Investigating the role of microRNAs in cluster headache
Role of Specific microRNAs in Cluster Headache: Implications for Disease Phenotype and Neuropeptide Expression
This study is trying to see if certain tiny molecules in the blood are linked to cluster headaches and how they might affect pain and inflammation in people who have these headaches.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06503328 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the involvement of specific microRNAs, particularly miR-34a-5p and miR-382-5p, in the pathophysiology of cluster headaches. By analyzing peripheral blood mononuclear cells from participants diagnosed with episodic cluster headache, the study seeks to understand how these microRNAs may influence inflammation and pain modulation. The research will include healthy controls and individuals with a confirmed diagnosis of episodic cluster headache, while excluding those with other headache disorders or relevant medical conditions. The findings could provide insights into the molecular mechanisms underlying cluster headaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of episodic cluster headache.
Not a fit: Patients with chronic headache disorders or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new biomarkers for cluster headache and potential therapeutic targets.
How similar studies have performed: While the role of microRNAs in headache disorders is an emerging field, previous studies have shown promising results in related areas, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia
- IRCCS Mondino Foundation — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Roberto De Icco, MD, PhD
- Email: roberto.deicco@mondino.it
- Phone: 00390382380387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.