A Novel Approach to Infantile Spasms

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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03347526

Enrollment

394

Registered

2017-11-20

Start date

2018-04-19

Completion date

2021-08-31

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Spasm

Keywords

Vigabatrin, Cosyntropin

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.

Interventions

DRUGCosyntropin Injectable Suspension, 1 mg/mL

Injectable

DRUGCosyntropin Injectable Suspension 1 MG/ML + vigabatrin

Injectable + oral solution

DRUGVigabatrin

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Blinded outcome measure

Eligibility

Sex/Gender

ALL

Age

2 Months to 2 Years

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

Design outcomes

Primary

Measure	Time frame	Description
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).	2 weeks	a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.

Secondary

Measure	Time frame	Description
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)	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.
A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.	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).	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026