SuspendedPhase 3

A Novel Approach to Infantile Spasms

Stopped: Study on enrollment hold as a precaution per the pharmaceutical company.

United States394 participantsStarted 2018-04-19

Plain-language 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).

Who can participate

Age range2 Months – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT03347526

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Infantile Spasm trials