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Does adding oral Magnesium to standard treatment improve spasm control in children aged 2 24 months with Infantile Epileptic Spasm syndrome

Evaluation of efficacy of add on oral Magnesium to standard therapy in children with Infantile Epileptic Spasms Syndrome aged 2-24 months: Open-labelled randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104655
Enrollment
124
Registered
2026-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G40- Epilepsy and recurrent seizures

Interventions

Intervention1: Add-on Oral Magnesium Sulphate: Participants randomized to the intervention arm will receive oral magnesium sulphate as an add-on to standard therapy. Magnesium sulphate will be adminis

Sponsors

All India Institute of Medical Sciences, Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged between 2 and 24 months 2. Newly diagnosed cases of IESS as per ILAE 2022 diagnostic criteria 3. Parents willing to comply with the study protocol and follow up

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to magnesium sulphate 2. Known neuromuscular disorder 3. Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease 4. Caregivers not giving informed consent

Design outcomes

Primary

MeasureTime frame
The percentage of participants achieving spasm cessation at 4 weeks in the two groups, as determined from seizure diary.Timepoint: 4 weeks after initiation of therapy—

Secondary

MeasureTime frame
Change in spasm frequencyTimepoint: 2, 4 and 8 weeks;Change in Developmental Quotient (DQ) using DASIITimepoint: Baseline, 4 weeks;Change in Behavioural profile using Infant behavioural rating questionnaireTimepoint: Baseline, 4 weeks;Change in BASED score on EEGTimepoint: Baseline, 4 weeks;Change in serum magnesium levelsTimepoint: Baseline, 4 weeks;Nature and frequency of adverse effects observedTimepoint: 4 weeks—

Countries

India

Contacts

Public ContactDr Indar Kumar Sharawat

All India Institute of Medical Sciences, Rishikesh

sherawatdrindar@gmail.com9560182301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026