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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


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

See also
  Status Clinical Trial Phase
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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
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Completed NCT00552045 - Epilepsy Phenome/Genome Project
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
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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Withdrawn NCT01413711 - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Phase 4
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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Withdrawn NCT01549288 - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy Phase 2/Phase 3
Not yet recruiting NCT06315829 - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
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