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A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches

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ClinicalTrials.gov Identifier: NCT00203216
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: levetiracetam
Procedure: Transcranial Magnetic Stimulation
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levetiracetam/Transcranial Magnetic Stimulation
Hide Arm/Group Description In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Period Title: Overall Study
Started 31
Completed 27
Not Completed 4
Arm/Group Title Levetiracetam/Transcranial Magnetic Stimulation
Hide Arm/Group Description In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
39  (12.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
26
  83.9%
Male
5
  16.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levetiracetam/Transcranial Magnetic Stimulation
Hide Arm/Group Description:
In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: migraine attacks per month
-0.058  (5.10)
2.Secondary Outcome
Title 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.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Baseline period compared to 28 day interval prior to Visit 4-7.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levetiracetam/Transcranial Magnetic Stimulation
Hide Arm/Group Description In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
All-Cause Mortality
Levetiracetam/Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam/Transcranial Magnetic Stimulation
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levetiracetam/Transcranial Magnetic Stimulation
Affected / at Risk (%) # Events
Total   21/31 (67.74%)    
Nervous system disorders   
fatigue  21/31 (67.74%)  21
Irritability  16/31 (51.61%)  16
Dizziness  13/31 (41.94%)  13
Psychiatric disorders   
Labile mood  6/31 (19.35%)  6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. William Young, Principal Investigator
Organization: Thomas Jefferson University/Jefferson Headache Center
Phone: 215-955-2243
Responsible Party: William B. Young, M.D.-Principal Investigator, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203216     History of Changes
Other Study ID Numbers: WBY/LEV01
080-19000-H80001
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: May 23, 2011
Results First Posted: August 11, 2011
Last Update Posted: August 11, 2011