Clinical Characteristics and Pathophysiology of Post-Traumatic Headache

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin gene-related peptide (CGRP) hypersensitivity in PPTH patients.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin; Salmon calcitonin

Criteria

Inclusion Criteria for PPTH patients:

• 18-65 years of age

• Subject has PPTH in accordance with the diagnostic criteria of the International Headache Society (IHS)

• Concussion (mild traumatic brain injury) occured > 12 months ago

• Subject, who are fertile women, must be on safe contraceptives

Exclusion Criteria for PPTH patients:

• Pre-trauma existing primary headache disorder (maximum 1 day/per month with tension-type headache) and medication-overuse headache

• > 1 episode with a sustained concussion

• Whiplash

• Pregnant or lactating women

• Cardiovascular disease of any kind

• Hypertension on the experimental day

• Hypotension on the experimental day

• Pre-trauma existing psychiatric disorder of any kind - unless well-regulated

• Any anamnestic or clinical signs of any kind deemed relevant for the study by the physician examining the subject

• Any MRI contraindication and a wish of not being informed about unexpected MRI changes