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The Childhood and Adolescent Migraine Prevention Study

NCT01581281 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2017-08-10

Study results available
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Summary

The purpose of this research study is to test two medicines for migraine prevention in children and adolescents.

Conditions

Interventions

DRUG

Amitriptyline

Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.

DRUG

Topiramate

Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based.

DRUG

Placebo

Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Scott W. Powers, PhD · Children's Hospital Medical Center, Cincinnati

  • Andrew D. Hershey, MD, PhD · Children's Hospital Medical Center, Cincinnati

  • Christopher S. Coffey, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-04-30
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581281 on ClinicalTrials.gov