A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bio-Pharm Solutions Co., Ltd.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.

Research Team

Hee Jin Kim

Principal Investigator

Bio-Pharm Solutions

Eligibility Criteria

Inclusion Criteria

Male or female between 6 months through 36 months of age at the time of informed consent

Had clinical diagnosis of Infantile spasms (IS), confirmed by video-electroencephalogram (EEG) analysis, and hypsarrhythmia on EEG at screening according to the Burden of Amplitudes and Epileptiform Discharges (BASED) scale score.

As assessed by the investigator had no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or had no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and was contraindicated to and/or refused by the patient's legal representative(s) for treatment with one or both other 2 therapies.

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Treatment Details

Interventions

JBPOS0101 (Other)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: JBPOS0101 (investigational product)Experimental Treatment1 Intervention

During Treatment Period 1, the IP was administered at 6 mg/kg, per oral (PO), twice a day (BID), once in the morning and 12 hours following the morning dose during the first 7 days of Treatment Period 1. Starting from the PM dose on Visit 3, the dose was escalated and patients received the Investigational Product (JBPOS0101) (IP) at a dose of 9 mg/kg orally BID. Starting on Day 15, the dose was escalated again and patients received the IP at a dose of 15 mg/kg orally BID until the end of Treatment Period 1 (Day 28). Each dose of the IP was administered after at least a 2-hour fast. Food was given 2 hours after dosing.