A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01749410
First received: December 12, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine Headache patients who have received a minimum of 7 treatment cycles.


Condition Intervention
Chronic Migraine, Headaches
Biological: onabotulinumtoxinA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Headache Days [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Biological: onabotulinumtoxinA
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Other Names:
  • botulinum toxin Type A
  • BOTOX®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraines.

Criteria

Inclusion Criteria:

  • 15 or more headache days over a 30 day period
  • A minimum of 7 treatment cycles with onabotulinumtoxinA

Exclusion Criteria:

  • Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749410

Locations
United States, New York
Buffalo, New York, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01749410     History of Changes
Other Study ID Numbers: GMA-BTX-CM-12-491
Study First Received: December 12, 2012
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central 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 April 17, 2014