Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777218
Recruitment Status : Unknown
Verified June 2010 by University of South Alabama.
Recruitment status was:  Recruiting
First Posted : October 22, 2008
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
University of South Alabama

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: propranolol Drug: zonisamide Drug: topiramate Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
Study Start Date : August 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1 Drug: propranolol
standard pediatric doses, based on body weight
Other Name: Inderal
Active Comparator: 2 Drug: zonisamide
standard pediatric dosages, based on body weight
Other Name: Zonegran
Active Comparator: 3 Drug: topiramate
standard pediatric dosages, based on body weight
Other Name: Topamax


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Record if memory, repetition or recall was impaired by subject during specific time frame on medication. [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777218


Contacts
Layout table for location contacts
Contact: J. I. Lopez, MD 251-665-8375 ilopez@usouthal.edu
Contact: Naomi S Walters 251-660-5506 nwalters@usouthal.edu

Locations
Layout table for location information
United States, Alabama
University of South Alabama Department of Neurology Recruiting
Mobile, Alabama, United States, 36693
Sub-Investigator: Maher Loutfi, MD         
Sponsors and Collaborators
University of South Alabama
Investigators
Layout table for investigator information
Principal Investigator: J. I. Lopez, MD University of South Alabama Department of Neurology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: J. Ivan Lopez, MD, Associate Professor of Neurology, University of South Alabama Department of Neurology
ClinicalTrials.gov Identifier: NCT00777218    
Other Study ID Numbers: 07-185
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: June 2010
Keywords provided by University of South Alabama:
migraine
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Propranolol
Zonisamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Anticonvulsants
Hypoglycemic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents