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Hypersensitivity to Opening of BKCa Channels in Post-Traumatic Headache

D

Danish Headache Center

Status

Enrolling

Conditions

Post-Traumatic Headache

Treatments

Drug: Maxipost
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05378074
H-21048424

Details and patient eligibility

About

The aim is to investigate whether opening of large conductance calcium-activated potassium (BKCa) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Enrollment

21 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

21 participants in 2 patient groups, including a placebo group

MaxiPost
Experimental group
Description:
A time- and volume-controlled infusion pump is used to administer MaxiPost by intravenous infusion over 20 minutes.
Treatment:
Drug: Maxipost
Placebo (isotonic saline)
Placebo Comparator group
Description:
A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Hakan Ashina, MD

Data sourced from clinicaltrials.gov

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