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A Novel Approach to Infantile Spasms

NCT03347526 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2021-05-27

No results posted yet for this study

Summary

This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).

Conditions

  • Infantile Spasm

Interventions

DRUG

Cosyntropin Injectable Suspension, 1 mg/mL

Injectable

DRUG

Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin

Injectable + oral solution

DRUG

Vigabatrin

oral

Sponsors & Collaborators

  • Pediatric Epilepsy Research Foundation

    collaborator UNKNOWN

  • West Therapuetics, Inc

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kelly G. Knupp, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2021-06-30
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347526 on ClinicalTrials.gov