Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
- Conditions
- Chronic Migraine
- Interventions
- Biological: OnabotulinumtoxinADrug: Normal saline (placebo)
- Registration Number
- NCT01833130
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OnabotulinumtoxinA OnabotulinumtoxinA OnabotulinumtoxinA (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. Placebo (Normal saline) Normal saline (placebo) Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score Baseline, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire Baseline, Week 24 The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.
Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire Baseline, Week 24 The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire Baseline, Week 12, Week 22, Week 24 The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.
Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score Baseline, Week 24 The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) Baseline, Week 24 The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.
Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ Baseline, Week 24 The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.
Change From Baseline in the Emotional Function (EF) Domain of the MSQ Baseline, Week 24 The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.