Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

• ClinicalTrials.gov Identifier: NCT00777218
• Recruitment Status: Withdrawn
• First Posted: October 22, 2008
• Last Update Posted: December 17, 2020
• Sponsor: University of South Alabama
• Information provided by (Responsible Party): University of South Alabama

Tracking Information

• First Submitted Date: October 21, 2008
• First Posted Date: October 22, 2008
• Last Update Posted Date: December 17, 2020
• Study Start Date: August 2007
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Migraine

Intervention

• 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

• Active Comparator: 1
  Intervention: Drug: propranolol
• Active Comparator: 2
  Intervention: Drug: zonisamide
• Active Comparator: 3
  Intervention: Drug: topiramate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 15, 2020): 0
• Original Estimated Enrollment (submitted: October 21, 2008): 90
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00777218
• Other Study ID Numbers: 07-185
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of South Alabama
• Study Sponsor: University of South Alabama
• Collaborators: Not Provided

Investigators

• Principal Investigator: J. I. Lopez, MD; University of South Alabama Department of Neurology

• PRS Account: University of South Alabama
• Verification Date: December 2020