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A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

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ClinicalTrials.gov Identifier: NCT03976076
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bio-Pharm Solutions Co., Ltd.

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

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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


Arm Intervention/treatment
Experimental: JBPOS0101 (investigational product) Drug: JBPOS0101
JBPOS0101 (investigational product)




Primary Outcome Measures :
  1. Incidence and severity of treatment emergent adverse events observed by the investigator at each visit or reported to the investigator [ Time Frame: 77 days ]


Information from the National Library of Medicine

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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
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Contact: Brandon Choi 973-224-0567 bchoi@b-psol.com
Contact: Scott Wood 720-504-9454 scott.wood@iconplc.com

Locations
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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
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Study Director: Brandon Choi Sponsor Management
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spasm
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes