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

This study has been completed.
Information provided by (Responsible Party):
Allergan Identifier:
First received: December 12, 2012
Last updated: August 10, 2015
Last verified: August 2015
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine 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:
  • Change From Baseline in the Number of Headache Days [ Time Frame: Treatment Cycle 7 (approximately 1.5 years) ]
    The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.

Enrollment: 33
Study Start Date: May 2013
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®


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 Migraine.

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
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Please refer to this study by its identifier: NCT01749410

United States, California
Encinitas, California, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan Identifier: NCT01749410     History of Changes
Other Study ID Numbers: GMA-BTX-CM-12-491
Study First Received: December 12, 2012
Results First Received: August 10, 2015
Last Updated: August 10, 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents processed this record on April 28, 2017