Infantile SpasmsPhase 2NCT06819670
A Study to Prevent Infantile Spasms Relapse
A Phase 2 study testing Prednisolone and Famotidine in people with Infantile Spasms and Infantile Epileptic Spasms Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 months
- Conditions the study is for
- Infantile Spasms, Infantile Epileptic Spasms Syndrome, West Syndrome
- What is being tested?
- Prednisolone and Famotidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
- Exposure to any artisanal cannabinoid product within 14 days of screening
- Ongoing therapy with the ketogenic diet
- Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
- Treatment of IESS via epilepsy surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Angela Martinez, 3102067630, angelamartinez@mednet.ucla.edu
Shaun Hussain, MD, MS
About this study
Official title: A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
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.
Read the detailed description
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.
- Being tested
- Prednisolone, Famotidine, Placebo
- Keywords
- Relapse, Infantile Spasms, Prednisolone
- Medical subject headings
- Spasms, Infantile, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
active drug
FamotidineDrug
active drug
PlaceboDrug
non-active drug
| Study group | Role | What they receive |
|---|---|---|
| Low-dose prednisolone | Active comparator | Prednisolone and famotidine. Receives: Drug: Prednisolone; Drug: Famotidine |
| Placebo | Placebo comparator | Placebo (prednisolone) and placebo (famotidine) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
The investigators will tabulate of adverse events and determine whether any adverse event is associated with prednisolone treatment during the first 5 months of the study.
Measured: From enrollment to 5-month visit.
Incidence of epileptic spasms relapse
The investigators will record whether or not study participant experience a relapse of epileptic spasms during the study. Relapse is classified as present or absent and based on interpretation of EEG.
Measured: From enrollment to last evaluation at age 2 years
Secondary outcomes (2)
Incidence of autism spectrum disorder
At the final study visit, the investigators will use DSM-V criteria to determine if study participants fulfill diagnostic criteria for autism spectrum disorder.
Measured: From enrollment to last evaluation at age 2 years
Developmental/Behavioral Level
At the final study visit at age 2 years, the investigators will measure adaptive behavior using the Vineland-3 questionnaire.
Measured: From enrollment to last evaluation at age 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start5 May 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile SpasmsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Epilepsy Research Foundation
- Responsible party
- Principal investigator, Shaun Hussain, MD, University of California, Los Angeles
- Investigators
- Shaun A. Hussain, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819670
- Sponsor's protocol ID
- 22-001710
- Other IDs
- 20224426
- Status last verified
- May 2025
- First submitted
- 29 Jan 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data will be shared with other researchers upon reasonable request, after publication of results.
Publications
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.
PubMed 30564773
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
- ClinicalTrials.gov ID
- NCT06819670
- Acronym / sponsor ID
- 22-001710
- Keywords
- Relapse, Infantile Spasms, Prednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Pediatric Epilepsy Research Foundation
- Study start
- 5 May 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low-dose prednisolone | Active comparator | Drug: Prednisolone, Drug: FamotidinePrednisolone and famotidine. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (prednisolone) and placebo (famotidine) |
Who may qualify
- Ages
- 2 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
- Exposure to any artisanal cannabinoid product within 14 days of screening
- Ongoing therapy with the ketogenic diet
- Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
- Treatment of IESS via epilepsy surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoloneactive drug | Drug | Low-dose prednisolone |
| Famotidineactive drug | Drug | Low-dose prednisolone |
| Placebonon-active drug | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: From enrollment to 5-month visit.
The investigators will tabulate of adverse events and determine whether any adverse event is associated with prednisolone treatment during the first 5 months of the study.
Incidence of epileptic spasms relapse
Time frame: From enrollment to last evaluation at age 2 years
The investigators will record whether or not study participant experience a relapse of epileptic spasms during the study. Relapse is classified as present or absent and based on interpretation of EEG.
2 secondary outcomes
Incidence of autism spectrum disorder
Time frame: From enrollment to last evaluation at age 2 years
Developmental/Behavioral Level
Time frame: From enrollment to last evaluation at age 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 30564773Hussain SA. Treatment of infantile spasms. Epilepsia Open. 2018 Oct 23;3(Suppl Suppl 2):143-154. doi: 10.1002/epi4.12264. eCollection 2018 Dec.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified study data will be shared with other researchers upon reasonable request, after publication of results.
Related trials for Infantile Spasms
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A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
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RecruitingObservational study
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
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Active, not recruitingPhase 4
Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)
Spasms, Infantile, Prednisolone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun A. Hussain, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone and Famotidine in people with Infantile Spasms and Infantile Epileptic Spasms Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaun A. Hussain, MD, MS (310-206-7630, shussain@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: From enrollment to 5-month visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06819670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.