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

NCT01749423 | Withdrawn

• 1 other identifier: GMA-BTX-CM-12-518
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

• Number of Headache Days

  Up to 56 Weeks

Study Arms (1)

All participants

Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective review of medical records.

Biological: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA BIOLOGICAL

Previous treatment with onabotulinumtoxinA for Chronic Migraine.

Also known as: botulinum toxin Type A, BOTOX®

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• History of chronic migraines
• 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

You may not qualify if:

• Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

Sponsors & Collaborators

• Allergan: lead

MeSH Terms

Conditions

Headache

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 13, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01