A Novel Approach to Infantile Spasms

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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

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:

        1. Cosyntropin Injectable Suspension, 1 mg/mL

        2. Vigabatrin

        3. 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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)

Condition

Infantile Spasm

Intervention

Cosyntropin Injectable Suspension, 1 mg/mL

Study Arms / Comparison Groups

 Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

394

Start Date

April 19, 2018

Completion Date

August 2021

Primary Completion Date

June 2021

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
      

Gender

All

Ages

2 Months - 2 Years

Accepts Healthy Volunteers

No

Contacts

Kelly G. Knupp, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03347526

Organization ID

17-0222


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 Pediatric Epilepsy Research Foundation

Study Sponsor

Kelly G. Knupp, MD, Principal Investigator, University of Colorado - Anschutz Medical Campus


Verification Date

May 2021