Clinical trial NCT01833130: Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Migraine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* History of chronic migraine for at least 6 months prior to the screening visit
* Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion Criteria:

* Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
* Use of headache prophylaxis medication within 4 weeks of the screening visit
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Previous use of any botulinum toxin of any serotype for any reason
* Skin infections or acne that would interfere with the injection sites
* 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.

Primary outcomes:
measure: Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire
timeFrame: Baseline, Week 12, Week 22, Week 24
measure: Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Emotional Function (EF) Domain of the MSQ
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: