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A Study to Prevent Infantile Spasms Relapse

NCT ID: NCT06819670

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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In this study, the investigators will enroll infants who have responded to standard therapy for treatment of Infantile Epileptic Spasms Syndrome (IESS). Patients will be randomized to receive either low-dose prednsiolone or placebo for 4 months. During the first 7 months, patients will be evaluated monthly, with clinic visits and electroencephalography (EEG). Patients will then return for a final visit at age 2 years. Key outcomes will be determination of IESS relapse, emergence of other types of seizures/epilepsy, and evaluation of developmental/behavioral status at age 2 years. We will attempt to determine whether or not the prednisolone intervention reduces the risk of any adverse outcome, but this may not be possible given the study design. We will also evaluate the feasibility of the intervention, study procedures, and recruitment.

Conditions

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Infantile Spasms Infantile Epileptic Spasms Syndrome West Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Prednisolone (1 mg/kg/day) or placebo AND famotidine (1 mg/kg/day) or placebo. Both medications will be administered daily for 4 months, followed by a 1-month taper
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low-dose prednisolone

Prednisolone and famotidine.

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

active drug

Famotidine

Intervention Type DRUG

active drug

Placebo

Placebo (prednisolone) and placebo (famotidine)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

non-active drug

Interventions

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Prednisolone

active drug

Intervention Type DRUG

Famotidine

active drug

Intervention Type DRUG

Placebo

non-active drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Epilepsy Research Foundation

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Shaun Hussain, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaun A. Hussain, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shaun A. Hussain, MD, MS

Role: CONTACT

[email protected]
310-206-7630

Angela L. Martinez

Role: CONTACT

[email protected]
310-206-7630

Facility Contacts

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Angela Martinez

Role: primary

[email protected]
3102067630

References

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Hussain SA. Treatment of infantile spasms. Epilepsia Open. 2018 Oct 23;3(Suppl Suppl 2):143-154. doi: 10.1002/epi4.12264. eCollection 2018 Dec.

Reference Type BACKGROUND
PMID: 30564773 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30564773/

Related Info

Other Identifiers

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20224426

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-001710

Identifier Type: -

Identifier Source: org_study_id

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