Trial Outcomes & Findings for Sumatriptan as Treatment for Post-traumatic Headache (NCT NCT01854385)

Last Updated: 2022-01-11

Results Overview

percent of headaches that had complete resolution (pain free at 2 hours) for each person, during the initial (pre-intervention) month when they used their regular treatment and during the second of the two months (intervention) when they treated headaches with sumatriptan compared using a mixed-effects regression model. Reported number is the difference in headache resolution from the pre-intervention headaches to the intervention headaches.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

1 month

Results posted on

2022-01-11

Participant Flow

Recruitment occurred between August 2013 and January 2018.

Participant milestones

Participant milestones
Measure	Sumatriptan Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Pre-Treatment STARTED	40
Pre-Treatment COMPLETED	17
Pre-Treatment NOT COMPLETED	23
Treatment STARTED	17
Treatment COMPLETED	16
Treatment NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sumatriptan Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Pre-Treatment Withdrawal by Subject	4
Pre-Treatment Did not meet criteria based on headache number	15
Pre-Treatment Disqualified based on blood pressure requirement	3
Pre-Treatment Unable to come for study visits	1
Treatment Lost to Follow-up	1

Baseline Characteristics

Exact injury date unknown for two participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sumatriptan n=40 Participants Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants
Age, Continuous	41.9 years STANDARD_DEVIATION 14.2 • n=40 Participants
Sex: Female, Male Female	19 Participants n=40 Participants
Sex: Female, Male Male	21 Participants n=40 Participants
Race/Ethnicity, Customized Race · White	27 Participants n=40 Participants
Race/Ethnicity, Customized Race · Black	3 Participants n=40 Participants
Race/Ethnicity, Customized Race · Asian/Pacific Islander	3 Participants n=40 Participants
Race/Ethnicity, Customized Race · Hispanic	5 Participants n=40 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants
Post-Injury Months	13.4 months STANDARD_DEVIATION 11.5 • n=38 Participants • Exact injury date unknown for two participants.

PRIMARY outcome

Timeframe: 1 month

Population: Subjects with complete pre-intervention and intervention data

Outcome measures

Outcome measures
Measure	Sumatriptan n=11 Participants Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Change in Headache Relief	23 percentage of headaches resolved Interval -3.0 to 50.0

SECONDARY outcome

Timeframe: 2 months

Population: participants that completed the intervention

The investigators will calculate the percent who stopped taking sumatriptan because of side effects, percent who experienced each adverse event.

Outcome measures

Outcome measures
Measure	Sumatriptan n=15 Participants Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Adverse Events Stopped taking sumatriptan due to side effects	0 participants
Adverse Events Rebound headaches	1 participants
Adverse Events Fatigue/drowsiness	2 participants
Adverse Events Dizziness	2 participants
Adverse Events Gastrointestinal symptoms	4 participants
Adverse Events Numbness/Tingling	2 participants
Adverse Events Itch/rash	1 participants
Adverse Events Joint pain	1 participants
Adverse Events Restlessness	1 participants
Adverse Events Sweating/flushing	2 participants
Adverse Events Elevated blood pressure	1 participants
Adverse Events Anxiety	1 participants
Adverse Events Sore Throat	1 participants

SECONDARY outcome

Timeframe: 1 month

Population: participants that completed the intervention with valid diary entries

The investigators will calculate the mean percentage of headache diary completion of intervention subjects in the final month of participation.

Outcome measures

Outcome measures
Measure	Sumatriptan n=15 Participants Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Headache Diary Compliance	80 percentage of diary days completed Standard Deviation 22

SECONDARY outcome

Timeframe: 1 month

Population: participants that completed the intervention with valid diary entries

Mean rate of headaches treated with sumatriptan in final month of intervention.

Outcome measures

Outcome measures
Measure	Sumatriptan n=15 Participants Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Sumatriptan Compliance	25 percentage of headaches Standard Deviation 22

Adverse Events

Sumatriptan

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sumatriptan n=17 participants at risk Open label study of sumatriptan to treat post-traumatic headache. Subjects will use sumatriptan 100 mg at the onset of headache pain and may repeat the dose if not pain-free in 2 hours. Subjects will receive a maximum of 18 pills for use over two months. Subjects will maintain a daily headache diary. Sumatriptan 100 mg: This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
Nervous system disorders Rebound headaches	5.9% 1/17 • Number of events 1 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Nervous system disorders Fatigue/Drowsiness	11.8% 2/17 • Number of events 5 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Gastrointestinal disorders Gastrointestinal Issues	23.5% 4/17 • Number of events 6 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
General disorders Numbness/Tingling	11.8% 2/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
General disorders Itch/Rash	5.9% 1/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Musculoskeletal and connective tissue disorders Joint pain	5.9% 1/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Nervous system disorders Restlessness	5.9% 1/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Vascular disorders Sweating/Flushing	11.8% 2/17 • Number of events 5 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Vascular disorders Elevated blood pressure	5.9% 1/17 • Number of events 1 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 2 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.
Respiratory, thoracic and mediastinal disorders Sore Throat	5.9% 1/17 • Number of events 1 • Adverse event data was collected from participants who enrolled in the intervention portion of the study, from the time of consent and dispensation of study drug until the end of their study treatment follow-up - approximately three months. For this study, the end of the study treatment follow-up is defined as 30 days following the last study clinic visit.

Additional Information

Dr. Jeanne Hoffman

University of Washington

Phone: (206) 221-6511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place