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)

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• Spasms, Infantile 47
• Recurrence 3,523

Keywords

• Randomized controlled trial
• Spasms, Infantile
• Prednisolone
• Infant
• Electroencephalography
• Child Development
• Relapse
• Tapering Regimen
• Treatment Duration

Spasms, Infantile

47 studies on the registry are indexed under Spasms, Infantile; 8 are open to participants now.

This study's planned enrollment of 182 is above the median of 40 across 33 interventional studies indexed under Spasms, Infantile.

Lead sponsor

University of Colombo is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  treatment arm A

  The initial phase of the intervention involves administering prednisolone orally at a dosage of 10 mg, four times daily (40 mg/day) for 7 days. This will be followed by a tapering regimen over 15 days (\~2 weeks) as outlined below: 10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days The second phase of the intervention begins at the end of 15 days, where a prolonged tapering of prednisolone at a low dose (\<0.4 mg/kg per day) will be administered as 10 mg once daily, twice a week, for an additional 10 weeks.

  Drug: Short-Duration Oral Prednisolone with Extended Tapering

• Active comparator
  treatment arm B

  Prednisone will be administered orally at a dose of 10 mg, four times daily (40 mg/day) for 14 days. This is the standard therapy currently given to children with IESS in Sri Lanka. This will be followed by a tapering regimen over 15 days (\~2 weeks) as outlined below: 10 mg three times daily - 5 days 10 mg twice daily - 5 days 10 mg daily - 5 days No additional tapering will be implemented.

  Drug: Standard Oral Prednisolone Regimen with Tapering

Interventions

• DrugShort-Duration Oral Prednisolone with Extended Tapering

  In treatment arm A, oral prednisolone will be administered in tablet form (5 mg strength) as follows: an initial phase of 10 mg four times daily (total 40 mg/day) for 7 days, followed by a 15-day tapering phase-10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. After tapering, a prolonged low-dose maintenance phase will be implemented, where 10 mg is given once daily twice a week for an additional 10 weeks. This regimen is designed to test whether a shorter high-dose course, combined with extended low-dose maintenance, can provide equivalent control of infantile epileptic spasms syndrome while reducing the adverse effects associated with longer high-dose therapy, compared to the standard 14-day high-dose regimen (treatment arm B).

• DrugStandard Oral Prednisolone Regimen with Tapering

  Prednisone oral tablets, 10 mg, administered four times daily (40 mg/day) for 14 days, followed by a tapering phase over 15 days: 10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. No further tapering will be implemented after the initial 14-day treatment period. This regimen represents the standard therapy for Infantile Spasms in Sri Lanka.

Primary outcomes

1. Electroclinical Remission at Day 14 and Day 28

   This primary outcome measure compares the efficacy of the 7-day versus 14-day oral prednisolone regimens. Electroclinical remission is defined as (1) spasm control-no clinically recognizable spasms for a minimum of 24 consecutive hours as recorded by the caregiver-and (2) EEG remission-disappearance of hypsarrhythmia with the BASED score improved to 3 or less on a standardized 30-minute sleep EEG (with 5 minutes of wakefulness).

   Time frame: Assessed at 14 days and 28 days after treatment initiation.

Secondary outcomes

1. Long-Term Spasm Control

   This measure evaluates sustained spasm control by documenting the absence of any visible spasms (as observed by caregivers) for at least 72 hours on the day of assessment. It is used to compare the durability of the two treatment regimens over an extended follow-up period.

   Time frame: Assessed at 42 days, 3 months, 6 months, and 12 months post-treatment.

2. Spasm Relapse Rate and Time to Relapse

   This outcome captures the relapse rate, defined as the reappearance of clinical spasms in conjunction with the return of hypsarrhythmia on EEG (BASED score of 4 or above), after initial remission. It also records the duration of spasm freedom until the first relapse, providing information on both the frequency and timing of relapse events.

   Time frame: Evaluated continuously over the 12-month follow-up period.

3. Developmental Outcome at 24 Months

   Neurodevelopmental progress is assessed using the Bayley Scales of Infant and Toddler Development (3rd edition). The measure records deviations from the normative mean (100) across domains (cognition, language, motor skills, social-emotional, and adaptive behavior) and examines correlations with spasm control and relapse status between the treatment arms.

   Time frame: Assessed at 24 months following treatment initiation.

4. Evolution of Epilepsy

   This outcome measure tracks the emergence or evolution of other seizure types or epilepsy syndromes beyond infantile spasms. Epilepsy is defined as the occurrence of two or more unprovoked seizures (other than spasms) in a previously spasm-free child. Comparisons between treatment groups will provide insight into long-term seizure evolution.

   Time frame: Assessed at 12 months post-treatment.

Individual participant data

Plan to share: No — Since this clinical trial involves infants, who belong to a vulnerable population, strict ethical considerations have been incorporated to ensure data confidentiality and participant protection. All collected data will remain confidential and will be stored securely in a password-protected computer and locked storage, accessible only to the investigators. There is no plan to share individual participant data (IPD).