Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
NCT ID: NCT03791515
Last Updated: 2020-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2018-07-26
2019-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Lastly, the 30 patients with PPTH will participate in a randomized, double-blind, placebo-controlled, 2-way crossover study. These patients will be allocated to receive intravenous infusion of CGRP or placebo (isotonic saline) over 20 minutes on 2 study days.
OTHER
NONE
Study Groups
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Calcitonin Gene-Related Peptide (CGRP)
30 patients with PPTH will be allocated to receive intravenous infusion of 1.5 µg/min calcitonin-gene related peptide over 20 minutes
Other Name: CGRP
Calcitonin Gene-Related Peptide
A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 1.5 µg/min CGRP over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
Placebo
30 patients with PPTH wil be allocated to receive 40 mL Placebo (isotonic saline) over 20 minutes.
Other Name: Isotonic Saline
Placebo
A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 40 mL placebo (isotonic saline) over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
Interventions
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Calcitonin Gene-Related Peptide
A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 1.5 µg/min CGRP over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
Placebo
A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 40 mL placebo (isotonic saline) over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* \> 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
18 Years
65 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Henrik Schytz
Associate Professor of Neurology
Principal Investigators
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Henrik Schytz, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
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Danish Headache Center
Glostrup Municipality, , Denmark
Countries
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References
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Schytz HW, Smilkov E, Carroll I, Dobrocky T, Al-Khazali HM, Tolnai D, Jensen RH, Amin FM. No evidence of intracranial hypotension in persistent post-traumatic headache: A magnetic resonance imaging study. Cephalalgia. 2025 Apr;45(4):3331024251325556. doi: 10.1177/03331024251325556. Epub 2025 Apr 21.
Other Identifiers
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H-18011477
Identifier Type: -
Identifier Source: org_study_id
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