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Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
Plain-language guide to NCT03791515: not phased non-randomized trial of CGRP (Calcitonin Gene-Related Peptide), concussion, traumatic brain injury & stroke recovery, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03791515
- Phase
- not phased
- Status
- completed
- Start
- 2018-07-26
- Completion (planned or actual)
- 2019-12-01
- Participants
- 200 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), other
- Conditions studied
- Post-Traumatic Headache; Concussion, Mild
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test CGRP (Calcitonin Gene-Related Peptide) for concussion, traumatic brain injury & stroke recovery.
It had two arms (groups): Calcitonin Gene-Related Peptide (CGRP) (active comparator) and Placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
The present project will embark upon identifying novel PTH-specific biomarkers by incorporating a plethora of scientific approaches.
First, clinical biomarkers will be assessed by deep phenotyping of clinical characteristics and associated comorbidities using a semi-structured interview and multiple validated questionnaires.
Third, imaging biomarkers will be established by magnetic resonance imaging (MRI) to assess structural and functional changes in the brain.
Who Took Part
200 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 18-65 years of age.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: \> 1 episode with a sustained concussion; pregnant or lactating women; cardiovascular disease of any kind.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The CGRP (Calcitonin Gene-Related Peptide) group and the comparison group ran side by side rather than switching.
Being open-label, the CGRP (Calcitonin Gene-Related Peptide) study did not mask who received what.
It started in 2018-07-26 with completion listed for 2019-12-01.
It ran at 1 site in Denmark.
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Cognitive Function (time frame: 10 minutes). Depression (time frame: 10 minutes). Anxiety (time frame: 10 minutes).
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of CGRP (Calcitonin Gene-Related Peptide) in 200 people with concussion, traumatic brain injury & stroke recovery.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Concussion, traumatic brain injury & stroke recovery research.
Our Notes on the Compound
CGRP (Calcitonin Gene-Related Peptide): A 37-amino-acid neuropeptide that widens blood vessels and is involved in migraine; given in research provocation studies.
Related Pages
- Concussion, traumatic brain injury & stroke recovery research
- CGRP (Calcitonin Gene-Related Peptide) in the library
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.