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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749410
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment
Chronic Migraine, Headaches Biological: onabotulinumtoxinA

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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®

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749410

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

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Responsible Party: Allergan Identifier: NCT01749410    
Other Study ID Numbers: GMA-BTX-CM-12-491
First Posted: December 13, 2012    Key Record Dates
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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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
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents