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

Completed

• Conditions: Chronic Migraine, Headaches
• Interventions: Biological: onabotulinumtoxinA

• Registration Number: NCT01749410
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-08
• Results First Submitted: 2015-08-10
• Results First Submitted QC: 2015-08-10
• Last Update Submitted: 2015-08-10
• Results First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• 15 or more headache days over a 30 day period
• A minimum of 7 treatment cycles with onabotulinumtoxinA

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Exclusion Criteria

• Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	onabotulinumtoxinA	Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Headache Days	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.