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Hypersensitivity to PACAP-38 in Post-Traumatic Headache

NCT05378061 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-06-22

No results posted yet for this study

Summary

The aim is to investigate whether signaling molecule PACAP-38 induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).

Conditions

  • Post-Traumatic Headache

Interventions

DRUG

Pituitary adenylate cyclase activating polypeptide-38

Study participants will be allocated to receive continuous intravenous infusion of 10 pmol/kg/min PACAP-38.

DRUG

Placebo

Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).

Sponsors & Collaborators

  • Danish Headache Center

    lead OTHER

Principal Investigators

  • Hakan Ashina, MD · Danish Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378061 on ClinicalTrials.gov