A Novel Approach to Infantile Spasms

Infantile Spasm Clinical Trial

Official title:

A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03347526
• Other study ID #: 17-0222
• Status: Suspended
• Phase: Phase 3
• Start date: April 19, 2018
• Est. completion date: August 2021

Study information

• Verified date: May 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 394
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Infantile Spasm
• Spasm
• Spasms, Infantile

Intervention

Drug:
• Cosyntropin Injectable Suspension, 1 mg/mL
Injectable
• Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin
Injectable + oral solution
• Vigabatrin
oral

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta at Scottish Rite	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Atrium Health	Charlotte	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSF Medical Center	San Francisco	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Pediatric Epilepsy Research Foundation, West Therapuetics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	Day 14-42
Secondary	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.	6 months
Secondary	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.	18 months chronological age
Secondary	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.	18 months chronological age