A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
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| ClinicalTrials.gov Identifier: NCT03976076 |
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Recruitment Status :
Recruiting
First Posted : June 5, 2019
Last Update Posted : March 5, 2021
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Sponsor:
Bio-Pharm Solutions Co., Ltd.
Information provided by (Responsible Party):
Bio-Pharm Solutions Co., Ltd.
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Brief Summary:
This open label, multicenter study allows JBPOS0101 (investigational product) to be given as either add-on therapy or monotherapy for patients with refractory infantile spasms. The design and choice of study population of this Phase 2 clinical study is based on the need to provide initial safety, tolerability, pharmacokinetics (PK), and efficacy outcomes of the investigational product for future clinical studies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Refractory Infantile Spasms | Drug: JBPOS0101 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 35 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Patients will receive the investigational product at a dose of 6 mg/kg orally twice daily; 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 the day of Visit 3, the dose will be escalated and patients will receive the investigational product at a dose of 9 mg/kg orally twice daily. Starting on Day 15, the dose will be escalated again and patients will receive the investigational product at a dose of 15 mg/kg orally twice daily until the end of Treatment Period 1. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | November 30, 2021 |
| Estimated Study Completion Date : | March 7, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Developmental and epileptic encephalopathy 1
MedlinePlus related topics:
Muscle Cramps
| Arm | Intervention/treatment |
|---|---|
| Experimental: JBPOS0101 (investigational product) |
Drug: JBPOS0101
JBPOS0101 (investigational product) |
Primary Outcome Measures :
- Incidence and severity of treatment emergent adverse events observed by the investigator at each visit or reported to the investigator [ Time Frame: 77 days ]
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| Ages Eligible for Study: | 6 Months to 36 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female between 6 months through 36 months of age at the time of informed consent
- Has clinical diagnosis of 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 has no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or has no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and is contraindicated to and/or refused by the patient's legal representative(s) for treatment with one or both other 2 therapies.
- Patient has general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on physical and neurological examinations, medical history, normal renal function and electrocardiogram (ECG), and clinical laboratory values completed during the Screening Period visit (Visit 1).
Exclusion Criteria:
- Patient considered by the investigator, for any reason (including, but not limited to, the risks described as precautions and warnings in the current version of the investigator's brochure for investigational product) to be an unsuitable candidate to receive the investigational product.
- Patient has known or suspected allergy to the investigational product or apple juice.
- Patient has clinically significant renal impairment, defined as creatinine >1.5 mg/dL or blood urea nitrogen >2 × upper limit of normal (ULN); clinically significant liver dysfunction, defined as total bilirubin ≥2 × ULN, or aspartate aminotransferase or alanine aminotransferase ≥3 × ULN; has clinically significant abnormal laboratory values; the investigator may deem the patient eligible if he/she judges the laboratory values to be not clinically significant.
- Patient has an ongoing or known history of human immunodeficiency virus infection, or chronic hepatitis B or C.
- Patient has a clinically significant abnormality on ECG that, in the opinion of the investigator, increases the safety risks of participating in the study.
- Patient has a neurodegenerative disorder as the underlying cause of IS.
- Patient has a known history of aspiration pneumonia within the past year.
- Patient has previously participated in another clinical study of the investigational product or received any investigational drug or device or investigational therapy within 30 days of study entry.
- Patient has received therapy with felbamate, cannabinoids, ketogenic diet or vagus nerve stimulation within 14 days of screening.
- Patient has received therapy with a medication known to be a CYP3A4 substrate and whose PK has been shown to be impacted in the presence of a CYP3A4 inhibitor within 14 days of screening.
- Patient has not remained at stables doses of all drugs used for treating epileptic seizures for at least 14 days prior to screening (except for rescue medications used for acute treatment of breakthrough seizures which are not known to be CYP3A4 substrates and whose PK has not been shown to be impacted in the presence of a CYP3A4 inhibitor.
- Patient has a lethal or potentially lethal condition other than infantile spasms, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia.
- Patient has a body weight below 5 kg.
- Patient has an underlying metabolic disease associated with glucose intolerance (e.g., glucose transporter deficiencies).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976076
Contacts
| Contact: Brandon Choi | 973-224-0567 | bchoi@b-psol.com | |
| Contact: Scott Wood | 720-504-9454 | scott.wood@iconplc.com |
Locations
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Kathy Hummel 501-364-2715 hummelkathy@uams.edu | |
| Principal Investigator: Freedom Perkins, MD | |
| United States, California | |
| Children's Hospital LA | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Martha Arellano-Garcia margarcia@chla.usc.edu | |
| Principal Investigator: Wendy Mitchell, MD | |
| UCLA - David Geffen School of Medicine | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Ruby Escalante 310-206-5586 rubyescalante@mednet.ucla.edu | |
| Principal Investigator: Shaun Hussain, MD | |
| UCSF Epilepsy Center | Recruiting |
| San Francisco, California, United States, 94158-2549 | |
| Contact: Antoinette Swanson 415-502-1921 Antoinette.Swanson@ucsf.edu | |
| Principal Investigator: Joseph Sullivan, MD | |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Galen Resler 720-777-0738 Galen.resler@childrenscolorado.org | |
| Principal Investigator: Charuta Joshi, MD | |
| United States, Florida | |
| Pediatric Neurology, PA | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| Contact: Kathy Carr 407-293-1122 ext 221 kcarr@pediatricneurologypa.com | |
| Principal Investigator: Ronald Davis, MD | |
| United States, Kentucky | |
| University of Louisville School of Medicine | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Pediatric Research Unit 502-629-5820 ext 2 kcpcru@louisville.edu | |
| Principal Investigator: Vinay Puri, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Bridget Neja 507-266-9150 Neja.Bridget@mayo.edu | |
| Principal Investigator: Katherine Nickels, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Karen Cornett 919-684-1143 k.cornett@duke.edu | |
| Principal Investigator: Muhammad Zafar, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Honglian Huang 216-445-2366 | |
| Contact: Xiaoming Zhang 216-445-7510 | |
| Principal Investigator: Deepak Lachhwani, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Beata Dyar 503-494-8216 dyar@ohsu.edu | |
| Principal Investigator: Robert Jason Coryell, MD | |
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia (CHOP) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Emily Chambers 215-590-1719 ChambersEM@email.chop.edu | |
| Principal Investigator: Eric Marsh, MD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Francis Oyih 832-826-5961 fxoyih@texaschildrens.org | |
| Principal Investigator: Krystal Sully, MD | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Kathryn O'Hara 804-828-3862 kathryn.ohara@vcuhealth.org | |
| Principal Investigator: Lawrence Morton, MD | |
| United States, Washington | |
| Multicare Institute for Research and Innovation | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Amber Hecker-Johnson 253-403-9350 aheckerjohnson@multicare.org | |
| Principal Investigator: Steven Phillips, MD | |
Sponsors and Collaborators
Bio-Pharm Solutions Co., Ltd.
Investigators
| Study Director: | Brandon Choi | Sponsor Management |
| Responsible Party: | Bio-Pharm Solutions Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT03976076 |
| Other Study ID Numbers: |
CL-0101-WS01 |
| First Posted: | June 5, 2019 Key Record Dates |
| Last Update Posted: | March 5, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Spasm Spasms, Infantile Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases Epileptic Syndromes |