NCT01976611

Brief Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.7 years

First QC Date

October 30, 2013

Last Update Submit

April 7, 2015

Conditions

Migraine DisordersHeadache

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Adverse Events and Adverse Drug Reactions

    4 Years

  • Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale

    4 Years

Study Arms (1)

BOTOX®

Patients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice.

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type ABIOLOGICAL

Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.

BOTOX®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

You may qualify if:

  • Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

KR(1)