Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

This study is currently recruiting participants.

Verified June 2010 by University of South Alabama

First Received on October 21, 2008. Last Updated on June 23, 2010 History of Changes

Sponsor:	University of South Alabama
Information provided by:	University of South Alabama
ClinicalTrials.gov Identifier:	NCT00777218

Purpose

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	Intervention
Migraine	Drug: propranolol Drug: zonisamide Drug: topiramate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Memory Migraine

Drug Information available for: Zonisamide Topiramate Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by University of South Alabama:

Primary Outcome Measures:

Record if memory, repetition or recall was impaired by subject during specific time frame on medication. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777218

Contacts

Contact: J. I. Lopez, MD	251-665-8375	ilopez@usouthal.edu
Contact: Naomi S Walters	251-660-5506	nwalters@usouthal.edu

Locations

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

Principal Investigator:

J. I. Lopez, MD

University of South Alabama Department of Neurology

More Information

No publications provided

Responsible Party:	J. Ivan Lopez, MD, Associate Professor of Neurology, University of South Alabama Department of Neurology
ClinicalTrials.gov Identifier:	NCT00777218 History of Changes
Other Study ID Numbers:	07-185
Study First Received:	October 21, 2008
Last Updated:	June 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Alabama:

migraine

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Propranolol
Topiramate
Zonisamide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents
Antioxidants

ClinicalTrials.gov processed this record on February 09, 2012