NCT06819670RecruitingPhase 2
A Study to Prevent Infantile Spasms Relapse
A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 5 May 2025
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Epilepsy
- NCT number
- NCT06819670
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 5 May 2025 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing therapy with the ketogenic diet
Other illness
- Presence of clinically significant hypertension, infection, or any other diagnosis which poses unreasonable risk in the setting of extended corticosteroid therapy, in the view of the study physician
- Treatment of IESS via epilepsy surgery
Other
- Exposure to any artisanal cannabinoid product within 14 days of screening
- Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
Who the study is looking for
- Age 2 to 18 months, inclusive
- Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin)
Age in the registry: 2 months to 18 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.