Completed
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
What is being tested
OnabotulinumtoxinA
+ Normal saline (placebo)
BiologicalDrug
Who is being recruted
From 18 to 65 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 4
Interventional
Study Start: April 2013
Summary
Principal SponsorAllergan
Last updated: October 21, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.
Principal SponsorAllergan
Last updated: October 21, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
52 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
Fifteen or more headache days during the 4-week screening period ( >= 4 headache episodes lasting >= 4 hours and >= 50 % of headache days are migraine)
History of chronic migraine for at least 6 months prior to the screening visit
6 exclusion criteria prevent from participating
Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening
Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Previous use of any botulinum toxin of any serotype for any reason
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalOnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Group II
PlaceboPlacebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
San Francisco, United StatesOpen in Google Maps
CompletedOne Study Center