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Status unknownNCT05760625Updated Mar 8, 2023

Gender Differences and Features of the Clinical Course of Primary Headaches

An observational study in Primary Headache Disorder, sponsored by Tashkent Medical Academy. Status unknown at 1 site in Uzbekistan. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Tashkent Medical Academy · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 45 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Primary Headache Disorder

Keywords

  • migraine
  • pain
  • attack
  • BDNF
  • neurotrophins
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In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

This is the only study on the registry with Tashkent Medical Academy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients, males and females, were included if they consented to study participation, and were aged between 18 and 45 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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.

    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.

    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.

    Diagnostic Test: analysis BDNF

Interventions

  • Diagnostic testanalysis BDNF

    We analysed consentration of BDNF in venous blood of patient with primary headache

06

What researchers measure

Primary outcomes

  1. Gender differences and features of the clinical course of primary headaches

    Increasing of BDNF during headache attacks in women were more than men

    Time frame: 2 years

07

Study locations

1 site
  • Tashkent Medical Academy
    Tashkent, Olmazor District 100109, Uzbekistan
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05760625
Lead sponsor
Tashkent Medical Academy
Responsible party
Bahtigul Holmuratova (Dr. Bahtigul, Tashkent Medical Academy) — Principal investigator
First posted
Mar 8, 2023
Start date
Dec 10, 2020
Primary completion
Oct 20, 2022
Completion
Mar 21, 2023 (estimated)
Last update
Mar 8, 2023

Study contacts

Bahtigul Holmuratova, PhD student
study chair · Tashkent Medical Academy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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