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Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

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ClinicalTrials.gov Identifier: NCT00777218
Recruitment Status : Withdrawn (Enrollment criteria was too challenging and Investigators changed Institutions)
First Posted : October 22, 2008
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of South Alabama

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date December 17, 2020
Study Start Date  ICMJE August 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Record if memory, repetition or recall was impaired by subject during specific time frame on medication. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Official Title  ICMJE Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: propranolol
    standard pediatric doses, based on body weight
    Other Name: Inderal
  • Drug: zonisamide
    standard pediatric dosages, based on body weight
    Other Name: Zonegran
  • Drug: topiramate
    standard pediatric dosages, based on body weight
    Other Name: Topamax
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: propranolol
  • Active Comparator: 2
    Intervention: Drug: zonisamide
  • Active Comparator: 3
    Intervention: Drug: topiramate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 15, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
90
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777218
Other Study ID Numbers  ICMJE 07-185
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Alabama
Study Sponsor  ICMJE University of South Alabama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J. I. Lopez, MD University of South Alabama Department of Neurology
PRS Account University of South Alabama
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP