for acute treatment greater than 10 days per month over the past three months.
- Patients who are allergic to or have shown hypersensitivity to compounds similar to levetiracetam
- Patients with a history of significant drug or alcohol abuse within the past year
- Patients who have had a suicidal ideation in the 3 months prior to screening or has a history of attempted suicide
- Patients who currently have or have a history of significantly impaired renal function
- Patients who have participated in an investigational drug trial in the 30 days prior to the screening visit
- Patients who have a Beck Depression Inventory score of > 18 at screening
- Patients who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
- Patients who have a defibrillator or pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (e.g. a shrapnel wound).
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Single-Center, Open-Label Trial Examining the Efficacy and Safety of Levetiracetam for the Prophylactic Treatment of Migraine, With or Without Aura
The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug.
The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances).
In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.
- Conditions
- Migraine
- Being tested
- levetiracetam, Transcranial Magnetic Stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Also called Keppra
Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)
Transcranial Magnetic StimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Levatiracetam | Experimental | Subject titrated open-label study drug to maximally tolerated dose: maximum: 3000 mg. per date. (minimum allowed daily dose to remain in study: 1000) Receives: Drug: levetiracetam; Procedure: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:
- visit_4 = first follow-up interval (0 to 28 days after starting study drug)
- visit_5 = second follow-up interval (28 to 56 days)
- visit_6 = third follow-up interval (56 to 84 days)
- visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI
Measured: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).
Secondary outcomes (3)
Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:
- visit_4 = first follow-up interval (0 to 28 days after starting study drug)
- visit_5 = second follow-up interval (28 to 56 days)
- visit_6 = third follow-up interval (56 to 84 days)
- visit_7 = fourth follow-up interval (84 to 126 days)
Measured: Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.
Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Measured: Baseline period compared to 28 day interval prior to Visit 4-7.
Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Measured: Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionJan 2005
- Study completionSep 2005
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.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- William B Young, MD, Principal investigator, Thomas Jefferson University, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203216
- Sponsor's protocol ID
- WBY/LEV01
- Other IDs
- 080-19000-H80001
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 11 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Trial Examining the Efficacy and Safety of Levetiracetam for the Prophylactic Treatment of Migraine, With or Without Aura
- ClinicalTrials.gov ID
- NCT00203216
- Acronym / sponsor ID
- WBY/LEV01
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Sep 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 11 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug.
The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances).
In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levatiracetam | Experimental | Drug: levetiracetam, Procedure: Transcranial Magnetic StimulationSubject titrated open-label study drug to maximally tolerated dose: maximum: 3000 mg. per date. (minimum allowed daily dose to remain in study: 1000) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is male or female between the ages of 18 and 65
- Patient has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
- Patient has experienced between 4 and 10 migraine headaches per month over the past six months, with at least 48 hours separating attacks
- Patient is able to differentiate migraine attacks from other headache types, if applicable
- Patient is not currently and has not in the 4 weeks preceding screening received prophylactic treatment for the indication of migraine
Key exclusion criteria (16 listed)
- Women who are pregnant or lactating
- Patients with onset of migraine after 50 years of age
- Patients who experience > 15 headache days per month
- Patients who have been previously treated or are currently being treated with levitiracetam
- Patients who have failed greater than 3 adequate trials of other antiepileptic drugs for the prevention of migraine.
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 |
|---|---|---|
| levetiracetamAlso: KeppraDaily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg) | Drug | Levatiracetam |
| Transcranial Magnetic Stimulation | Procedure or surgery | Levatiracetam |
Primary outcome
The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Time frame: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).
Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit_4 = first follow-up interval (0 to 28 days after starting study drug) * visit_5 = second follow-up interval (28 to 56 days) * visit_6 = third follow-up interval (56 to 84 days) * visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI
3 secondary outcomes
Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Time frame: Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.
Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Time frame: Baseline period compared to 28 day interval prior to Visit 4-7.
Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Time frame: Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William B Young, MD principal investigator
Thomas Jefferson University, Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levetiracetam and Transcranial Magnetic Stimulation in people with Migraine, run by Thomas Jefferson University at 1 site 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 10 inclusion and 16 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 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2011). 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?
The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period. (time frame: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2011.