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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833130

Enrollment

Registered

2013-04-16

Start date

2013-04-30

Completion date

2014-09-30

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine

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.

Interventions

BIOLOGICALOnabotulinumtoxinA

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.

DRUGNormal saline (placebo)

Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.
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.

Countries

United States

Participant flow

Recruitment details

The Safety Population includes all 52 patients who received at least one injection with the study treatment. The Intent-to-Treat (ITT) population consists of all 45 randomized patients. Seven (7) patients were excluded from the ITT population as they were withdrawn from the study due to a randomization error.

Participants by arm

Arm	Count
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.	19
Placebo (Normal Saline) Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.	26
Total	45

Baseline characteristics

Characteristic	Placebo (Normal Saline)	OnabotulinumtoxinA	Total
Age, Continuous	42.2 Years STANDARD_DEVIATION 11.8	43.7 Years STANDARD_DEVIATION 13.1	42.8 Years STANDARD_DEVIATION 12.2
Sex: Female, Male Female	23 Participants	16 Participants	39 Participants
Sex: Female, Male Male	3 Participants	3 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	9 / 25	2 / 27
serious Total, serious adverse events	0 / 25	1 / 27

Outcome results

Primary

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.

Time frame: Baseline, Week 24