Prednisolone for Infantile Spasms

Overseen ByAngela L. Martinez

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must be taking: Prednisolone, ACTH, Vigabatrin

Must not be taking: Artisanal cannabinoids

Disqualifiers: Hypertension, Infection, Ketogenic diet, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on a ketogenic diet or have recently used artisanal cannabinoid products. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Prednisolone for treating infantile spasms?

Research shows that high-dose oral prednisolone is an effective treatment for infantile spasms, with studies indicating it can be used as a first-line hormonal therapy. It has been used successfully in many patients, and some studies suggest it can be an alternative to other hormonal treatments like ACTH (adrenocorticotropic hormone).¹ ² ³ ⁴ ⁵

Is prednisolone safe for treating infantile spasms?

Research shows that prednisolone has been used safely in treating infantile spasms, with studies evaluating its safety and effectiveness over many years. While it is generally considered safe, as with any medication, there may be side effects, and it's important to discuss these with a healthcare provider.¹ ³ ⁴ ⁶ ⁷

How does the drug prednisolone differ from other treatments for infantile spasms?

Prednisolone is a high-dose oral corticosteroid that offers a less expensive and more accessible alternative to the traditional intramuscular ACTH treatment for infantile spasms. It has been shown to be effective in achieving spasm freedom with fewer side effects and at a significantly lower cost compared to ACTH.² ³ ⁴ ⁸ ⁹

What is the purpose of this trial?

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.

Research Team

Shaun A. Hussain, MD, MS

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for infants aged 2 to 18 months who have been diagnosed with infantile spasms syndrome and showed a complete response to standard treatment. It's not suitable for those outside this age range or without EEG-confirmed recovery.

Inclusion Criteria

My child is between 2 to 18 months old.

My infantile spasms responded completely to standard treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose prednisolone or placebo for 4 months

4 months

Monthly visits with clinic and EEG evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final evaluation at age 2 years

Up to age 2 years

Final visit at age 2 years

Treatment Details

Interventions

Prednisolone

Trial Overview The study tests if low-dose prednisolone can safely prevent relapse in children who've responded well to initial treatments for infantile spasms, compared with a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Low-dose prednisoloneActive Control2 Interventions

Prednisolone and famotidine.

Group II: PlaceboPlacebo Group1 Intervention

Placebo (prednisolone) and placebo (famotidine)