Chronic Post Traumatic HeadachePhase 3NCT02160535
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
A Phase 3 study testing OnabotulinumtoxinA in people with Chronic Post Traumatic Headache, run by University of Washington at 1 site in United States.
Trial summary
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Post Traumatic Headache
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
- Suffer at least fifteen total headache days per month
- Ability to speak and read English
Who cannot join
- Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
- Previous use of OnabotulinumtoxinA for treatment of headache
- Any medications commonly used as headache preventives started less than 3 months prior to enrollment
- Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
- Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
- Subjects who are pregnant or trying to become pregnant within the timeframe of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Headache Clinic
Seattle, Washington, 98195
About this study
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.
Read the detailed description
Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.
- Conditions
- Chronic Post Traumatic Headache
- Being tested
- OnabotulinumtoxinA
- Keywords
- Mild Traumatic Brain Injury, Concussion, Post Concussive Headache
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called BOTOX
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment with OnabotulinumtoxinA | Experimental | OnabotulinumtoxinA Receives: Drug: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Percentage of Headache Days
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).
Measured: Baseline, 9 months
Secondary outcomes (3)
Change in SF-36 Assessment Scores
Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.
Measured: Baseline and 9 month.
Change in MIDAS Score
Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.
Measured: Baseline and 9 month.
Change in HIT-6 Score.
Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.
Measured: Baseline and 9 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Study discontinued due to difficulty in enrolling eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Post Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Lucas, University of Washington
- Investigators
- Sylvia Lucas, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160535
- Sponsor's protocol ID
- 46614
- Status last verified
- Oct 2018
- First submitted
- 15 May 2014
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA
- ClinicalTrials.gov ID
- NCT02160535
- Acronym / sponsor ID
- 46614
- Conditions
- Chronic Post Traumatic Headache
- Keywords
- Mild Traumatic Brain Injury, Concussion, Post Concussive Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to difficulty in enrolling eligible subjects
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.
Detailed description
Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with OnabotulinumtoxinA | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
- Suffer at least fifteen total headache days per month
- Ability to speak and read English
Key exclusion criteria (6 listed)
- Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
- Previous use of OnabotulinumtoxinA for treatment of headache
- Any medications commonly used as headache preventives started less than 3 months prior to enrollment
- Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
- Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: BOTOX155 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 | Drug | Treatment with OnabotulinumtoxinA |
Primary outcome
Change in Mean Percentage of Headache Days
Time frame: 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).
3 secondary outcomes
Change in SF-36 Assessment Scores
Time frame: Baseline and 9 month.
Change in MIDAS Score
Time frame: Baseline and 9 month.
Change in HIT-6 Score.
Time frame: Baseline and 9 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Lucas, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OnabotulinumtoxinA in people with Chronic Post Traumatic Headache, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Percentage of Headache Days (time frame: Baseline, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.