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Trial record 5 of 27 for:    "X-linked infantile spasm syndrome"

A Novel Approach to Infantile Spasms

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ClinicalTrials.gov Identifier: NCT03347526
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Pediatric Epilepsy Research Foundation
West Therapuetics, Inc
Information provided by (Responsible Party):
University of Colorado, Denver

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).

Condition or disease Intervention/treatment Phase
Infantile Spasm Drug: Cosyntropin Injectable Suspension, 1 mg/mL Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin Drug: Vigabatrin Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Blinded outcome measure
Primary Purpose: Treatment
Official Title: A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Injectable + oral solution

Experimental: Cosyntropin Injectable Suspension, 1 mg/mL Drug: Cosyntropin Injectable Suspension, 1 mg/mL
Injectable

Active Comparator: Vigabatrin Drug: Vigabatrin
oral




Primary Outcome Measures :
  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 ]
    a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.


Secondary Outcome Measures :
  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 ]
    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 ]
    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 ]
    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 ]
    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.



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Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347526


Contacts
Contact: Allison Applegate 720-777-9321 allison.applegate@childrenscolorado.org

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Knupp       kelly.knupp@childrenscolorado.org   
Contact: Allison Applegate       allison.applegate@childrencolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Pediatric Epilepsy Research Foundation
West Therapuetics, Inc
Investigators
Principal Investigator: Kelly G. Knupp, MD University of Colorado - Anschutz Medical Campus

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03347526     History of Changes
Other Study ID Numbers: 17-0222
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Vigabatrin
Cosyntropin

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
Vigabatrin
Cosyntropin
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists