Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Status Completed

Clinical Trial Summary

Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01575639
Study type	Interventional
Source	Lady Hardinge Medical College
Contact
Status	Completed
Phase	Phase 3
Start date	February 2012
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02299115` - Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms	Phase 3
Completed	`NCT02885389` - Molecular Genetics in Infantile Spasms	N/A
Completed	`NCT01006811` - Use of the Modified Atkins Diet in Infantile Spasms	Phase 2/Phase 3
Completed	`NCT01828437` - Addition of Pyridoxine to Prednisolone in Infantile Spasms	Phase 3
Recruiting	`NCT01858285` - Genetics of Epilepsy and Related Disorders
Completed	`NCT00552045` - Epilepsy Phenome/Genome Project
Not yet recruiting	`NCT06315829` - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Completed	`NCT02220114` - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy	N/A
Completed	`NCT02954887` - Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)	Phase 3
Completed	`NCT02092883` - Evaluation of Neuroinflammation in Children With Infantile Spasms	Phase 4
Completed	`NCT01723787` - Genetic Studies in Patients and Families With Infantile Spasms
Withdrawn	`NCT01413711` - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms	Phase 4
Completed	`NCT00441896` - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms	Phase 2
Terminated	`NCT00442104` - Open-label Extension to Protocol 1042-0500	Phase 2
Withdrawn	`NCT01549288` - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy	Phase 2/Phase 3
Completed	`NCT01073579` - Sabril Patient Registry	N/A
Completed	`NCT02953548` - Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)	Phase 3
Completed	`NCT00001325` - Metabolic Abnormalities in Children With Epilepsy	N/A
Completed	`NCT00968136` - Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study	N/A