Hypersensitivity to Adrenomedullin in Post-Traumatic Headache

ConditionPosttraumatic Headache

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorDanish Headache Center

About this trial

Adrenomedullin is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether adrenomedullin induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

> 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

Trial design

Design model

Crossover

Treatments tested in this trial

Adrenomedullin
Drug
The participants will receive continuous intravenous infusion of 20 mL of 19.9 pmol/kg/min adrenomedullin over 20 minutes.
Placebo
Drug
The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Treatment groups

21 Participants

are divided into 2 treatment groups

Group A: AdrenomedullinExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of headache with migraine-like features

The difference in incidence of headache with migraine-like features between adrenomedullin and placebo during the 12-hour observational period after infusion start.

Time frame

12 hours

Secondary outcomes

Headache Intensity Scores

The secondary outcome is the difference in the area under the curve (AUC) for headache intensity scores between adrenomedullin and placebo during the 12-hour observational period after infusion start.

Time frame

12 hours

Sponsors and contacts

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Danish Headache Center

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov

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