Whether high dose oral pyridoxine as an add on therapy to standard therapy ACTH is safe and efficacious than standard therapy of ACTH alone in the treatment of infantile spasms

Effectiveness and Safety of high dose, Oral Pyridoxine as add on to ACTH versus ACTH therapy for Infantile Spasms: A randomised, Open-Label Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010742

Enrollment

Registered

2017-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Infantile spasm patients diagnosedclinicallyand byEEG Age3to18months

Interventions

Intervention1: Tablet Pyridoxine in combination with Inj ACTH: High dose oral pyridoxine at 300mg/kg/day for 2 weeks and in case of response to be continued for total 6 weeks Control Intervention1: St

Eligibility

Inclusion criteria

Inclusion criteria: Infantile spasm patients diagnosed clinically and by EEG Age 3to18 months

Exclusion criteria

Exclusion criteria: Proven/ suspected case of Tuberous Sclerosis b) Proven/suspected case of neurometabolic, neurodegenerative or any other progressive disorder c) Previously treated patients with ACTH, oral steroids (within 28 days) and pyridoxine d) Contraindications to ACTH and pyridoxine therapy like cushingoid state, fever, diarrhea, hypertension e) Inability of parents/guardians to provide informed consent f) Inability of parents/guardians to provide data of outcome of spasms

Design outcomes

Primary

Measure	Time frame
Proportion of children with Complete cessation of spasmsTimepoint: 14-21 days,42-49 days and 90-104 days	—

Secondary

Measure	Time frame
Proportion of children who had reduction of frequency of epileptic spasms by more than 50% â?¢ Time taken to attain cessation of epileptic spasms (in days) after initiation of treatment with ACTH and high dose oral pyridoxine versus ACTH monotherapy â?¢ To determine improvement of development quotient (as assessed by Development assessment scale for Indian Infants, â?¢Safety by the side effect profile of the drugsTimepoint: 14-21 days, 42-49 days and 90-104 days;Proportion of children who are free of spasms Proportion of children who had reduction in frequency of epileptic spasms 50% Time taken for the cessation of spasms after initiation of therapy To assess the improvement in development quotient To asess the side effect profile of the patients on ACTH/ Pyridoxine Timepoint: 14-21 days, 42-49 days and 90-104 days	—

Measure

Time frame

Proportion of children who had reduction of frequency of epileptic spasms by more than 50% â?¢ Time taken to attain cessation of epileptic spasms (in days) after initiation of treatment with ACTH and high dose oral pyridoxine versus ACTH monotherapy â?¢ To determine improvement of development quotient (as assessed by Development assessment scale for Indian Infants, â?¢Safety by the side effect profile of the drugsTimepoint: 14-21 days, 42-49 days and 90-104 days;Proportion of children who are free of spasms Proportion of children who had reduction in frequency of epileptic spasms 50% Time taken for the cessation of spasms after initiation of therapy To assess the improvement in development quotient To asess the side effect profile of the patients on ACTH/ Pyridoxine Timepoint: 14-21 days, 42-49 days and 90-104 days

—

Countries

India

Contacts

Public ContactJitendra Kumar Sahu

PGIMER, Chandigarh

jsh2003@gmail.com7087009202

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026