Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

Study Overview
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Brief Summary
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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.

Conditions
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Chronic Migraine

Intervention / Treatment
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* Biological: OnabotulinumtoxinA
* Drug: Normal saline (placebo)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OnabotulinumtoxinA<br>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. | Biological: OnabotulinumtoxinA<br>* OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.<br>* Other names: BOTOX®;|
| Placebo Comparator: Placebo (Normal saline)<br>Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. | Drug: Normal saline (placebo)<br>* Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score | 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. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire | 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. | Baseline, Week 24 | 
| Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire | 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. | Baseline, Week 24 | 
| Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire | 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. | Baseline, Week 12, Week 22, Week 24 | 
| Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score | 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. | Baseline, Week 24 | 
| Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) | 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. | Baseline, Week 24 | 
| Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ | 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. | Baseline, Week 24 | 
| Change From Baseline in the Emotional Function (EF) Domain of the MSQ | 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. | Baseline, Week 24 |