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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575639
Other study ID # PREDIS
Secondary ID
Status Completed
Phase Phase 3
First received April 9, 2012
Last updated April 7, 2013
Start date February 2012
Est. completion date March 2013

Study information

Verified date April 2013
Source Lady Hardinge Medical College
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

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


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 24 Months
Eligibility Inclusion Criteria:

- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants

Exclusion Criteria:

1. Children with active systemic illness

2. Children with evidence of active tuberculosis

3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference < 11 cm/pedal edema/Weight for height < 3 SD)

4. Children with recurrent illness/chronic systemic illness

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Oral prednisolone
Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day

Locations

Country Name City State
India Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . 14 days No
Secondary Proportion of children with adverse effects 14 days Yes
See also
  Status Clinical Trial Phase
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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
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 NCT01723787 - Genetic Studies in Patients and Families With Infantile Spasms
Completed NCT02092883 - Evaluation of Neuroinflammation in Children With Infantile Spasms Phase 4
Withdrawn NCT01413711 - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Phase 4
Terminated NCT00442104 - Open-label Extension to Protocol 1042-0500 Phase 2
Completed NCT00441896 - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms 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