Clinical trial NCT03347526: 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
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Infantile Spasm
Keywords: Vigabatrin
Cosyntropin
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Pediatric Epilepsy Research Foundation
name: West Therapuetics, Inc
First posted: 2017-11-20
Enrollment: 394
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
timeFrame: 2 weeks
Secondary outcomes:
measure: 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)
timeFrame: Day 14-42
measure: A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.
timeFrame: 6 months
measure: Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
timeFrame: 18 months chronological age
measure: Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).
timeFrame: 18 months chronological age
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Scottish Rite
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Kelly G. Knupp, MD
role: PRINCIPAL_INVESTIGATOR
References: