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A Novel Approach to Infantile Spasms

Primary Purpose

Infantile Spasm

Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cosyntropin Injectable Suspension, 1 mg/mL
Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Vigabatrin
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Spasm focused on measuring Vigabatrin, Cosyntropin

Eligibility Criteria

2 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • UCSF Medical Center
  • University of Colorado Anschutz Medical Campus
  • Children's National Medical Center
  • Children's Healthcare of Atlanta at Scottish Rite
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Boston Children's Hospital
  • C.S. Mott Children's Hospital
  • Mayo Clinic
  • Montefiore Medical Center
  • Columbia University Medical Center
  • Atrium Health
  • Oregon Health and Science University
  • Cook Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin

Cosyntropin Injectable Suspension, 1 mg/mL

Vigabatrin

Arm Description

Outcomes

Primary Outcome Measures

A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.

Secondary Outcome Measures

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)
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.
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
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.
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
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.

Full Information

First Posted
November 15, 2017
Last Updated
May 26, 2021
Sponsor
University of Colorado, Denver
Collaborators
Pediatric Epilepsy Research Foundation, West Therapuetics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03347526
Brief Title
A Novel Approach to Infantile Spasms
Official Title
A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Suspended
Why Stopped
Study on enrollment hold as a precaution per the pharmaceutical company.
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Pediatric Epilepsy Research Foundation, West Therapuetics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
This is a prospective randomized trial comparing 3 treatment arms: Cosyntropin Injectable Suspension, 1 mg/mL Vigabatrin Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures. The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Spasm
Keywords
Vigabatrin, Cosyntropin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Blinded outcome measure
Allocation
Randomized
Enrollment
394 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
Arm Type
Experimental
Arm Title
Cosyntropin Injectable Suspension, 1 mg/mL
Arm Type
Experimental
Arm Title
Vigabatrin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cosyntropin Injectable Suspension, 1 mg/mL
Intervention Description
Injectable
Intervention Type
Drug
Intervention Name(s)
Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Intervention Description
Injectable + oral solution
Intervention Type
Drug
Intervention Name(s)
Vigabatrin
Intervention Description
oral
Primary Outcome Measure Information:
Title
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
Description
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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)
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.
Time Frame
Day 14-42
Title
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
Description
Difference in proportion of subjects who are seizure free between 5 and 6 months after treatment.
Time Frame
6 months
Title
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
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.
Time Frame
18 months chronological age
Title
Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
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.
Time Frame
18 months chronological age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly G. Knupp, MD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Healthcare of Atlanta at Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Novel Approach to Infantile Spasms

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