Does adrenomedullin trigger migraine-like headaches in people with persistent post-traumatic headache?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses a randomized, double-blind, placebo-controlled, two-way crossover design in which participants receive an intravenous infusion of adrenomedullin on one visit and placebo on another. Adults aged 18–65 with persistent post-traumatic headache for at least 12 months and an average of ≥4 headache days per month are eligible, provided they had a single mild traumatic brain injury and no prior primary headache disorder. Investigators will record whether the infusion provokes headache with migraine-like features and monitor vital signs and adverse events throughout each visit. The crossover design allows each participant to serve as their own control, improving sensitivity to detect a provocation effect.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet-Glostrup
  Glostrup Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Haidar Al-Khazali, MD
• Email: haidardk@hotmail.com
• Phone: +4541598494

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Botox to treat posttraumatic headaches

  This study is testing if Botox can help people with posttraumatic headaches feel better by reducing how often and how badly they hurt.

  Recruiting Phase 3 Danish Headache Center · Glostrup Municipality · NCT06839118

• Ketamine, stellate ganglion block, or both for TBI-related headache and PTSD

  This trial will try ketamine infusions, a stellate ganglion block, or both to see if they reduce headaches and PTSD symptoms in adults with traumatic brain injury and/or PTSD.

  Recruiting at 2 sites Phase 2 Northwestern University · Chicago, Illinois and 2 other locations · NCT06608277

• Comparing telehealth and in-person therapy for chronic headaches in veterans

  This study is testing if therapy for chronic headaches delivered through telehealth is just as helpful as in-person therapy for veterans and active duty service members.

  Recruiting at 5 sites The University of Texas Health Science Center at San Antonio · Los Angeles, California and 7 other locations · NCT05620719

• Using a medication to treat headaches after mild brain injuries in military and civilian patients

  This study is testing if a new medication can help people with mild brain injuries and headaches feel better compared to a placebo.

  Recruiting at 2 sites Phase 2 Henry M. Jackson Foundation for the Advancement of Military Medicine · Fort Bragg, North Carolina and 3 other locations · NCT05049057

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.