Trial · NCT03976076
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
NCT03976076, Phase 2, Terminated, Bio-Pharm Solutions Co., Ltd.; results first posted 2023-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients. Trials, record NCT03976076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03976076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
- NCT number
- NCT03976076
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Bio-Pharm Solutions Co., Ltd.
- Conditions
- Refractory Infantile Spasms
- Interventions
- JBPOS0101
- First posted
- 2019-06-05
- Last updated
- 2024-08-22
- Results first posted
- 2023-02-16
- Limitations and caveats
- No limitations reported for the study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 to Day 56 | TEAEs were defined as any event that did not present before exposure to the investigational product (IP) or any event already present that worsened in either intensity or frequency after exposure to the IP. |
| Secondary | JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 1 | 0.5 to1.5 hours post morning (AM) dose on Day 1 | Pharmacokinetics: JBPOS0101 plasma concentration 0.5 - 1.5 hours post morning dose on Day 1 |
| Secondary | JBPOS0101 Plasma Concentration 4-6 Hours Post Morning Dose, Day 1 | 4 to 6 hours post morning (AM) dose on Day 1 | Pharmacokinetics: JBPOS0101 plasma concentration 4 - 6 hours post morning dose on Day 1 |
| Secondary | JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 1 | 8 hours post morning (AM) dose and pre-PM dose on Day 1 | Pharmacokinetics: JBPOS0101 plasma concentration 8 hours post morning dose and pre-PM dose on Day 1. |
| Secondary | JBPOS0101 Plasma Concentration 0.5 -1.5 Hours Post Morning Dose, Day 21 | 0.5 to1.5 hours post morning (AM) dose on Day 21 | Pharmacokinetics: JBPOS0101 plasma concentration 0.5 - 1.5 hours post morning dose on Day 21 |
| Secondary | JBPOS0101 Plasma Concentration 4 - 6 Hours Post Morning Dose, Day 21 | 4 to 6 hours post morning (AM) dose on Day 21 | Pharmacokinetics: JBPOS0101 plasma concentration 4 - 6 hours post morning dose on Day 21 |
| Secondary | JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 21 | 8 hours post morning (AM) dose and pre-PM dose on Day 21 | Pharmacokinetics: JBPOS0101 plasma concentration 8 hours post morning dose and pre-PM dose on Day 21. |
| Secondary | JBPOS0101 Urine Concentration at Day 1 | Day 1 | Pharmacokinetics: JBPOS0101 urine concentration on Day 1. Urine samples were collected following the morning dose. |
| Secondary | JBPOS0101 Urine Concentrations at Day 21 | Day 21 | Pharmacokinetics: JBPOS0101 urine concentration on Day 21. Urine samples were collected following the morning dose. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 to Day 56 | Safety Population: Included all patients who were treated with at least one dose of the IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 1 | 0.5 to1.5 hours post morning (AM) dose on Day 1 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. | Nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | JBPOS0101 Plasma Concentration 4-6 Hours Post Morning Dose, Day 1 | 4 to 6 hours post morning (AM) dose on Day 1 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 1 | 8 hours post morning (AM) dose and pre-PM dose on Day 1 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 11 signifies number of participants with available data for specified time. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Plasma Concentration 0.5 -1.5 Hours Post Morning Dose, Day 21 | 0.5 to1.5 hours post morning (AM) dose on Day 21 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 11 signifies number of participants with available data for specified time. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Plasma Concentration 4 - 6 Hours Post Morning Dose, Day 21 | 4 to 6 hours post morning (AM) dose on Day 21 | PK population: PK Population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration.~Here N=12 is the overall number of participants. n= 10 signifies number of participants with available data for specified time. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 21 | 8 hours post morning (AM) dose and pre-PM dose on Day 21 | PK population: PK Population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration.~Here N=12 is the overall number of participants. n= 9 signifies number of participants with available data for specified time. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Urine Concentration at Day 1 | Day 1 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 10 signifies number of participants with available data for specified time. | ng/mL | MEAN |
| SECONDARY | JBPOS0101 Urine Concentrations at Day 21 | Day 21 | PK population: The PK population included all patients, without any major protocol deviation affecting the secondary endpoint analysis, who were treated with at least one dose of the IP and had at least one measurable PK concentration. Here N=12 is the overall number of participants. n= 9 signifies number of participants with available data for specified time. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | JBPOS0101 (Investigational Product) | 12 | Participants | ||
| JBPOS0101 Plasma Concentration 0.5 - 1.5 Hours Post Morning Dose, Day 1 | JBPOS0101 (Investigational Product) | 6150.0 | Standard Deviation 1845.45 | Nanograms per milliliter (ng/mL) | |
| JBPOS0101 Plasma Concentration 4-6 Hours Post Morning Dose, Day 1 | JBPOS0101 (Investigational Product) | 5854.2 | Standard Deviation 904.85 | ng/mL | |
| JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 1 | JBPOS0101 (Investigational Product) | 4172.7 | Standard Deviation 765.13 | ng/mL | |
| JBPOS0101 Plasma Concentration 0.5 -1.5 Hours Post Morning Dose, Day 21 | JBPOS0101 (Investigational Product) | 22945.5 | Standard Deviation 3599.27 | ng/mL | |
| JBPOS0101 Plasma Concentration 4 - 6 Hours Post Morning Dose, Day 21 | JBPOS0101 (Investigational Product) | 18070.0 | Standard Deviation 4184.11 | ng/mL | |
| JBPOS0101 Plasma Concentration 8 Hours Post Morning Dose and Pre-PM Dose, Day 21 | JBPOS0101 (Investigational Product) | 12921.1 | Standard Deviation 3220.22 | ng/mL | |
| JBPOS0101 Urine Concentration at Day 1 | JBPOS0101 (Investigational Product) | 3410.0 | Standard Deviation 1152.50 | ng/mL | |
| JBPOS0101 Urine Concentrations at Day 21 | JBPOS0101 (Investigational Product) | 14360.0 | Standard Deviation 6986.77 | ng/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | JBPOS0101 (Investigational Product) | 12 | |
| Overall Study | COMPLETED | JBPOS0101 (Investigational Product) | 10 | |
| Overall Study | NOT COMPLETED | JBPOS0101 (Investigational Product) | 2 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | JBPOS0101 (Investigational Product) | 3 | 12 | 3 |
| other | Sedation | Nervous system disorders | JBPOS0101 (Investigational Product) | 2 | 12 | 4 |
| other | Liver function test increased | Investigations | JBPOS0101 (Investigational Product) | 2 | 12 | 2 |
| other | Electrocardiogram QT prolonged | Investigations | JBPOS0101 (Investigational Product) | 1 | 12 | 1 |
| other | Gamma-glutamyltransferase increased | Investigations | JBPOS0101 (Investigational Product) | 1 | 12 | 2 |
| other | Abnormal behaviour | Psychiatric disorders | JBPOS0101 (Investigational Product) | 1 | 12 | 1 |
| other | Irritability | Psychiatric disorders | JBPOS0101 (Investigational Product) | 2 | 12 | 2 |
| other | Constipation | Gastrointestinal disorders | JBPOS0101 (Investigational Product) | 1 | 12 | 1 |
| other | Fatigue | General disorders | JBPOS0101 (Investigational Product) | 1 | 12 | 1 |
| other | Sedation complication | Injury, poisoning and procedural complications | JBPOS0101 (Investigational Product) | 1 | 12 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JBPOS0101 (Investigational Product) | 0 | 12 |
| Total, other adverse events | JBPOS0101 (Investigational Product) | 12 | 12 |
| Total, serious adverse events | JBPOS0101 (Investigational Product) | 3 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03976076
GET https://conductscience.org/api/trials/v1/NCT03976076/events?page=2