Trial Outcomes & Findings for Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®) (NCT NCT01833130)

NCT ID: NCT01833130

Last Updated: 2015-10-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2015-10-21

Participant Flow

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 Seven (7) patients were excluded from the ITT population as they were withdrawn from the study due to a randomization error.

Participant milestones

Measure	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) Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Overall Study STARTED	25	27
Overall Study COMPLETED	15	8
Overall Study NOT COMPLETED	10	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.	Total n=45 Participants Total of all reporting groups
Age, Continuous	43.7 Years STANDARD_DEVIATION 13.1 • n=93 Participants	42.2 Years STANDARD_DEVIATION 11.8 • n=4 Participants	42.8 Years STANDARD_DEVIATION 12.2 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	23 Participants n=4 Participants	39 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score Baseline	50.5 Scores on a Scale Standard Deviation 17.6	47.2 Scores on a Scale Standard Deviation 22
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score Change from Baseline at Week 24 (N=15, 18)	-25.2 Scores on a Scale Standard Deviation 23.5	-20.5 Scores on a Scale Standard Deviation 24.6

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire Baseline	54.3 Scores on a Scale Standard Deviation 22.1	45.9 Scores on a Scale Standard Deviation 25.9
Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire Change from Baseline at Week 24 (N=14, 18)	-18.5 Scores on a Scale Standard Deviation 39.2	-17.5 Scores on a Scale Standard Deviation 30.1

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire Baseline	8.4 Scores on a Scale Standard Deviation 2.6	8.2 Scores on a Scale Standard Deviation 3.3
Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire Change from Baseline at Week 24 (N=14, 18)	-1.6 Scores on a Scale Standard Deviation 5.4	-1.9 Scores on a Scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire Baseline	45 Scores on a Scale Standard Deviation 16.6	43.3 Scores on a Scale Standard Deviation 21.1
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-15.7 Scores on a Scale Standard Deviation 24.7	-15.3 Scores on a Scale Standard Deviation 21.4
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-30.4 Scores on a Scale Standard Deviation 19.1	-18.7 Scores on a Scale Standard Deviation 24.4
Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-24 Scores on a Scale Standard Deviation 24.8	-21.9 Scores on a Scale Standard Deviation 24.8

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire Baseline	51.9 Scores on a Scale Standard Deviation 23.1	42.3 Scores on a Scale Standard Deviation 25.4
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-20 Scores on a Scale Standard Deviation 32	-13.9 Scores on a Scale Standard Deviation 20.8
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-26.7 Scores on a Scale Standard Deviation 33.3	-14.9 Scores on a Scale Standard Deviation 26.6
Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-26.2 Scores on a Scale Standard Deviation 28.4	-16.3 Scores on a Scale Standard Deviation 21

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire Baseline	47.9 Scores on a Scale Standard Deviation 23.2	43.1 Scores on a Scale Standard Deviation 26.9
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-16.7 Scores on a Scale Standard Deviation 36.4	-20.5 Scores on a Scale Standard Deviation 29.1
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-32.3 Scores on a Scale Standard Deviation 28.0	-16 Scores on a Scale Standard Deviation 40.7
Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-30 Scores on a Scale Standard Deviation 28.0	-18.9 Scores on a Scale Standard Deviation 33.1

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire Baseline	39.6 Scores on a Scale Standard Deviation 22.8	43.1 Scores on a Scale Standard Deviation 26.3
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-9.8 Scores on a Scale Standard Deviation 25.7	-21.8 Scores on a Scale Standard Deviation 24.8
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-19 Scores on a Scale Standard Deviation 26.5	-20 Scores on a Scale Standard Deviation 28.4
Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-18.7 Scores on a Scale Standard Deviation 25.5	-19.6 Scores on a Scale Standard Deviation 29.3

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire Baseline	51.6 Scores on a Scale Standard Deviation 21.4	55.4 Scores on a Scale Standard Deviation 31.1
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-16 Scores on a Scale Standard Deviation 33.1	-25.3 Scores on a Scale Standard Deviation 27.4
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-29.2 Scores on a Scale Standard Deviation 24	-22.7 Scores on a Scale Standard Deviation 38.4
Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-26.7 Scores on a Scale Standard Deviation 24.7	-30.0 Scores on a Scale Standard Deviation 37.7

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire Baseline	45.3 Scores on a Scale Standard Deviation 19.8	48.5 Scores on a Scale Standard Deviation 23.4
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-17.3 Scores on a Scale Standard Deviation 30.1	-18.9 Scores on a Scale Standard Deviation 26.2
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-27.7 Scores on a Scale Standard Deviation 25.2	-24 Scores on a Scale Standard Deviation 34
Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-24 Scores on a Scale Standard Deviation 28.5	-24.4 Scores on a Scale Standard Deviation 29.6

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire Baseline	58.2 Scores on a Scale Standard Deviation 22.2	60.2 Scores on a Scale Standard Deviation 19.9
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-19.7 Scores on a Scale Standard Deviation 34.2	-22.4 Scores on a Scale Standard Deviation 24.1
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-33.1 Scores on a Scale Standard Deviation 30.3	-20 Scores on a Scale Standard Deviation 31.8
Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=15, 18)	-26.3 Scores on a Scale Standard Deviation 27.3	-23.3 Scores on a Scale Standard Deviation 27.8

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=18 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=13, 15)	-31.1 Scores on a Scale Standard Deviation 30.3	-20.9 Scores on a Scale Standard Deviation 32.8
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=14, 18)	-31.8 Scores on a Scale Standard Deviation 29.3	-26.3 Scores on a Scale Standard Deviation 27.3
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire Baseline	60.0 Scores on a Scale Standard Deviation 19.9	52.6 Scores on a Scale Standard Deviation 27.0
Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-25.2 Scores on a Scale Standard Deviation 29.8	-20.7 Scores on a Scale Standard Deviation 25.5

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 22, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire Baseline	57.9 Scores on a Scale Standard Deviation 23	53.1 Scores on a Scale Standard Deviation 29.9
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 12 (N=15, 19)	-22.7 Scores on a Scale Standard Deviation 36.1	-18.9 Scores on a Scale Standard Deviation 25.4
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 22 (N=12, 15)	-38.3 Scores on a Scale Standard Deviation 31.3	-10.7 Scores on a Scale Standard Deviation 39.2
Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire Change from Baseline at Week 24 (N=14, 18)	-28.6 Scores on a Scale Standard Deviation 31.1	-15.6 Scores on a Scale Standard Deviation 45.3

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score Baseline	64.7 Scores on a Scale Standard Deviation 4.2	65.3 Scores on a Scale Standard Deviation 5.5
Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score Change from Baseline at Week 24 (N=15, 18)	-5.1 Scores on a Scale Standard Deviation 4.7	-6.7 Scores on a Scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) Baseline	39.8 Scores on a Scale Standard Deviation 16.6	40.9 Scores on a Scale Standard Deviation 21.7
Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ) Change from Baseline at Week 24 (N=13, 18)	32.1 Scores on a Scale Standard Deviation 15.4	26.5 Scores on a Scale Standard Deviation 28.9

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ Baseline	58.9 Scores on a Scale Standard Deviation 18.8	62.5 Scores on a Scale Standard Deviation 23.0
Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ Change from Baseline at Week 24 (N=13, 18)	25.8 Scores on a Scale Standard Deviation 18	20.8 Scores on a Scale Standard Deviation 28.9

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Intent-to-Treat: all randomized patients

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.

Outcome measures

Measure	OnabotulinumtoxinA n=19 Participants 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) n=26 Participants Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Change From Baseline in the Emotional Function (EF) Domain of the MSQ Baseline	53.3 Scores on a Scale Standard Deviation 27.6	58.7 Scores on a Scale Standard Deviation 23.9
Change From Baseline in the Emotional Function (EF) Domain of the MSQ Change from Baseline at Week 24 (N=14, 18)	26.2 Scores on a Scale Standard Deviation 26.3	18.5 Scores on a Scale Standard Deviation 34.2

Adverse Events

OnabotulinumtoxinA

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	OnabotulinumtoxinA n=25 participants at risk 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) n=27 participants at risk Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Nervous system disorders Cerebrovascular Accident	0.00% 0/25 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.	3.7% 1/27 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.

Other adverse events

Measure	OnabotulinumtoxinA n=25 participants at risk 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) n=27 participants at risk Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
General disorders Injection Site Pain	8.0% 2/25 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.	3.7% 1/27 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.
Musculoskeletal and connective tissue disorders Neck Pain	16.0% 4/25 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.	3.7% 1/27 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.
Musculoskeletal and connective tissue disorders Shoulder Pain	12.0% 3/25 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.	0.00% 0/27 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.
Nervous system disorders Facial Paresis	8.0% 2/25 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.	0.00% 0/27 The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all subjects who received at least one study treatment injection.

Additional Information

Medical Director,

Allergan, Inc

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER