MedTrace Logo

A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

NCT01516892 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 716

Last updated 2017-01-06

Study results available
· View outcomes & findings →

Summary

This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Conditions

  • Migraine Disorders

Interventions

BIOLOGICAL

onabotulinumtoxinA

Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Australia
  • South Korea

Study Locations

More Related Trials

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 NCT01516892 on ClinicalTrials.gov