Trial Outcomes & Findings for Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA (NCT NCT02160535)

Results Overview

To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

Baseline, 9 months

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment With OnabotulinumtoxinA OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With OnabotulinumtoxinA n=13 Participants OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Age, Categorical <=18 years	1 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Sex: Female, Male Female	12 Participants n=13 Participants
Sex: Female, Male Male	1 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants

PRIMARY outcome

Timeframe: Baseline, 9 months

To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).

Outcome measures

Outcome measures
Measure	Treatment With OnabotulinumtoxinA n=13 Participants OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Change in Mean Percentage of Headache Days Baseline	83 percentage of headache days Standard Deviation 21
Change in Mean Percentage of Headache Days 9 month	49 percentage of headache days Standard Deviation 34

SECONDARY outcome

Timeframe: Baseline and 9 month.

Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.

Outcome measures

Outcome measures
Measure	Treatment With OnabotulinumtoxinA n=13 Participants OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Change in SF-36 Assessment Scores Baseline	47 score on a scale Standard Deviation 30
Change in SF-36 Assessment Scores 9 months	66 score on a scale Standard Deviation 29

SECONDARY outcome

Timeframe: Baseline and 9 month.

Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.

Outcome measures

Outcome measures
Measure	Treatment With OnabotulinumtoxinA n=13 Participants OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Change in MIDAS Score 9 months	21 score on a scale Standard Deviation 18
Change in MIDAS Score Baseline	89 score on a scale Standard Deviation 51

SECONDARY outcome

Timeframe: Baseline and 9 month.

Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.

Outcome measures

Outcome measures
Measure	Treatment With OnabotulinumtoxinA n=13 Participants OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
Change in HIT-6 Score. Baseline	65 score on a scale Standard Deviation 4
Change in HIT-6 Score. 9 months	59 score on a scale Standard Deviation 7

Adverse Events

Treatment With OnabotulinumtoxinA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment With OnabotulinumtoxinA n=13 participants at risk OnabotulinumtoxinA OnabotulinumtoxinA: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
General disorders Increased Headache	7.7% 1/13 • Number of events 1

Additional Information

Dr. Sylvia Lucas, MD, PhD

University of Washington

Phone: 206-598-9260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place