Post-Traumatic HeadacheNCT05243953
Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache
A study testing Levcromakalim in people with Post-Traumatic Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Levcromakalim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Mar 2022to 7 Jul 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years of age upon entry into screening
- History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- ≥ 4 monthly headache days on average across the 3 months prior to screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures.
Who cannot join
- > 1 mild traumatic injury to the head
- History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
- History of moderate or severe injury to the head
- History of whiplash injury
- History of craniotomy
- History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
Show all 15Show fewer
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- Female subjects of childbearing potential with a positive pregnancy test during any study visit
- Cardiovascular disease of any kind, including cerebrovascular diseases
- Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
- Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
- Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
- Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
- Baseline headache intensity of >3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
- Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache: A Randomized Clinical Trial
The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
- Conditions
- Post-Traumatic Headache
- Being tested
- Levcromakalim, Placebo
- Keywords
- Headache, Pain
- Medical subject headings
- Post-Traumatic Headache, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim.
PlaceboDrug
Also called Isotonic Saline
Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).
| Study group | Role | What they receive |
|---|---|---|
| Levcromakalim | Experimental | A time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes. Receives: Drug: Levcromakalim |
| Placebo (isotonic saline) | Placebo comparator | A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Migraine-Like Headache
Difference in incidence of headache with migraine-like features (0 to 12 hours) between levcromakalim and placebo.
Measured: 12 Hours
Secondary outcomes (1)
Headache Intensity Scores
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between levcromakalim and placebo.
Measured: 12 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start21 Mar 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Håkan Ashina, Danish Headache Center
- Investigators
- Hakan Ashina, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243953
- Sponsor's protocol ID
- H-21043704
- Status last verified
- Jul 2022
- First submitted
- 8 Feb 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Khazali HM, Christensen RH, Dodick DW, Chaudhry BA, Burstein R, Ashina H. Hypersensitivity to opening of ATP-sensitive potassium channels in post-traumatic headache. Cephalalgia. 2023 Nov;43(11):3331024231210930. doi: 10.1177/03331024231210930.
PubMed 37917826
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05243953
- Acronym / sponsor ID
- H-21043704
- Conditions
- Post-Traumatic Headache
- Keywords
- Headache, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 17 Feb 2022 (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.
The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levcromakalim | Experimental | Drug: LevcromakalimA time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes. |
| Placebo (isotonic saline) | Placebo comparator | Drug: PlaceboA time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years of age upon entry into screening
- History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- ≥ 4 monthly headache days on average across the 3 months prior to screening
- Provision of informed consent prior to initiation of any study-specific activities/procedures.
Key exclusion criteria (15 listed)
- > 1 mild traumatic injury to the head
- History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
- History of moderate or severe injury to the head
- History of whiplash injury
- History of craniotomy
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 |
|---|---|---|
| LevcromakalimStudy participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim. | Drug | Levcromakalim |
| PlaceboAlso: Isotonic SalineStudy participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline). | Drug | Placebo (isotonic saline) |
Primary outcome
Incidence of Migraine-Like Headache
Time frame: 12 Hours
Difference in incidence of headache with migraine-like features (0 to 12 hours) between levcromakalim and placebo.
1 secondary outcome
Headache Intensity Scores
Time frame: 12 Hours
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 8 Jul 2022.
- Derived from this study: PubMed 37917826Al-Khazali HM, Christensen RH, Dodick DW, Chaudhry BA, Burstein R, Ashina H. Hypersensitivity to opening of ATP-sensitive potassium channels in post-traumatic headache. Cephalalgia. 2023 Nov;43(11):3331024231210930. doi: 10.1177/03331024231210930.
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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.
Hakan Ashina, MD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levcromakalim in people with Post-Traumatic Headache, run by Danish Headache Center at 1 site in Denmark.
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 4 inclusion and 15 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 8 Jul 2022. 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 Denmark. 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.
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 Migraine-Like Headache (time frame: 12 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243953, which also lists 1 linked publication.
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 8 Jul 2022.