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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203216
First received: September 13, 2005
Last updated: July 15, 2011
Last verified: July 2011
Results First Received: May 23, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: levetiracetam
Procedure: Transcranial Magnetic Stimulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Levetiracetam/Transcranial Magnetic Stimulation 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.

Participant Flow:   Overall Study
    Levetiracetam/Transcranial Magnetic Stimulation  
STARTED     31  
COMPLETED     27  
NOT COMPLETED     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Levetiracetam/Transcranial Magnetic Stimulation 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.

Baseline Measures
    Levetiracetam/Transcranial Magnetic Stimulation  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  39  ± 12.47  
Gender  
[units: participants]
 
Female     26  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures

1.  Primary:   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). ]

2.  Secondary:   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. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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 not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: William.B.Young@Jefferson.Edu


No publications provided


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
Study First Received: September 13, 2005
Results First Received: May 23, 2011
Last Updated: July 15, 2011
Health Authority: United States: Food and Drug Administration