Trial record 1 of 16 for:    "X-linked infantile spasm syndrome"
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Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Satinder Aneja, Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01575639
First received: April 9, 2012
Last updated: April 7, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Infantile Spasms
West Syndrome
Drug: Oral prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of children with adverse effects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose
Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days
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
Active Comparator: Usual dose
Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days
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

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575639

Locations
India
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Principal Investigator: Satinder Aneja, MD Lady Hardinge Medical College
  More Information

No publications provided

Responsible Party: Satinder Aneja, Director Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01575639     History of Changes
Other Study ID Numbers: PREDIS
Study First Received: April 9, 2012
Last Updated: April 7, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014