Trial Outcomes & Findings for A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine (NCT NCT02147561)

NCT ID: NCT02147561

Last Updated: 2016-05-27

Results Overview

An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 280 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2016-05-27

Participant Flow

Participant milestones

Measure	Botulinum Toxin Type A Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Study STARTED	280
Overall Study COMPLETED	276
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Botulinum Toxin Type A Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Overall Study Lost to Follow-up	3
Overall Study Subjects who didn't receive BOTOX	1

Baseline Characteristics

A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine

Baseline characteristics by cohort

Measure	Botulinum Toxin Type A n=279 Participants Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Age, Continuous	49.81 Years STANDARD_DEVIATION 14.56 • n=5 Participants
Sex: Female, Male Female	229 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: Safety Population: patients enrolled in the study who received study drug

An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Outcome measures

Measure	Botulinum Toxin Type A n=279 Participants Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Percentage of Patients With Adverse Events	24.37 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment

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	Botulinum Toxin Type A n=276 Participants Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score Baseline	67.54 Scores on a Scale Standard Deviation 5.83
Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score Change from Baseline at Day 28	-7.32 Scores on a Scale Standard Deviation 7.98

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment

Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.

Outcome measures

Measure	Botulinum Toxin Type A n=276 Participants Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Physician Global Assessment of Outcome on a 3-Point Scale Improved	200 Patients
Physician Global Assessment of Outcome on a 3-Point Scale No Change	72 Patients
Physician Global Assessment of Outcome on a 3-Point Scale Worse	4 Patients

Adverse Events

Botulinum Toxin Type A

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Botulinum Toxin Type A n=279 participants at risk Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.36% 1/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
General disorders Fever	0.36% 1/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
Gastrointestinal disorders Diarrhoea	0.36% 1/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
Nervous system disorders Migraine	0.36% 1/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
Infections and infestations Common Cold	0.36% 1/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.

Other adverse events

Measure	Botulinum Toxin Type A n=279 participants at risk Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Musculoskeletal and connective tissue disorders Muscle Weakness	8.6% 24/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
Nervous system disorders Ptosis	5.0% 14/279 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

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