Status:
COMPLETED
A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
UCB Pharma
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00203216
Start Date
September 1 2002
End Date
September 1 2005
Last Update
August 11 2011
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107