A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures (X-ACKT)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).

Study Overview

• Status: Recruiting
• Conditions: Primary Generalized Tonic-Clonic Seizures
• Intervention / Treatment: Drug: Placebo; Drug: XEN1101

Detailed Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in subjects diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 anti-seizure medications (ASMs). Eligible subjects will be randomly assigned 1:1 to XEN1101 or placebo: subjects aged ≥ 18 years will receive XEN1101 25 mg or placebo, and subjects aged ≥12 years and <18 years will receive either XEN1101 15 mg, 25 mg, or placebo. Randomization will be stratified based on region, age group, and background use of CYP3A4-inducer ASMs. Eligible subjects will have up to 9.5 weeks durations to assess the baseline frequency of seizures, followed by a double-blind treatment period (DBP) where subjects will receive 12 weeks of blinded treatment. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.

Subjects who complete the 12-week DBP will have the opportunity to enroll in a separate open-label-extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter an 8-week post-treatment follow-up period.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xenon Medical Affairs; Phone Number: 1-604-484-3300; Email: XenonCares@xenon-pharma.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Active, not recruiting
    • Hospital Italiano
  • Buenos Aires, Argentina, C1023AAB
    • Recruiting
    • Stat Research S.A.
  • Buenos Aires, Argentina, 1221
    • Active, not recruiting
    • Hospital General de Agudos J.M. Ramos Mejia
  • San Miguel de Tucumán, Argentina, 4000
    • Active, not recruiting
    • Sanatorio del Sur S.A
• Australia
  • Parkville, Australia, 3050
    • Recruiting
    • The Royal Melbourne Hospital
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Withdrawn
      • Southern Neurology
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Mater Misericordiae Ltd
  • VC
    • Melbourne, VC, Australia, 3004
      • Recruiting
      • The Alfred Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health Pharmacy Clinical Trials
    • Melbourne, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital Melbourne, Clinical Neurosciences
• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • University Hospital Innsbruck
  • Linz, Austria, 4021
    • Recruiting
    • Universitaetsklinik fuer Kinder
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitätsklinik für Neurologie
  • Vienna, Austria, 1090
    • Recruiting
    • Universitätsklinik für Neurologie, Medizinische Universität Wien
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques universitaires Saint-Luc
  • Ghent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Recruiting
    • Multiprofile Hospital for Active Treatment Puls AD
  • Sofia, Bulgaria, 1142
    • Withdrawn
    • First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel
  • Sofia, Bulgaria, 1113
    • Recruiting
    • MHATNP 'Sveti Naum' EAD
• Canada
  • Alberta
    • Lethbridge, Alberta, Canada, T1J 0N9
      • Recruiting
      • Center for Neurologic Research
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Recruiting
      • Children and Women's Health Centre of BC (BC Children's Hospital)
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Recruiting
      • London Health Sciences Center
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Le Centre Hospitalier de l'Universite' de Montreal (CHUM)
• Chile
  • Santiago, Chile
    • Active, not recruiting
    • Centro de Investigacion Clinica UC-CICUC
• Croatia
  • Osijek, Croatia, 310 00
    • Withdrawn
    • Clinical Hospital Center Osijek
  • Rijeka, Croatia, 510 00
    • Withdrawn
    • Clinical Hospital Center Rijeka
  • Zagreb, Croatia, 100 00
    • Withdrawn
    • University Hospital Center Zagreb
• Czechia
  • Prague, Czechia, 150 06
    • Withdrawn
    • Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol
• France
  • Lille, France, 59037
    • Recruiting
    • CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique
  • Lyon, France, 9003
    • Recruiting
    • Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
  • Rennes, France, 35033
    • Recruiting
    • CHU de Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67098
    • Recruiting
    • CHU de Strasbourg - Hôpital de Hautepierre
• Germany
  • Aachen, Germany, D-52074
    • Recruiting
    • Universitätsklinikum Aachen
  • Berlin, Germany, 13509
    • Withdrawn
    • Vivantes Humboldt Klinikum
  • Bielefeld, Germany, 33617
    • Recruiting
    • Bethel Epilepsy Centre
  • Frankfurt, Germany, 60528
    • Recruiting
    • Universitätsklinikum Frankfurt
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Epilepsiezentrum im Neuozentrum
  • Marburg, Germany, 35043
    • Recruiting
    • Philipps-Universität Marburg
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Universität München
  • Radeberg, Germany, 01454
    • Withdrawn
    • Epilepsiezentrum Kleinwachau gemeinnützige Gmbh
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • Recruiting
    • Universitätsklinikum Ulm
• Israel
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah University Medical Center
  • Ramat Gan, Israel, 6265601
    • Recruiting
    • The Chaim Sheba Medical Center
  • Rehovot, Israel, 7661041
    • Recruiting
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Recruiting
    • The Tel Aviv Sourasky Medical Center
• Italy
  • Ancona, Italy, 60126
    • Withdrawn
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
  • Chieti, Italy, 66100
    • Recruiting
    • Università Degli Studi Gabriele d'Annunzio Di Chieti
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 185
    • Recruiting
    • Policlinico Umberto I
  • Roma, Italy, 00165
    • Recruiting
    • Ospedalo Pediatrico Bambino Gesu
• Mexico
  • Mexico City, Mexico, 03310
    • Active, not recruiting
    • Grupo Medico Camino Sc
  • Mexico City, Mexico, 14050
    • Active, not recruiting
    • Human Science Research Trials S. de R.L. de C.V.
  • Sinaloa, Mexico, 80020
    • Active, not recruiting
    • Neurociencias Estudios Clínicos S.C
• Netherlands
  • Heeze, Netherlands, 5591BL VE
    • Recruiting
    • Kempenhaeghe
• Poland
  • Bydgoszcz, Poland, 85-163
    • Recruiting
    • Centrum Medyczne Neuromed
  • Gdansk, Poland, 80-803
    • Recruiting
    • COPERNICUS Podmiot Leczniczy Sp. z o.o.
  • Katowice, Poland, 40-584
    • Recruiting
    • Novo-Med Zielinski I Wspolnicy Sp. J.
  • Lublin, Poland, 20-064
    • Withdrawn
    • NZOZ Neuromed M. i M.
  • Nowa Sól, Poland, 67-100
    • Recruiting
    • Twoja Przychodnia Nowosolskie Centrum Medyczne
• Portugal
  • Coimbra, Portugal, 3000-075
    • Recruiting
    • Centro Hospitalar Universitário de Coimbra (CHUC)
  • Guimarães, Portugal, 4835-044
    • Recruiting
    • Hospital da Senhora da Oliveira
  • Lisbon, Portugal, 1349-019
    • Recruiting
    • Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz
  • Lisbon, Portugal, 1649-035
    • Recruiting
    • Centre Hospitalar Universitario de Lisboa Norte (CHULN)
  • Matosinhos Municipality, Portugal, 4450-024
    • Recruiting
    • Unidade Local de Saúde de Matosinhos
  • Porto, Portugal, 4050-342
    • Recruiting
    • Centro Hospitalar Universitário de Santo António
  • Santa Maria da Feira, Portugal, 4520-211
    • Recruiting
    • Centro Hospitalar de Entre o Douro e Vouga
• Spain
  • Madrid, Spain, 280 41
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28010
    • Withdrawn
    • Hospital Universitario Vithas Madrid La Milagrosa
  • Málaga, Spain, 29010
    • Withdrawn
    • Hospital Regional Universitario de Malaga
  • Valladolid, Spain, 47003
    • Withdrawn
    • Hospital Clinico Universitario de Valladolid
  • Valparaíso, Spain, 2520612
    • Active, not recruiting
    • Hospital Clinico Vina del Mar
• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • Recruiting
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom, SW17 0QT
    • Recruiting
    • St George's University Hospitals NHS Foundation Trust
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • John Radcliffe Hospital
  • Salford, United Kingdom, M6 8HD
    • Recruiting
    • Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • Recruiting
      • University Hospital of Wales
  • West Yorkshire
    • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
      • Recruiting
      • Mid Yorkshire Hospitals NHS Trust
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Recruiting
      • University of Alabama - Strada Patient Care Center, Neurology
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Xenoscience
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona - Health Science Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
  • California
    • Los Angeles, California, United States, 90025
      • Recruiting
      • Brain Science Research Institute
    • Orange, California, United States, 92868
      • Recruiting
      • University of California, Irvine - Health Neurology Services
    • Sacramento, California, United States, 95817
      • Withdrawn
      • University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Serenity Research Center, LLC
    • Orlando, Florida, United States, 32806
      • Terminated
      • Research Institute of Orlando, LLC
    • Pensacola, Florida, United States, 32503
      • Recruiting
      • Panhandle Research and Medical Clinic
    • Port Charlotte, Florida, United States, 33952
      • Recruiting
      • Medsol Clinical Research Center Harbor Professional Centre
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University Of South Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Encore Medical Research of Weston, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory Brain Health Center
    • Suwanee, Georgia, United States, 30024
      • Withdrawn
      • Georgia Neurology & Sleep Medicine Associates
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Recruiting
      • Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center
  • Idaho
    • Boise, Idaho, United States, 83702
      • Recruiting
      • Consultants in Epilepsy and Neurology, PLLC
  • Illinois
    • Springfield, Illinois, United States, 62794
      • Recruiting
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Withdrawn
      • Indiana University School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Recruiting
      • Bluegrass Epilepsy Research, LLC
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Albert B. Chandler Hospital (UK Healthcare)
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21237
      • Recruiting
      • Medstar Franklin Square Medical Center
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Mid-Atlantic Epilepsy and Sleep Center
    • Clinton, Maryland, United States, 20735
      • Recruiting
      • MedStar Georgetown University Hospital
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Recruiting
      • Brigham and Women's Hospital
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Hospitals
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
    • East Lansing, Michigan, United States, 48824
      • Recruiting
      • Michigan State University Department of Neurology
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Spectrum Health
  • Missouri
    • St Louis, Missouri, United States, 14624
      • Recruiting
      • Saint Louis University Medical School
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Northeast Regional Epilepsy Group
  • New York
    • Amherst, New York, United States, 14226
      • Terminated
      • Dent Neurosciences Research Facility
    • Syracuse, New York, United States, 13201
      • Recruiting
      • SUNY Upstate Medical University
    • Woodmere, New York, United States, 11598
      • Withdrawn
      • Five Towns Neurology
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Atrium Health
    • Charlotte, North Carolina, United States, 28211
      • Recruiting
      • Onsite Clinical Solutions, LLC
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Clinical Research
    • Winston-Salem, North Carolina, United States, 27104
      • Recruiting
      • Wake Forest Baptist Health
  • Ohio
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Health Clinical Research Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth Riverside Methodist Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Comprehensive Epilepsy Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Withdrawn
      • Medical University of South Carolina (MUSC)
  • Texas
    • El Paso, Texas, United States, 79912
      • Recruiting
      • ANESC Research
    • Houston, Texas, United States, 77030
      • Recruiting
      • UTHealth Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Active, not recruiting
      • University of Utah Clinical Neurosciences Center
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Recruiting
      • Sentara Neurology Specialists
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington, Regional Epilepsy Center at Harborview Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Advocate Aurora Research institute, St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
3. Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned randomization (Visit 2), during screening/baseline, and throughout the DBP.
6. Subject is able to keep accurate seizure diaries.

Key Exclusion Criteria:

1. Subject has had status epilepticus within the 12 months prior to Visit 1.
2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
3. Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.
4. Subject has a concomitant diagnosis of focal-onset seizures (FOS).
5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
7. Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1.
8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.

9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:

   a. History or presence of long QT syndrome; QTcF >450 msec at baseline; family history of sudden death of unknown cause.

10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.

The criteria to be eligible for randomization are:

1. During the last 56 days that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization. Retrospective seizure data documented up to 4 weeks prior to Visit 1 may be used in combination with a minimum of 4 weeks of prospective seizure data recorded in the study eDiary.
2. Study eDiary was completed a minimum of 80% of all applicable days during the last 28-56 days of the baseline period that preceded randomization as evidence of adequate compliance (eg, >45 of 56 days, if no retrospective data prior to Visit 1 are used).
3. Subject did not change dose of, stop, or initiate any new ASM(s) during the 3 months that preceded randomization and plans on maintaining a stable dose of ASM(s) during the DBP.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsules
Experimental: XEN1101 25 mg/day	Drug: XEN1101; XEN1101 capsules; Other Names: Azetukalner
Experimental: XEN1101 15 mg/day	Drug: XEN1101; XEN1101 capsules; Other Names: Azetukalner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median percent change (MPC) in monthly (28 days) PGTCS frequency	Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.	Baseline through DBP (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects	Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.	Baseline through DBP (Week 12)
Proportion of subjects	Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo.	Baseline through Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	To assess the safety and tolerability of XEN1101 in subjects with PGTCS (e.g., adverse events).	From Screening Through to 56 Days Post-Final Dose

Collaborators and Investigators

• Sponsor: Xenon Pharmaceuticals Inc.
• Collaborators: Worldwide Clinical Trials
• Investigators: Study Director: Medical Director, Xenon Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Substandard Drugs; Pharmaceutical Preparations; XEN1101
• Other Study ID Numbers: XPF-010-303; 2022-502286-16-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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