Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines

This study has been withdrawn prior to enrollment.
(Company decision due to enrollment challenges.)
Information provided by (Responsible Party):
Allergan Identifier:
First received: December 12, 2012
Last updated: January 31, 2014
Last verified: January 2014
This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.

Condition Intervention
Chronic Migraine, Headache
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 56 Weeks ]

Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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 review of medical records.
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 with chronic migraines who received a minimum of two consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of two consecutive treatment cycles with the OnabotulinumtoxinA dosing between 155 and 195 units.

Inclusion Criteria:

  • History of chronic migraines
  • 15 or more headache days over a 30 day period
  • A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units

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 identifier: NCT01749423

Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan Identifier: NCT01749423     History of Changes
Other Study ID Numbers: GMA-BTX-CM-12-518
Study First Received: December 12, 2012
Last Updated: January 31, 2014

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 May 25, 2017