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A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

NCT03976076 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-22

Study results available
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Summary

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

Conditions

  • Refractory Infantile Spasms

Interventions

DRUG

JBPOS0101

JBPOS0101 (investigational product)

Sponsors & Collaborators

  • Bio-Pharm Solutions Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hee Jin Kim · Bio-Pharm Solutions

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2021-12-10
Completion
2021-12-10
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976076 on ClinicalTrials.gov