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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05243953
Other study ID # H-21043704
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date July 7, 2022

Study information

Verified date July 2022
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date July 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - > 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levcromakalim
Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim.
Placebo
Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).

Locations

Country Name City State
Denmark Danish Headache Center Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Migraine-Like Headache Difference in incidence of headache with migraine-like features (0 to 12 hours) between levcromakalim and placebo. 12 Hours
Secondary Headache Intensity Scores Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between levcromakalim and placebo. 12 Hours
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