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Trial · Interventional

SuspendedPhase 3Registry data

A Novel Approach to Infantile Spasms

NCTNCT03347526 (opens ClinicalTrials.gov in a new tab)Other id17-0222
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This trial is suspended.

Reason given at the registry: Study on enrollment hold as a precaution per the pharmaceutical company.

Overview

Status
Suspended
Phase
Phase 3
Enrollment
394 participants (estimated)
Sponsor
University of Colorado, Denver · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
19 Apr 2018
Primary completion
Jun 2021 (estimated)
Completion
Aug 2021 (estimated)
First posted
20 Nov 2017
Last update posted
27 May 2021
Conditions
Infantile Spasm

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 3

    A Novel Approach to Infantile Spasms

    NCT03347526

    19 Apr 2018 to est. Aug 2021

    Suspended

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Cosyntropin Injectable Suspension, 1 mg/mLDrug
  • Cosyntropin Injectable Suspension 1 MG/ML + vigabatrinDrug
  • VigabatrinDrug

Arms3

  • Experimental

    Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin

  • Experimental

    Cosyntropin Injectable Suspension, 1 mg/mL

  • Active comparator

    Vigabatrin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).

    Time frame · 2 weeks

    Registry description

    a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.

Secondary outcomes(4)

  1. A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b)

    Time frame · Day 14-42

    Registry description

    a) Resolution of clinical spasms for 48 hours at 2 weeks sustained until day 42, and b) Resolution of hypsarrhythmia via video EEG at 2 weeks.

  2. A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.

    Time frame · 6 months

    Registry description

    Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.

  3. Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).

    Time frame · 18 months chronological age

    Registry description

    A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Adaptive Behavior Assessment System (ABAS III) at 18 months chronological age.

  4. Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).

    Time frame · 18 months chronological age

    Registry description

    A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on developmental scores as measured by the Vineland II at 18 months chronological age.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Months up to 2 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * New onset infantile spasms * Age \> 2 months * Age\< 2 years * Hypsarrhythmia on video-EEG * Normal renal function Exclusion Criteria: * Prior treatment given for infantile spasms * Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy * Absence of hypsarrhythmia * Inability for the parent or caregiver to provide consent * Inability for the parent or caregiver to complete seizure diary * Diagnosis of: * scleroderma, * osteoporosis, * recent systemic fungal infections, * ocular herpes simplex, * recent surgery, * history of or the presence of a peptic ulcer, * congestive heart failure, * uncontrolled hypertension

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