Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Study Overview

• Status: Recruiting
• Conditions: Seizures; Lennox Gastaut Syndrome
• Intervention / Treatment: Drug: Carisbamate

Detailed Description

The secondary objectives are:

• To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS)
• Evaluate the safety, tolerability of carisbamate in the LGS population
• Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Barbara Remes; Phone Number: 201-421-3810; Email: bremes@sklsi.com

Study Locations

• Argentina
  • Mendoza, Argentina
    • Completed
    • Resolution Psychopharmacology Research Institute
  • Cordoba
    • Córdoba, Cordoba, Argentina
      • Completed
      • Hospital de Ninos de La Santisma Trinidad
• Australia
  • Heidelberg, Australia
    • Recruiting
    • Austin Hosptial
    • Principal Investigator: Ingrid Scheffer, MD
  • Melbourne, Australia
    • Recruiting
    • Alfred Health
    • Principal Investigator: Patrick Kwan
  • Nedlands, Australia
    • Completed
    • Perth's Children Hospital
  • South Brisbane, Australia
    • Completed
    • Queensland Children's Hospital
• Colombia
  • Barranquilla, Colombia
    • Withdrawn
    • Fundación Hospital Universidad del Norte
  • Cali, Colombia
    • Withdrawn
    • Fundacion Valle del Lili/Clinic - Outpatient
  • Envigado, Colombia
    • Completed
    • CliniSalud del Sur S.A.S - Centro de Investigación
  • Medellín, Colombia
    • Recruiting
    • Institutio Neurologico de Colombia
    • Principal Investigator: Maria Jiminez, MD
  • Medellín, Colombia
    • Completed
    • Hospital Pabloe Tubon Uribe
• Germany
  • Bayern
    • Erlangen, Bayern, Germany
      • Recruiting
      • Universitatsklinikum Erangen
      • Principal Investigator: Hajo Martinus Hamer, MD
  • Sachsen
    • Radeberg, Sachsen, Germany
      • Recruiting
      • Kleinwachau Sächsisches Epilepsiezentrum
      • Principal Investigator: Nils Holert, MD
• Greece
  • Attiki
    • Maroúsi, Attiki, Greece
      • Recruiting
      • IASO Children's Hospital
      • Principal Investigator: Antigoni Papavasileiou, MD
• Hungary
  • Budapest, Hungary
    • Completed
    • Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet
  • Budapest, Hungary
    • Recruiting
    • Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
    • Contact: Anna Sakovics, MD
• Israel
  • Be'er Sheva, Israel
    • Completed
    • Soroka University Medical Centre
  • Jerusalem, Israel, 91220
    • Completed
    • Hadassah Medical Center
  • Ramat Gan, Israel
    • Completed
    • Sheba Medical Center
  • Tel Aviv
    • Tel Aviv Yafo, Tel Aviv, Israel
      • Completed
      • Tela Viv Sourlasky Medical Center
• Italy
  • Firenze, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
    • Principal Investigator: Renzo Guerrini, MD
  • Milano, Italy
    • Completed
    • ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo
  • Verona, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata di Verona
    • Principal Investigator: Francesca Darra, MD
  • Liguria
    • Genova, Liguria, Italy
      • Recruiting
      • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
      • Principal Investigator: Pasquale Striano, MD
  • Lombardia
    • Milano, Lombardia, Italy
      • Recruiting
      • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
      • Principal Investigator: Monica Lodi, MD
    • Milano, Lombardia, Italy
      • Recruiting
      • Fondazione IRCCS Di Rilievo Nazionale Instituto
      • Principal Investigator: Elena Freri, MD
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Chilgok Hospital
    • Principal Investigator: Soonhak Kwon, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Byung Chan Lim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Jee Hun S. Lee, MD
• Mexico
  • Culiacán, Mexico
    • Recruiting
    • Neurociencias Estudios Clinicos S.C.
    • Principal Investigator: Elmer Lopez Meza, MD
  • Mexico City, Mexico, 06700
    • Recruiting
    • Clinstile, S.A. de C.V.
    • Principal Investigator: Sandra Quinones, MD
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Recruiting
      • Hospital Civil Fray Antonio Alcalde
      • Principal Investigator: Hugo Ceja Moreno, MD
• Poland
  • Kraków, Poland
    • Recruiting
    • Centrum Medyczne Plejady
    • Principal Investigator: Marta Zolnowska, MD
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland
      • Completed
      • Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Centro Hospitalar de Lisboa Norte, EPE
    • Principal Investigator: Sofia Quintas, MD
  • Lisboa, Portugal
    • Completed
    • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital São Francisco Xavier
  • Porto, Portugal
    • Recruiting
    • Centro Hospitalar de Sao Joao, EPE
    • Principal Investigator: Raquel Sousa, MD
  • Setubal
    • Almada, Setubal, Portugal
      • Completed
      • Hospital Garcia de Orta
• Serbia
  • Belgrade, Serbia
    • Recruiting
    • Childrens University Hospital
    • Principal Investigator: Dimitrije Nikolic, MD
  • Belgrade, Serbia
    • Recruiting
    • University Clinical Center of Serbia - PPDS
    • Principal Investigator: Dragoslav Sokic, MD
  • Kragujevac, Serbia
    • Recruiting
    • University Clinical Center Kragujevac
    • Principal Investigator: Aleksandar Gavrilovic, MD
  • Niš, Serbia
    • Recruiting
    • University Clinical Center Nis
    • Principal Investigator: Tatjana Tosic, MD
  • Novi Sad, Serbia
    • Recruiting
    • Children and Youth Health Care Institute of Vojvodina
    • Principal Investigator: Marija Knezevic-Pogancev, MD
    • Contact: Tatjana Redzek Mudrinic, MD
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Infantil Universitario Niño Jesus - PIN
    • Principal Investigator: Victor Soto Insuga, MD
  • Madrid, Spain
    • Recruiting
    • Hospital Ruber Internacional (Grupo Quironsalud)
    • Principal Investigator: Antonio Gil-Nigel, MD
  • Barcelona
    • Esplugues De Llobregat, Barcelona, Spain
      • Completed
      • Hospital Sant Joan de Deu - PIN
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Principal Investigator: Ting-Rong Hsu, MD
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Principal Investigator: Wang-Tso Lee, MD
  • Taoyuan, Taiwan
    • Completed
    • Chang Gung Memorial Hospital
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University Hospital
      • Principal Investigator: Brenda Porter, MD
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Completed
      • University of Florida Health Science Center
    • Orlando, Florida, United States, 32803
      • Completed
      • Adventhealth
    • Tampa, Florida, United States, 33609
      • Recruiting
      • Pediatric Epilepsy and Neurology Specialists
      • Principal Investigator: Jose Ferreira, MD
    • Tampa, Florida, United States, 33620
      • Completed
      • University of South Florida
    • Wellington, Florida, United States, 33414
      • Completed
      • Axcess Medical Research
  • Idaho
    • Boise, Idaho, United States, 83702
      • Completed
      • Consultants In Epilepsy and Neurology PLLC
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Completed
      • Bluegrass Epilepsy Research, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Completed
      • University Medical Center New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Principal Investigator: Joon Yi Kang, MD
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Mid-Atlantic Epilepsy and Sleep Center
      • Contact: Arkady Barber
      • Principal Investigator: Pavel Klein, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Completed
      • Mayo Clinic
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Completed
      • University of Missouri School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Northeast Regional Epilepsy Group
      • Principal Investigator: Eric Segal, MD
    • New Brunswick, New Jersey, United States, 08901
      • Completed
      • St. Peters Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Completed
      • Montefiore
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Recruiting
      • Duke University Clinical Research at Pickett Road
      • Principal Investigator: Muhammad Zafar, MD
    • Winston-Salem, North Carolina, United States, 27101
      • Completed
      • Wake Forest University - School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Principal Investigator: Eric Marsh, MD
  • Texas
    • Austin, Texas, United States, 78758
      • Completed
      • Austin Epilepsy Care Center - Clinic/Outpatient Facility
    • Dallas, Texas, United States, 75231
      • Completed
      • Neurology Consultants of Dallas, PA - Hospital
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Completed
      • Virginia Epilepsy and Neurodevelopmental Clinic at WNC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject must have a documented history of Lennox-Gastaut syndrome by:

   1. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
   2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz)
   3. History of developmental delay
2. Male or female subjects
3. Subjects must be age 4-55 years at the time of consent/assent
4. Must have been <11 years old at the onset of LGS
5. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).
6. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
7. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
8. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
9. Parents or caregivers must be able to keep accurate seizure diaries
10. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.
11. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study
12. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
13. History of COVID-19 vaccination is permitted

Exclusion Criteria:

1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
5. Current use of felbamate with less than 18 months of continuous exposure
6. Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.
7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
8. Status epilepticus within 12 weeks prior to Visit 1
9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
10. Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)
11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization
12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated <5 months year prior to enrollment. Stimulation parameters that have been stable for <4 weeks, or Battery life of unit not anticipated to extend for duration of trial.
13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant
14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated
15. Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
16. Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are <3 x ULN
17. Subject with total bilirubin [TBL] >2 x ULN (except for Gilbert's syndrome).
18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)
20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
22. Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)
23. Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin
24. Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome
25. Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG)
26. Benzodiazepine rescue administered on average more than once a week in the month before Visit 1
27. Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carisbamate 200 mg BID arm; Age: 4 to <12y* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID	Drug: Carisbamate; Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]). Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Experimental: Carisbamate 300 mg BID arm; Age: 4 to <12y* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID	Drug: Carisbamate; Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]). Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Placebo Comparator: Placebo matched to 200 mg BID arm; Age: 4 to <12y* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID	Drug: Carisbamate; Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]). Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Placebo Comparator: Placebo matched to 300 mg BID arm; Age: 4 to <12y* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID	Drug: Carisbamate; Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]). Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.	Efficacy of Carisbamate YKP509- Scoring will be from 1 to 7 with 1 (very much improved) to 7 (very much worse)	3 years
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the maintenance phase of the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the maintenance phase of the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years
Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years
Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the double-blind treatment period.	Efficacy of Carisbamate YKP509	3 years

Collaborators and Investigators

• Sponsor: SK Life Science, Inc.
• Investigators: Study Director: Marc Kamin, MD, SK Life Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Adults; Pediatrics; Seizures; Lennox Gastaut Syndrome
• Additional Relevant MeSH Terms: Epileptic Syndromes; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Genetic Diseases, Inborn; Disease; Epilepsy; Syndrome; Seizures; Lennox Gastaut Syndrome
• Other Study ID Numbers: YKP509C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No