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
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
Treatments tested in this trial
- Adrenomedullin
- Placebo
Treatment groups
21 Participants
are divided into 2 treatment groupsSponsors and collaborators
Danish Headache Center
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov