NCT06503328 Role of Specific microRNAs in Cluster Headache
| NCT ID | NCT06503328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
| Condition | Cluster Headache |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-03-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cluster headache (CH) is a primary headache included in the trigeminal autonomic cephalalgias (TACs) according to the International Calssification of Headache Disorder, Third Edition. CH is characterized by a multifaceted and incompletely understood pathophysiology. Recent experimental evidence has increasingly emphasized the role of specific microRNAs (miRNAs) in the pathophysiology of primary headaches, including migraine. In a recent study, we observed an upregulation in the gene expression of two miRNAs, miR-382-5p and miR-34a-5p, in peripheral blood mononuclear cells (PBMCs) of subjects with chronic migraine (CM). These miRNAs are involved in inflammation modulation and the release of γ-aminobutyric acid (GABA). Notably, this upregulation correlated with the migraine phenotype and its severity. Several neuropeptides have been established to play an active role in CH. Studies by the Danish group have demonstrated that intravenous administration of CGRP, PACAP, or VIP can induce CH attacks in at least 50% of participants in the active phase of the disease. However, no data currently exists regarding the potential involvement of miRNAs in CH. Given this context, the primary aim of this study is to investigate the gene expression of specific miRNAs (miR-382-5p, miR-34a-5p, and miR-155) in PBMCs and plasma levels of neuropeptides (CGRP, PACAP, VIP) in subjects with episodic CH in the active phase (eCH-act), episodic CH in the remission phase (eCH-rem), chronic CH (cCH), and healthy control subjects (HCs).
Eligibility Criteria
\- Healthy Controls Inclusion Criteria: * age between \>18 and \<65 years Exclusion Criteria: * diagnosis of primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension type headache is allowed) * diagnosis of neurological disorders * diagnosis of medical conditions considered clinically relevant by the researcher * pregnant and lactating women * taking NSAIDs, triptans or opiates in the previous 24 hours * Episodic Cluster Headache Inclusion Criteria: * diagnosis of Episodic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) * age between \>18 and \<65 years of both genders Exclusion Criteria: * concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) * diagnosis of other neurological disorders * diagnosis of medical conditions considered clinically relevant by the researcher * diagnosis of chronic pain syndrome of any nature * pregnant and lactating women * use of substances of abuse * Chronic Cluster Headache Inclusion Criteria: * diagnosis of Chronic Cluster Headache according to ICHD-III criteria (at least 1 year at screening) * age between \>18 and \<65 years of both genders Exclusion Criteria: * concomitant diagnosis of other primary and/or secondary headache according to ICHD-III criteria (only diagnosis of sporadic tension headache is allowed) * diagnosis of other neurological disorders * diagnosis of medical conditions considered clinically relevant by the researcher * diagnosis of chronic pain syndrome of any nature * pregnant and lactating women * use of substances of abuse
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06503328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cluster Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06503328 currently recruiting?
Yes, NCT06503328 is actively recruiting participants. Contact the research team at roberto.deicco@mondino.it for enrollment information.
Where is the NCT06503328 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06503328 clinical trial?
NCT06503328 is sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. The trial plans to enroll 100 participants.