Recruiting
Phase 2

Infantile Spasms

Sponsor:

UCLA

Code:

NCT06819670

Conditions

Infantile Spasms

Infantile Epileptic Spasms Syndrome

West Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Prednisolone

Famotidine

Placebo

Study Details

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.

Conditions

Infantile Spasms

Infantile Epileptic Spasms Syndrome

West Syndrome

Study ID

NCT06819670

Start date

May 5, 2025

Status verified date

May, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Low-dose prednisolone

Prednisolone and famotidine.

placebo comparator: Placebo

Placebo (prednisolone) and placebo (famotidine)

Interventions

Prednisolone

active drug

Famotidine

active drug

Placebo

non-active drug

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: From enrollment to 5-month visit. ]
  • Incidence of epileptic spasms relapse [ Time Frame: From enrollment to last evaluation at age 2 years ]

Central Contacts and Locations

Central contacts

Shaun A. Hussain, MD, MS

310-206-7630shussain@mednet.ucla.edu

Angela L. Martinez

310-206-7630angelamartinez@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Angela Martinez

3102067630angelamartinez@mednet.ucla.edu

Principal Investigator:

Shaun Hussain, MD, MS

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • Relapse
  • Infantile Spasms
  • Prednisolone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-05-08.