NCT06741358 Using Glialia for Treating Persistent Perceptual Postural Dizziness
| NCT ID | NCT06741358 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Persistent Postural Perceptual Dizziness |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-21 |
| Primary Completion | 2025-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-12-21 with a primary completion date of 2025-10-10.
⚠ 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
This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.
Eligibility Criteria
Inclusion criteria for all groups: -Age between 18 and 65 years. Inclusion criteria for the PPPD-glialia group: * Diagnosis of PPPD; * Recovery from COVID-19 infection or absence of previous infection. Inclusion criteria for the PPPD-placebo group: * Diagnosis of PPPD; * Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group). Exclusion criteria for all PPPD-group: * Presence of concurrent neurological and otological disorders other than PPPD; * Pregnant women. Inclusion criteria for the control group: -Previous COVID-19 infection (matched for timing to the PPPD-glialia group). Exclusion criteria for the control group: * Presence of neurological and otological disorders; * Pregnant women.
Contact & Investigator
Iole Indovina, PhD
PRINCIPAL INVESTIGATOR
Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy ; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.
Frequently Asked Questions
Who can join the NCT06741358 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Persistent Postural Perceptual Dizziness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06741358 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06741358 currently recruiting?
Yes, NCT06741358 is actively recruiting participants. Contact the research team at i.indovina@hsantalucia.it for enrollment information.
Where is the NCT06741358 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06741358 clinical trial?
NCT06741358 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The principal investigator is Iole Indovina, PhD at Department of Systems Medicine, University of Rome Tor Vergata Rome, Italy ; Centre of Space Bio-medicine, University of Rome Tor Vergata Rome, Italy ; Laboratory of Neuromotor Physiology, IRCCS Santa Lucia Foundation Rome, Italy.. The trial plans to enroll 30 participants.