Back to resultsCognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Primary Purpose
Migraine
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
propranolol
zonisamide
topiramate
Sponsored by
About this trial
This is an interventional health services research trial for Migraine focused on measuring migraine
Eligibility Criteria
Inclusion Criteria:
- diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
- subjects must between the age of 8-17 (inclusive)
Exclusion Criteria:
- diagnosis of tension-type headache or cluster headache
Sites / Locations
- University of South Alabama Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Record if memory, repetition or recall was impaired by subject during specific time frame on medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT00777218
First Posted
October 21, 2008
Last Updated
December 15, 2020
Sponsor
University of South Alabama
1. Study Identification
Unique Protocol Identification Number
NCT00777218
Brief Title
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Official Title
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Enrollment criteria was too challenging and Investigators changed Institutions
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Alabama
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
propranolol
Other Intervention Name(s)
Inderal
Intervention Description
standard pediatric doses, based on body weight
Intervention Type
Drug
Intervention Name(s)
zonisamide
Other Intervention Name(s)
Zonegran
Intervention Description
standard pediatric dosages, based on body weight
Intervention Type
Drug
Intervention Name(s)
topiramate
Other Intervention Name(s)
Topamax
Intervention Description
standard pediatric dosages, based on body weight
Primary Outcome Measure Information:
Title
Record if memory, repetition or recall was impaired by subject during specific time frame on medication.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
subjects must between the age of 8-17 (inclusive)
Exclusion Criteria:
diagnosis of tension-type headache or cluster headache
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. I. Lopez, MD
Organizational Affiliation
University of South Alabama Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Department of Neurology
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
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