Hypersensitivity to Amylin in Post-Traumatic Headache

ConditionsHeadache Disorders, Secondary Brain Diseases Headache Disorders Nervous System Diseases Central Nervous System Diseases Neurologic Manifestations Signs and Symptoms Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Pain Peptide Hormones Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Peptides Amino Acids, Peptides, and Proteins Amylin Pramlintide

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorDanish Headache Center

About this trial

Pramlintide is a peptide analogue of human amylin which is a vasoactive substance involved in the pathogenesis of headache. This study investigates whether pramlintide induces migraine-like headache 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

Amylin
Drug
The participants will receive continuous intravenous infusion of 6 μg/min of pramlintide (amylin) over 20 minutes.
Placebo
Drug
The participants will receive 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: AmylinExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of migraine-like headache

Difference in incidence of migraine-like headache (0 to 12 hours) between pramlintide and placebo.

Time frame

12 hours

Secondary outcomes

Headache Intensity Scores

Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between pramlintide and placebo.

Time frame

12 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: