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: August 14, 2014
Last verified: August 2014
  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: 37
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749410

Locations
United States, California
Encinitas, California, 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: August 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014