Comparison of a Drug and Placebo in the Prevention of Migraine Headaches

This study has been terminated.
(poor recruitment)
Sponsor:
Collaborators:
Thomas Jefferson University
University of Pittsburgh
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01122381
First received: May 10, 2010
Last updated: August 11, 2015
Last verified: August 2015
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Headache, Migraine
Interventions: Drug: ethosuximide
Other: placebo comparator

  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

Primary Care and Neurology Clinic prescreening and recruitment from VA Pittsburgh hospitals during the following periods:

1/14/11-4/1/11; 1/14/12-3/19/12; 2/4/13-3/12/14. Average prescreening of datawarehouse records for eligibility = 2954 subjects/month.

Average prescreening electronic chart review for eligibility = 265 subjects/month.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 consented. Initial 4 week baseline period uses headache diary to confirm headache days prior to randomization. 3/5 enrollees did not begin baseline phase; 1 lost to f/u, 1 dis-enrolled due to study interruption, 1 dis-enrolled shortly after consent when another physician began a study excluded drug. 2 enrollees did complete baseline phase.

Reporting Groups
  Description
Arm 1-drug Treatment

migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria

ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability

Arm 2-placebo

migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria

placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability


Participant Flow:   Overall Study
    Arm 1-drug Treatment     Arm 2-placebo  
STARTED     1     1  
COMPLETED     1 [1]   0  
NOT COMPLETED     0     1  
study terminated early                 0                 1  
[1] Subject never took the drug per review of ESX levels after unblinding



  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.
Enrollees who completed baseline period and randomization.

Reporting Groups
  Description
Arm 1

migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria

ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability

Arm 2

placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability

placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     0     1  
Male     0     1     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     1     1     2  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     1     1     2  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     1     1     2  



  Outcome Measures

1.  Primary:   Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.   [ Time Frame: 4 weeks, end of treatment and pre-treatment baseline ]


  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
Early termination occurred due to inadequate recruitment of episodic migraineurs in a population meeting too many exclusion criteria; resulting in no subjects available for analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathy Gardner MD
Organization: Vetarans Administration Pittsburgh Healthcare System
phone: (412) 360-6185
e-mail: kathy.gardner@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01122381     History of Changes
Other Study ID Numbers: B5043-R
Study First Received: May 10, 2010
Results First Received: June 5, 2015
Last Updated: August 11, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration