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Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

NCT02191579 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2018-06-07

Study results available
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Summary

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Conditions

  • Migraine Disorders

Interventions

BIOLOGICAL

onabotulinumtoxinA

155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.

DRUG

Topiramate

Topiramate up to a maximum oral dose of 100 mg/day.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Esther Jo · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-05
Primary Completion
2017-05-09
Completion
2017-09-01
FDA Drug
Yes

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 NCT02191579 on ClinicalTrials.gov