A Novel Approach to Infantile Spasms

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT03347526
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: A Novel Approach to Infantile Spasms
• Scientific title: A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
• Date of first enrolment: April 19, 2018
• Target sample size: 394
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT03347526
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Kelly G. Knupp, MD
• Affiliation: University of Colorado - Anschutz Medical Campus

Key inclusion & exclusion 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



Age minimum: 2 Months
Age maximum: 2 Years
Gender: All

Health Condition(s) or Problem(s) studied

Infantile Spasm

Intervention(s)

Drug: Cosyntropin Injectable Suspension, 1 mg/mL

Drug: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin

Drug: Vigabatrin

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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 the proportion of subjects who become seizure free at 6 months. [Time Frame: 6 months]

Secondary ID(s)

17-0222

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

West Therapuetics, Inc

Pediatric Epilepsy Research Foundation