Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

NCT00777218 | Withdrawn

• 1 other identifier: 07-185
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine

Outcome Measures

Primary Outcomes (1)

• Record if memory, repetition or recall was impaired by subject during specific time frame on medication.

  3 months

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: propranolol

2

ACTIVE COMPARATOR

Drug: zonisamide

3

ACTIVE COMPARATOR

Drug: topiramate

Interventions

propranolol DRUG

standard pediatric doses, based on body weight

Also known as: Inderal

1

zonisamide DRUG

standard pediatric dosages, based on body weight

Also known as: Zonegran

2

topiramate DRUG

standard pediatric dosages, based on body weight

Also known as: Topamax

3

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
• subjects must between the age of 8-17 (inclusive)

You may not qualify if:

• diagnosis of tension-type headache or cluster headache

Sponsors & Collaborators

• University of South Alabama: lead

Study Sites (1)

University of South Alabama Department of Neurology

Mobile, Alabama, 36693, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Propranolol; Zonisamide; Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• J. I. Lopez, MD

  University of South Alabama Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)