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JBPOS0101 for Infantile Spasms

Phase 2
Waitlist Available
Research Sponsored by Bio-Pharm Solutions Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 6 hours post morning (am) dose on day 21
Awards & highlights

Study Summary

This study is evaluating whether a medication may help treat infantile spasms.

Eligible Conditions
  • Infantile Spasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 6 hours post morning (am) dose on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 6 hours post morning (am) dose on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 1
JBPOS0101 Plasma Concentration 0.5 -1.5 Hours Post Morning Dose, Day 21
JBPOS0101 Plasma Concentration 4 - 6 Hours Post Morning Dose, Day 21
+5 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Bio-Pharm Solutions Co., Ltd.Lead Sponsor
Brandon ChoiStudy DirectorSponsor Management

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
2020. "A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03976076.
~3 spots leftby Apr 2025
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