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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Recruitment Status : Withdrawn (Enrollment criteria was too challenging and Investigators changed Institutions)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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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




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


Information from the National Library of Medicine

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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

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


Locations
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United States, Alabama
University of South Alabama Department of Neurology
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
University of South Alabama
Investigators
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Principal Investigator: J. I. Lopez, MD University of South Alabama Department of Neurology
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Responsible Party: University of South Alabama
ClinicalTrials.gov Identifier: NCT00777218    
Other Study ID Numbers: 07-185
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Keywords provided by University of South Alabama:
migraine
Additional relevant MeSH terms:
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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