Post-Traumatic HeadachePhase 4NCT03928496
Abobotulinumtoxina Efficacy in Post-Traumatic Headache
A Phase 4 study testing AbobotulinumtoxinA and Normal saline in people with Post-Traumatic Headache, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- AbobotulinumtoxinA and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 2 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- age 18-65
- meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
- average pain score of greater than 4/10 in severity on the numerical rating system
- Rancho Los Amigos cognitive scale score greater than seven.
Who cannot join
- Uncontrolled medical condition other than PTH
- Severe additional chronic pain complaint which could not be distinguished from headache pain
- pregnancy, breast feeding,
- prior treatment with botulinum toxin within one year of enrollment
- current substance abuse/dependence
- medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
Show all 9Show fewer
- poorly controlled psychiatric
- initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
- ongoing disability or litigation claim.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache
Read the detailed description
A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.
Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.
- Conditions
- Post-Traumatic Headache
- Being tested
- AbobotulinumtoxinA, Normal saline
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinADrug
Also called Dysport
Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck
Normal salineDrug
Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
| Study group | Role | What they receive |
|---|---|---|
| Abobotulinumtoxina | Experimental | 300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck Receives: Drug: AbobotulinumtoxinA |
| Placebo | Placebo comparator | 0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of headaches from baseline
Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up
Measured: evaluation from time of injection until completion of 12 week follow-up
Secondary outcomes (2)
Intensity of headache pain
Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.
Measured: evaluation from time of injection until completion of 12 week follow-up
Number of headache days per week
Evaluation of the number of days a headache was present over each week
Measured: evaluation from time of injection until completion of 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Aug 2013
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Milena Zirovich, MD, Principal investigator, VA Greater Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928496
- Sponsor's protocol ID
- Zirovich0002
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset may be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abobotulinumtoxina Efficacy in Post-Traumatic Headache
- ClinicalTrials.gov ID
- NCT03928496
- Acronym / sponsor ID
- Zirovich0002
- Conditions
- Post-Traumatic Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- Ipsen
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
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 evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache
Detailed description
A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.
Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abobotulinumtoxina | Experimental | Drug: AbobotulinumtoxinA300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck |
| Placebo | Placebo comparator | Drug: Normal saline0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female
- age 18-65
- meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
- average pain score of greater than 4/10 in severity on the numerical rating system
- Rancho Los Amigos cognitive scale score greater than seven.
Key exclusion criteria (9 listed)
- Uncontrolled medical condition other than PTH
- Severe additional chronic pain complaint which could not be distinguished from headache pain
- pregnancy, breast feeding,
- prior treatment with botulinum toxin within one year of enrollment
- current substance abuse/dependence
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 |
|---|---|---|
| AbobotulinumtoxinAAlso: DysportSubjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck | Drug | Abobotulinumtoxina |
| Normal salineSubjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck | Drug | Placebo |
Primary outcome
Incidence of headaches from baseline
Time frame: evaluation from time of injection until completion of 12 week follow-up
Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up
2 secondary outcomes
Intensity of headache pain
Time frame: evaluation from time of injection until completion of 12 week follow-up
Number of headache days per week
Time frame: evaluation from time of injection until completion of 12 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: Yes. A de-identified dataset may be provided upon request
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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.
Milena Zirovich, MD principal investigator
VA Greater Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AbobotulinumtoxinA and Normal saline in people with Post-Traumatic Headache, run by VA Greater Los Angeles Healthcare System 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 26 Apr 2019. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of headaches from baseline (time frame: evaluation from time of injection until completion of 12 week follow-up). 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 26 Apr 2019.