Preventing relapses in infants with spasms
A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
This study is testing if a low dose of prednisolone can help prevent relapses in infants with Infantile Epileptic Spasms Syndrome who have responded well to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 2 Months to 18 Months |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06819670 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of low-dose prednisolone in preventing relapse in infants diagnosed with Infantile Epileptic Spasms Syndrome (IESS) who have initially responded to standard treatments. Infants aged 2 to 18 months will be randomly assigned to receive either prednisolone or a placebo for four months, with monthly evaluations including clinic visits and EEG monitoring. The study will assess relapse rates, the emergence of other seizure types, and developmental outcomes at age two. The goal is to determine if prednisolone can reduce the risk of adverse outcomes associated with relapse.
Who should consider this trial
Good fit: Ideal candidates are infants aged 2 to 18 months who have been clinically diagnosed with IESS and have shown a complete response to standard therapy.
Not a fit: Patients with significant health issues, ongoing therapies that may interfere with the study, or those who have undergone epilepsy surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of relapse in infants with IESS, potentially improving long-term developmental outcomes.
How similar studies have performed: While there have been studies on treatments for IESS, the specific approach of using low-dose prednisolone to prevent relapse is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Shaun A. Hussain, MD, MS — University of California, Los Angeles
- Study coordinator: Shaun A. Hussain, MD, MS
- Email: shussain@mednet.ucla.edu
- Phone: 310-206-7630
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.