Phase 4
Completed N=52
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
Source: ClinicalTrials.gov NCT01833130 ↗Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score — 50.5; 47.2; -25.2; -20.5 Scores on a Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score |
50.5; 47.2; -25.2; -20.5 | — |
| SECONDARY Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire |
54.3; 45.9; -18.5; -17.5 | — |
| SECONDARY Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire |
8.4; 8.2; -1.6; -1.9 | — |
| SECONDARY Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire |
45; 43.3; -15.7; -15.3; -30.4; -18.7 | — |
| SECONDARY Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire |
51.9; 42.3; -20; -13.9; -26.7; -14.9 | — |
| SECONDARY Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire |
47.9; 43.1; -16.7; -20.5; -32.3; -16 | — |
| SECONDARY Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire |
39.6; 43.1; -9.8; -21.8; -19; -20 | — |
| SECONDARY Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire |
51.6; 55.4; -16; -25.3; -29.2; -22.7 | — |
| SECONDARY Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire |
45.3; 48.5; -17.3; -18.9; -27.7; -24 | — |
| SECONDARY Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire |
58.2; 60.2; -19.7; -22.4; -33.1; -20 | — |
| SECONDARY Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire |
60.0; 52.6; -25.2; -20.7; -31.1; -20.9 | — |
| SECONDARY Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire |
57.9; 53.1; -22.7; -18.9; -38.3; -10.7 | — |
| SECONDARY Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score |
64.7; 65.3; -5.1; -6.7 | — |
| SECONDARY Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) |
39.8; 40.9; 32.1; 26.5 | — |
| SECONDARY Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ |
58.9; 62.5; 25.8; 20.8 | — |
| SECONDARY Change From Baseline in the Emotional Function (EF) Domain of the MSQ |
53.3; 58.7; 26.2; 18.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01833130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.