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A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

NCT01662492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2017-09-05

Study results available
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Summary

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Conditions

  • Migraine Disorders

Interventions

BIOLOGICAL

Botulinum toxin type A Dose 1

Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.

BIOLOGICAL

Botulinum toxin type A Dose 2

Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.

DRUG

Placebo (Normal Saline)

Placebo (Normal Saline) intramuscular injections into specified muscles.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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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 NCT01662492 on ClinicalTrials.gov