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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01749423
First received: December 12, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 ] [ Designated as safety issue: No ]

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®

  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 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.

Criteria

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 ClinicalTrials.gov identifier: NCT01749423

Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014