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

Chronic Migraine, Headache Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01749423
• Other study ID #: GMA-BTX-CM-12-518
• Status: Withdrawn
• Phase: N/A
• First received: December 12, 2012
• Last updated: January 31, 2014
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Biological:
• OnabotulinumtoxinA
Previous treatment with onabotulinumtoxinA for Chronic Migraine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Headache Days		Up to 56 Weeks	No