NCT06819670 A Study to Prevent Infantile Spasms Relapse
| NCT ID | NCT06819670 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Infantile Spasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2028-02-28 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-05-05 with a primary completion date of 2028-02-28.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 2 to 18 months, inclusive 2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin) Exclusion Criteria: 1. 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 2. Exposure to any artisanal cannabinoid product within 14 days of screening 3. Ongoing therapy with the ketogenic diet 4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening 5. Treatment of IESS via epilepsy surgery
Contact & Investigator
Shaun A. Hussain, MD, MS
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06819670 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 18 Months, studying Infantile Spasms. 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 NCT06819670 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06819670 currently recruiting?
Yes, NCT06819670 is actively recruiting participants. Contact the research team at shussain@mednet.ucla.edu for enrollment information.
Where is the NCT06819670 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06819670 clinical trial?
NCT06819670 is sponsored by University of California, Los Angeles. The principal investigator is Shaun A. Hussain, MD, MS at University of California, Los Angeles. The trial plans to enroll 40 participants.