Post-Traumatic HeadacheNCT03791515
Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
A study testing Calcitonin Gene-Related Peptide in people with Post-Traumatic Headache and Concussion, Mild, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache, Concussion, Mild
- What is being tested?
- Calcitonin Gene-Related Peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jul 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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. Second, biochemical biomarkers will be determined by plasma levels measurements of blood markers for headache hypersensitivity and neuronal/axonal damage. Third, imaging biomarkers will be established by magnetic resonance imaging (MRI) to assess structural and functional changes in the brain. Lastly, molecular biomarkers will be identified by examining whether intravenous infusion of calcitonin gene-related peptide (CGRP) provokes headache attacks mimicking the usual headache phenotype in subjects with PTH. This would determine whether PTH patients exhibit hypersensitivity to CGRP (molecular biomarker) and advance our understanding of the complex pathophysiological events that constitute the headache phenotypes in PTH sufferers.
- Conditions
- Post-Traumatic Headache, Concussion, Mild
- Being tested
- Calcitonin Gene-Related Peptide, Placebo
- Medical subject headings
- Post-Traumatic Headache, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin Gene-Related PeptideDrug
Also called CGRP
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.
PlaceboDrug
Also called Isotonic Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Calcitonin Gene-Related Peptide (CGRP) | Active comparator | 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 Receives: Drug: Calcitonin Gene-Related Peptide |
| Placebo | Placebo comparator | 30 patients with PPTH wil be allocated to receive 40 mL Placebo (isotonic saline) over 20 minutes.
Other Name: Isotonic Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Characteristics
Headache characteristics will be assessed using a semi-structured interview.
Measured: 50 minutes
Headache Characteristics
Headache characteristics will be assessed using Headache Under-Response to Treatment Index (HURT-Index) questionnaire. The total score ranges from 0 to 24 with a higher score indicating a lower effectiveness of intervention against headache.
Measured: 10 minutes
Cognitive Function
Cognitive function will be assessed using Montreal Cognitive Assessment (MoCA) questionnaire. The total score ranges from 0 to 30 points. The MoCA is divided into 7 subscores: visuospatial/executive (5 points); naming (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points). One point is added if the subject has ≤12 years of education. A total of 30 points may be given. A score ≤25 indicates some degree of cognitive impairment.
Measured: 10 minutes
Depression
Depression will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21.
A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a depressive state (borderline abnormal).
A score of 11-21 points indicates a probable presence of a depressive state (abnormal).
Measured: 10 minutes
Anxiety
Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire.
The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a state of anxiety (borderline abnormal).
A score of 11-21 points indicates a probable presence of an anxiety disorder (abnormal).
Measured: 10 minutes
Allodynia
Allodynia will be assessed using Allodynia Symptom Checklist (ASC-12) questionnaire. The total score ranges from 0-24 points.
A score of 0-2 suggests no allodynia. A score of 3-5 suggests mild allodynia. A score of 6-8 suggests moderate allodynia. A score of 9 or more suggests severe allodynia.
Measured: 10 minutes
Post-Traumatic Stress Disorder
Post-traumatic stress disorder will be assessed using Harvard Trauma Questionnaire (HTQ). The total score ranges from 16-64. The total score is divided with 16 and a clinical cut-off score of 2.5 is set to be indicative of PTSD.
Measured: 10 minutes
Quality of Sleep: Pittsburgh Sleep Quality Index (PSQ-I)
Quality of Sleep will be assessed using Pittsburgh Sleep Quality Index (PSQ-I). The measure consists of 19 individual items, creating 7 components that produce one global score. The total PSQ-I score ranges from 0 to 21 with lower scores indicating a healthier sleep quality.
Measured: 10 minutes
Muscle Tenderness
Muscle tenderness will be assessed using Total Tenderness Score (TTS). The total score ranges from 0-48 with higher scores indicating a higher degree of muscle tenderness.
Measured: 10 minutes
Pressure Pain Threshold
Pressure Pain Threshold will be assessed using an Algometer.
Measured: 10 minutes
Cortical Density
Cortical density will be assessed using Voxel-Based Morphometry.
Measured: 10 minutes
Cortical Thickness
Cortical thickness will be assessed using Surface-Based Morphometry
Measured: 10 minutes
Number and Location of Microhemorrhages
The number and location of microhemorrhages will be assessed using Susceptibility-Weighted Imaging.
Measured: 6 minutes
White Matter Structural Fiber Integrity
The white matter structural fiber integrity will be assessed using Diffusion Tensor Imaging
Measured: 10 minutes
Number and Location of White Matter Lesions
The number and location of white matter lesions will be assessed using T2-weighted Fluid-Attenuated Inversion Recovery.
Measured: 6 minutes
Cerebral Blood Flow
Cerebral blood flow will be assessed using arterial spin labelling (ASL).
Measured: 7 minutes
Brain Network Functional Connectivity
Brain network functional connectivity will be assessed using blood oxygen level-dependent functional magnetic resonance imaging.
Measured: 11 minutes
Incidence of Headache Exacerbation with Migraine-Like Features
Migraine-like features are defined as headache fulfilling at least two of the following four characteristics:
- Unilateral location
- Pulsating quality
- Moderate or severe pain intensity
- Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
And during headache at least one of the following must be fulfilled:
- Nausea and/or vomiting
- Photophobia and phonophobia
- Headache mimicking the usual exacerbated headache with migraine-like features
If the participant fulfills these criteria at baseline, then incidence of exacerbated headache with migraine-like features is defined as:
- An increase in headache intensity combined with an increase in the degree nausea and/or photophobia and phonophobia (based on a mild / moderate / severe scale)
Measured: 60 minutes
Headache Area under the Curve
Headache area under the curve is defined as headache intensity x duration up to 12 h after CGRP infusion
Measured: 12 hours
Time to Maximum Headache
Time to maximum headache score on CGRP day compared to placebo day will be assessed using a headache questionnaire
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start26 Jul 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 100 patients with PPTH and 100 healthy controls will undergo a deep phenotyping of clinical characteristics and associated comorbidities. This is followed by a single MRI-session for all subjects. 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Schytz, Danish Headache Center
- Investigators
- Henrik Schytz, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791515
- Sponsor's protocol ID
- H-18011477
- Status last verified
- Dec 2018
- First submitted
- 27 Jul 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40255022
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
- ClinicalTrials.gov ID
- NCT03791515
- Acronym / sponsor ID
- H-18011477
- Conditions
- Post-Traumatic Headache, Concussion, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Second, biochemical biomarkers will be determined by plasma levels measurements of blood markers for headache hypersensitivity and neuronal/axonal damage. Third, imaging biomarkers will be established by magnetic resonance imaging (MRI) to assess structural and functional changes in the brain. Lastly, molecular biomarkers will be identified by examining whether intravenous infusion of calcitonin gene-related peptide (CGRP) provokes headache attacks mimicking the usual headache phenotype in subjects with PTH. This would determine whether PTH patients exhibit hypersensitivity to CGRP (molecular biomarker) and advance our understanding of the complex pathophysiological events that constitute the headache phenotypes in PTH sufferers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 100 patients with PPTH and 100 healthy controls will undergo a deep phenotyping of clinical characteristics and associated comorbidities. This is followed by a single MRI-session for all subjects. 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.
| Arm | Type | Receives |
|---|---|---|
| Calcitonin Gene-Related Peptide (CGRP) | Active comparator | Drug: Calcitonin Gene-Related Peptide30 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 |
| Placebo | Placebo comparator | Drug: Placebo30 patients with PPTH wil be allocated to receive 40 mL Placebo (isotonic saline) over 20 minutes. Other Name: Isotonic Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitonin Gene-Related PeptideAlso: CGRPA 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. | Drug | Calcitonin Gene-Related Peptide (CGRP) |
| PlaceboAlso: Isotonic SalineA 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. | Drug | Placebo |
Primary outcome
Headache Characteristics
Time frame: 50 minutes
Headache characteristics will be assessed using a semi-structured interview.
Headache Characteristics
Time frame: 10 minutes
Headache characteristics will be assessed using Headache Under-Response to Treatment Index (HURT-Index) questionnaire. The total score ranges from 0 to 24 with a higher score indicating a lower effectiveness of intervention against headache.
Cognitive Function
Time frame: 10 minutes
Cognitive function will be assessed using Montreal Cognitive Assessment (MoCA) questionnaire. The total score ranges from 0 to 30 points. The MoCA is divided into 7 subscores: visuospatial/executive (5 points); naming (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points). One point is added if the subject has ≤12 years of education. A total of 30 points may be given. A score ≤25 indicates some degree of cognitive impairment.
Depression
Time frame: 10 minutes
Depression will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a depressive state (borderline abnormal). A score of 11-21 points indicates a probable presence of a depressive state (abnormal).
Anxiety
Time frame: 10 minutes
Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a state of anxiety (borderline abnormal). A score of 11-21 points indicates a probable presence of an anxiety disorder (abnormal).
Allodynia
Time frame: 10 minutes
Allodynia will be assessed using Allodynia Symptom Checklist (ASC-12) questionnaire. The total score ranges from 0-24 points. A score of 0-2 suggests no allodynia. A score of 3-5 suggests mild allodynia. A score of 6-8 suggests moderate allodynia. A score of 9 or more suggests severe allodynia.
Post-Traumatic Stress Disorder
Time frame: 10 minutes
Post-traumatic stress disorder will be assessed using Harvard Trauma Questionnaire (HTQ). The total score ranges from 16-64. The total score is divided with 16 and a clinical cut-off score of 2.5 is set to be indicative of PTSD.
Quality of Sleep: Pittsburgh Sleep Quality Index (PSQ-I)
Time frame: 10 minutes
Quality of Sleep will be assessed using Pittsburgh Sleep Quality Index (PSQ-I). The measure consists of 19 individual items, creating 7 components that produce one global score. The total PSQ-I score ranges from 0 to 21 with lower scores indicating a healthier sleep quality.
Muscle Tenderness
Time frame: 10 minutes
Muscle tenderness will be assessed using Total Tenderness Score (TTS). The total score ranges from 0-48 with higher scores indicating a higher degree of muscle tenderness.
Pressure Pain Threshold
Time frame: 10 minutes
Pressure Pain Threshold will be assessed using an Algometer.
Cortical Density
Time frame: 10 minutes
Cortical density will be assessed using Voxel-Based Morphometry.
Cortical Thickness
Time frame: 10 minutes
Cortical thickness will be assessed using Surface-Based Morphometry
Number and Location of Microhemorrhages
Time frame: 6 minutes
The number and location of microhemorrhages will be assessed using Susceptibility-Weighted Imaging.
White Matter Structural Fiber Integrity
Time frame: 10 minutes
The white matter structural fiber integrity will be assessed using Diffusion Tensor Imaging
Number and Location of White Matter Lesions
Time frame: 6 minutes
The number and location of white matter lesions will be assessed using T2-weighted Fluid-Attenuated Inversion Recovery.
Cerebral Blood Flow
Time frame: 7 minutes
Cerebral blood flow will be assessed using arterial spin labelling (ASL).
Brain Network Functional Connectivity
Time frame: 11 minutes
Brain network functional connectivity will be assessed using blood oxygen level-dependent functional magnetic resonance imaging.
Incidence of Headache Exacerbation with Migraine-Like Features
Time frame: 60 minutes
Migraine-like features are defined as headache fulfilling at least two of the following four characteristics: 1. Unilateral location 2. Pulsating quality 3. Moderate or severe pain intensity 4. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) And during headache at least one of the following must be fulfilled: 1. Nausea and/or vomiting 2. Photophobia and phonophobia 3. Headache mimicking the usual exacerbated headache with migraine-like features If the participant fulfills these criteria at baseline, then incidence of exacerbated headache with migraine-like features is defined as: - An increase in headache intensity combined with an increase in the degree nausea and/or photophobia and phonophobia (based on a mild / moderate / severe scale)
Headache Area under the Curve
Time frame: 12 hours
Headache area under the curve is defined as headache intensity x duration up to 12 h after CGRP infusion
Time to Maximum Headache
Time frame: 12 hours
Time to maximum headache score on CGRP day compared to placebo day will be assessed using a headache questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 40255022Schytz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Schytz, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitonin Gene-Related Peptide in people with Post-Traumatic Headache and Concussion, Mild, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Characteristics (time frame: 50 minutes). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.