A Novel Approach to Infantile Spasms

University of Colorado Denver (CU Denver)

Status and phase: Suspended; Phase 3

Conditions: Infantile Spasm

Treatments: Drug: Cosyntropin Injectable Suspension, 1 mg/mL; Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin; Drug: Vigabatrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03347526

17-0222

Details and patient eligibility

About

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).

Full 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.

Enrollment: 394 estimated patients

Sex: All

Ages: 2 months to 2 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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394 participants in 3 patient groups

Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin

Experimental group

Treatment:

Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin

Cosyntropin Injectable Suspension, 1 mg/mL

Experimental group

Treatment:

Drug: Cosyntropin Injectable Suspension, 1 mg/mL

Vigabatrin

Active Comparator group

Treatment:

Drug: Vigabatrin