BOTOX® Prophylaxis in Patients With Chronic Migraine

This study is currently recruiting participants.

Verified March 2012 by Allergan

First Received on September 9, 2011. Last Updated on March 12, 2012 History of Changes

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01432379

Purpose

This is a postauthorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.

Condition	Intervention
Migraine Disorders	Biological: botulinum toxin Type A

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Botox Headache Migraine

Drug Information available for: Onaclostox

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Incidence of Dysphagia [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of Worsening or Intractable Migraine [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 botulinum toxin Type A	Biological: botulinum toxin Type A 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year Other Name: BOTOX®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Chronic Migraine

Criteria

Inclusion Criteria:

Diagnosis of chronic migraine
Willing to use BOTOX® as preventative treatment for migraine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432379

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

United Kingdom
	Recruiting
London, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01432379 History of Changes
Other Study ID Numbers:	191622-110
Study First Received:	September 9, 2011
Last Updated:	March 12, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012