Trials / Not Yet Recruiting
Not Yet RecruitingNCT07340775
Hypersensitivity to Amylin in Post-Traumatic Headache
Hypersensitivity to Amylin in Post-Traumatic Headache: A Randomized Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Danish Headache Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
Amylin is a vasodilator released from nerve fibers within the trigeminovascular system, which is considered a key anatomical and physiological substrate in the pathogenesis of migraine and persistent post-traumatic headache (PTH). Persistent PTH attributed to mild traumatic brain injury frequently presents with migraine attacks, suggesting shared underlying mechanisms with migraine. This study aims to determine whether intravenous infusion of pramlintide, an analogue of amylin, can induce migraine-like headache in individuals with persistent post-traumatic headache. To test this hypothesis, we will conduct a randomized, double-blind, placebo-controlled, two-way crossover study.
Conditions
- Headache 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amylin | The participants will receive continuous intravenous infusion of 6 μg/min of pramlintide (amylin) over 20 minutes. |
| DRUG | Placebo | The participants will receive continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes. |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2026-01-14
- Last updated
- 2026-01-14
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT07340775. Inclusion in this directory is not an endorsement.