Primary Headache DisorderNCT05760625
Gender Differences and Features of the Clinical Course of Primary Headaches
An observational study of Primary Headache Disorder, run by Tashkent Medical Academy at 1 site in Uzbekistan.
Trial summary
The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Headache Disorder
- What is being tested?
- analysis BDNF
- How many people
- 120 participants
- Where
- 1 siteUzbekistan
- Study dates
- 10 Dec 2020to 21 Mar 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients, males and females, were included if they consented to study participation, and were aged between 18 and 45 years
Who may be able to join
- Migraine patients were included if they suffered from at least one, but no more than eight migraine attacks per month, and had not taken any pain medication including non-steroidal anti inflammatory drugs (NSAIDs), triptans or opioids 48 h prior to blood sample collection and if phone contact was possible 3 days after blood sampling.
Who cannot join
- Patients were not included if they had a history of cardio or cerebrovascular disease, diabetes, cancer, severe renal or hepatic disease. Patients with more than one diagnosis of a primary headache, i.e. coexistent migraine and tension-type headache, were excluded from study participation. Pregnancy and breastfeeding were additional exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Tashkent Medical Academy
Tashkent, Olmazor District, 100109
About this study
The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs. BDNF is a member of the neurotrophin family and has been recognized as an important modulator of nociceptive pathways. Interestingly, BDNF is co-expressed with CGRP in trigeminal ganglion neurons. CGRP is one of the key molecules in migraine and cluster headache pathogenesis. BDNF is an important marker of neuronal plasticity. It has also been associated with pain processing. Increased BDNF levels are observed in chronic pain syndromes. In order to understand the role of BDNF associated with other factors such as gender on headache attacks we aimed to determine whether migraine and cluster headache is correlated with brain derived neurotrophic factor (BDNF) level, gender and age.
Read the detailed description
Patients will recruite among those attending the Clinic of Tashkent Medical Academy, Uzbekistan. Three groups of headache patients will be enrolled in this prospective study: patients with episodic migraine with and without aura, episodic cluster headache, and frequent episodic tension-type headache according to the current criteria of the International Headache Society. In migraineurs, venous blood samples will be collected twice: outside and during migraine attacks prior to pain medication. In cluster headache patients serum samples will be collected in and outside cluster bout. Analysis of BDNF will performed using enzyme-linked immunosorbent assay technique. In patients with tension-type headache (outside attack) and healthy controls, one single blood sample will take.Patients with a history of cardiovascular disease, major depression, hypertension, drug or alcohol abuse, or other apparent diseases will be excluded from the study. The research will comprise 120 patients (males and females) suffering from primary headache. At the moment we started collecting patients.
- Conditions
- Primary Headache Disorder
- Being tested
- analysis BDNF
- Keywords
- migraine, pain, attack, BDNF, neurotrophins
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis BDNFDiagnostic test
We analysed consentration of BDNF in venous blood of patient with primary headache
| Study group | Role | What they receive |
|---|---|---|
| Migraine | In migraineurs, venous blood samples will be collected twice: outside and during migraine attacks prior to pain medication. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. Receives: Diagnostic Test: analysis BDNF | |
| Tension type of headache | In patients with tension-type headache (outside attack) and healthy controls, one single blood sample will take. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. Receives: Diagnostic Test: analysis BDNF | |
| Cluster headache | In cluster headache patients serum samples will be collected in and outside cluster bout. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. Receives: Diagnostic Test: analysis BDNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender differences and features of the clinical course of primary headaches
Increasing of BDNF during headache attacks in women were more than men
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Dec 2020
- Primary completion20 Oct 2022
- Study completion21 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Headache DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tashkent Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahtigul Holmuratova, Tashkent Medical Academy
- Investigators
- Bahtigul Holmuratova, PhD student, Study chair, Tashkent Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760625
- Sponsor's protocol ID
- 616.857-036:616.831:615.21
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences and Features of the Clinical Course of Primary Headaches
- ClinicalTrials.gov ID
- NCT05760625
- Acronym / sponsor ID
- 616.857-036:616.831:615.21
- Conditions
- Primary Headache Disorder
- Keywords
- migraine, pain, attack, BDNF, neurotrophins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tashkent Medical AcademyUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 21 Mar 2023 (estimated)
- First posted
- 8 Mar 2023 (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.
The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs. BDNF is a member of the neurotrophin family and has been recognized as an important modulator of nociceptive pathways. Interestingly, BDNF is co-expressed with CGRP in trigeminal ganglion neurons. CGRP is one of the key molecules in migraine and cluster headache pathogenesis. BDNF is an important marker of neuronal plasticity. It has also been associated with pain processing. Increased BDNF levels are observed in chronic pain syndromes. In order to understand the role of BDNF associated with other factors such as gender on headache attacks we aimed to determine whether migraine and cluster headache is correlated with brain derived neurotrophic factor (BDNF) level, gender and age.
Detailed description
Patients will recruite among those attending the Clinic of Tashkent Medical Academy, Uzbekistan. Three groups of headache patients will be enrolled in this prospective study: patients with episodic migraine with and without aura, episodic cluster headache, and frequent episodic tension-type headache according to the current criteria of the International Headache Society. In migraineurs, venous blood samples will be collected twice: outside and during migraine attacks prior to pain medication. In cluster headache patients serum samples will be collected in and outside cluster bout. Analysis of BDNF will performed using enzyme-linked immunosorbent assay technique. In patients with tension-type headache (outside attack) and healthy controls, one single blood sample will take.Patients with a history of cardiovascular disease, major depression, hypertension, drug or alcohol abuse, or other apparent diseases will be excluded from the study. The research will comprise 120 patients (males and females) suffering from primary headache. At the moment we started collecting patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Migraine | – | Diagnostic Test: analysis BDNFIn migraineurs, venous blood samples will be collected twice: outside and during migraine attacks prior to pain medication. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. |
| Tension type of headache | – | Diagnostic Test: analysis BDNFIn patients with tension-type headache (outside attack) and healthy controls, one single blood sample will take. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. |
| Cluster headache | – | Diagnostic Test: analysis BDNFIn cluster headache patients serum samples will be collected in and outside cluster bout. Analysis of BDNF performed using enzyme-linked immunosorbent assay technique. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients, males and females, were included if they consented to study participation, and were aged between 18 and 45 years
Key inclusion criteria (1 listed)
- Migraine patients were included if they suffered from at least one, but no more than eight migraine attacks per month, and had not taken any pain medication including non-steroidal anti inflammatory drugs (NSAIDs), triptans or opioids 48 h prior to blood sample collection and if phone contact was possible 3 days after blood sampling.
Key exclusion criteria (1 listed)
- Patients were not included if they had a history of cardio or cerebrovascular disease, diabetes, cancer, severe renal or hepatic disease. Patients with more than one diagnosis of a primary headache, i.e. coexistent migraine and tension-type headache, were excluded from study participation. Pregnancy and breastfeeding were additional exclusion criteria.
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 |
|---|---|---|
| analysis BDNFWe analysed consentration of BDNF in venous blood of patient with primary headache | Diagnostic test | Cluster headache, Migraine, Tension type of headache |
Primary outcome
Gender differences and features of the clinical course of primary headaches
Time frame: 2 years
Increasing of BDNF during headache attacks in women were more than men
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No. The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs.
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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.
Bahtigul Holmuratova, PhD student study chair
Tashkent Medical Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Headache Disorder, run by Tashkent Medical Academy at 1 site in Uzbekistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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 Uzbekistan. 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. 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?
Results are not available in the source record.
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?
Gender differences and features of the clinical course of primary headaches (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2023.