AzTrials
AzTrials

Primary Generalized Tonic-Clonic SeizuresPhase 3X-ACKTNCT05667142

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

A Phase 3 study testing XEN1101 in people with Primary Generalized Tonic-Clonic Seizures, run by Xenon Pharmaceuticals Inc. at 138 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
XEN1101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
138 sitesin 20 countries
Study dates
14 Feb 2023to Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
  • 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.
  • 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).
  • 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.
  • Subject is able to keep accurate seizure diaries.

Who cannot join

  • Subject has had status epilepticus within the 12 months prior to Visit 1.
  • Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
  • Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.
  • Subject has a concomitant diagnosis of focal-onset seizures (FOS).
  • Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
  • 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.
Show all 15Show fewer
  • Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1.
  • 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.
  • 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:
  • History or presence of long QT syndrome; QTcF >450 msec at baseline; family history of sudden death of unknown cause.
  • Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.
  • The criteria to be eligible for randomization are:
  • 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.
  • 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).
  • 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.

Trial locations and contacts

138 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Xenon Medical Affairs contact

1-604-484-3300

XenonCares@xenon-pharma.com

138 sites in 20 countries

United States59 sites, 45 recruiting

  • Summa Health Clinical Research Center

    Akron, Ohio, 44304

    Recruiting

  • Dent Neurosciences Research Facility

    Amherst, New York, 14226

    Terminated

  • University of Michigan Hospitals

    Ann Arbor, Michigan, 48109

    Recruiting

  • Emory Brain Health Center

    Atlanta, Georgia, 30329

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Withdrawn

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Recruiting

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

    Recruiting

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

    Recruiting

  • Consultants in Epilepsy and Neurology, PLLC

    Boise, Idaho, 83702

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Withdrawn

  • Atrium Health

    Charlotte, North Carolina, 28203

    Recruiting

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28211

    Recruiting

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • Medstar Georgetown University Hospital

    Clinton, Maryland, 20735

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Recruiting

  • Wayne State University

    Detroit, Michigan, 48201

    Recruiting

  • Duke University Clinical Research

    Durham, North Carolina, 27710

    Recruiting

  • Michigan State University Department of Neurology

    East Lansing, Michigan, 48824

    Recruiting

  • ANESC Research

    El Paso, Texas, 79912

    Recruiting

  • Spectrum Health

    Grand Rapids, Michigan, 49503

    Recruiting

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

    Recruiting

  • Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center

    Honolulu, Hawaii, 96817

    Withdrawn

  • UTHealth Science Center at Houston

    Houston, Texas, 77030

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

    Withdrawn

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • Bluegrass Epilepsy Research, LLC

    Lexington, Kentucky, 40504

    Recruiting

  • University of Kentucky Albert B. Chandler Hospital (UK Healthcare)

    Lexington, Kentucky, 40536

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Recruiting

  • Brain Science Research Institute

    Los Angeles, California, 90025

    Recruiting

  • Serenity Research Center, LLC

    Miami, Florida, 33176

    Recruiting

  • Advocate Aurora Research institute, St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Recruiting

  • University of Alabama - Strada Patient Care Center, Neurology

    Mobile, Alabama, 36604

    Withdrawn

  • University of California, Irvine - Health Neurology Services

    Orange, California, 92868

    Recruiting

  • Research Institute of Orlando, LLC

    Orlando, Florida, 32806

    Terminated

  • Panhandle Research and Medical Clinic

    Pensacola, Florida, 32503

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Withdrawn

  • Xenoscience

    Phoenix, Arizona, 85004

    Recruiting

  • UPMC Comprehensive Epilepsy Center

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Medsol Clinical Research Center Harbor Professional Centre

    Port Charlotte, Florida, 33952

    Withdrawn

  • University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)

    Sacramento, California, 95817

    Withdrawn

  • University of Utah Clinical Neurosciences Center

    Salt Lake City, Utah, 84132

    Active, not recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • University of Washington, Regional Epilepsy Center at Harborview Medical Center

    Seattle, Washington, 98104

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794

    Recruiting

  • Saint Louis University Medical School

    St Louis, Missouri, 14624

    Recruiting

  • Georgia Neurology & Sleep Medicine Associates

    Suwanee, Georgia, 30024

    Withdrawn

  • SUNY Upstate Medical University

    Syracuse, New York, 13201

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Recruiting

  • University of Arizona - Health Science Center

    Tucson, Arizona, 85724

    Recruiting

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

    Recruiting

  • Encore Medical Research of Weston, LLC

    Weston, Florida, 33331

    Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104

    Recruiting

  • Five Towns Neurology

    Woodmere, New York, 11598

    Withdrawn

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

    Withdrawn

Other trials in United States

Germany10 sites, 8 recruiting

  • Universitätsklinikum Aachen

    Aachen, D-52074

    Recruiting

  • Vivantes Humboldt Klinikum

    Berlin, 13509

    Withdrawn

  • Bethel Epilepsy Centre

    Bielefeld, 33617

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60528

    Recruiting

  • Epilepsiezentrum im Neuozentrum

    Freiburg im Breisgau, 79106

    Recruiting

  • Philipps-Universität Marburg

    Marburg, 35043

    Recruiting

  • Klinikum der Universität München

    München, 81377

    Recruiting

  • Epilepsiezentrum Kleinwachau gemeinnützige GmbH

    Radeberg, 01454

    Withdrawn

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

Portugal7 sites, 5 recruiting

  • Centro Hospitalar Universitário de Coimbra (CHUC)

    Coimbra, 3000-075

    Recruiting

  • Hospital da Senhora da Oliveira

    Guimarães, 4835-044

    Recruiting

  • Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz

    Lisbon, 1349-019

    Recruiting

  • Centre Hospitalar Universitario de Lisboa Norte (CHULN)

    Lisbon, 1649-035

    Recruiting

  • Unidade Local de Saúde de Matosinhos

    Matosinhos Municipality, 4450-024

    Recruiting

  • Centro Hospitalar Universitário de Santo António

    Porto, 4050-342

    Withdrawn

  • Centro Hospitalar de Entre o Douro e Vouga

    Santa Maria da Feira, 4520-211

    Withdrawn

Other trials in Portugal

Australia6 sites, 4 recruiting

  • Austin Health Pharmacy Clinical Trials

    Heidelberg, Victoria, 3084

    Recruiting

  • Southern Neurology

    Kogarah, New South Wales, 2217

    Withdrawn

  • The Alfred Hospital

    Melbourne, VC, 3004

    Recruiting

  • St Vincent's Hospital Melbourne, Clinical Neurosciences

    Melbourne, Victoria, 3065

    Withdrawn

  • The Royal Melbourne Hospital

    Parkville, 3050

    Recruiting

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

    Recruiting

Other trials in Australia

United Kingdom6 sites, 6 recruiting

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

    Recruiting

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, WC1N 3BG

    Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Recruiting

  • Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)

    Salford, M6 8HD

    Recruiting

  • Mid Yorkshire Hospitals NHS Trust

    Wakefield, West Yorkshire, WF1 4DG

    Recruiting

Other trials in United Kingdom

France5 sites, 5 recruiting

  • CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique

    Lille, 59037

    Recruiting

  • Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

    Lyon, 9003

    Recruiting

  • Hôpital Fondation A. de Rothschild

    Paris, 75019

    Recruiting

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033

    Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

    Recruiting

Other trials in France

Italy5 sites, 3 recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

    Ancona, 60126

    Withdrawn

  • Università Degli Studi Gabriele d'Annunzio Di Chieti

    Chieti, 66100

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Ospedalo Pediatrico Bambino Gesu

    Roma, 00165

    Recruiting

  • Policlinico Umberto I

    Roma, 185

    Withdrawn

Other trials in Italy

Poland5 sites, 4 recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163

    Recruiting

  • COPERNICUS Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

    Recruiting

  • Novo-Med Zielinski I Wspolnicy Sp. J.

    Katowice, 40-584

    Recruiting

  • NZOZ Neuromed M. i M.

    Lublin, 20-064

    Withdrawn

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    Nowa Sól, 67-100

    Recruiting

Other trials in Poland

Spain5 sites

  • Hospital Universitario 12 de Octubre

    Madrid, 280 41

    Withdrawn

  • Hospital Universitario Vithas Madrid La Milagrosa

    Madrid, 28010

    Withdrawn

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

    Withdrawn

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

    Withdrawn

  • Hospital Clinico Viña del Mar

    Valparaíso, 2520612

    Active, not recruiting

Other trials in Spain

Argentina4 sites, 1 recruiting

  • Hospital General de Agudos J.M. Ramos Mejia

    Buenos Aires, 1221

    Withdrawn

  • STAT Research S.A.

    Buenos Aires, C1023AAB

    Recruiting

  • Hospital Italiano

    Buenos Aires, C1181ACH

    Withdrawn

  • Sanatorio del Sur S.A

    San Miguel de Tucumán, 4000

    Active, not recruiting

Other trials in Argentina

Austria4 sites, 4 recruiting

  • University Hospital Innsbruck

    Innsbruck, 6020

    Recruiting

  • Universitaetsklinik fuer Kinder

    Linz, 4021

    Recruiting

  • Universitätsklinik für Neurologie

    Salzburg, 5020

    Recruiting

  • Universitätsklinik für Neurologie, Medizinische Universität Wien

    Vienna, 1090

    Recruiting

Other trials in Austria

Canada4 sites, 4 recruiting

  • Center for Neurologic Research

    Lethbridge, Alberta, T1J 0N9

    Recruiting

  • London Health Sciences Center

    London, Ontario, N6A5A5

    Recruiting

  • Le Centre Hospitalier de l'Universite' de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1

    Recruiting

  • Children and Women's Health Centre of BC (BC Children's Hospital)

    Vancouver, British Columbia, V6H 3V4

    Recruiting

Other trials in Canada

Israel4 sites, 4 recruiting

  • Hadassah University Medical Center

    Jerusalem, 9112001

    Recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan, 6265601

    Recruiting

  • Kaplan Medical Center

    Rehovot, 7661041

    Recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

Other trials in Israel

Bulgaria3 sites, 2 recruiting

  • Multiprofile hospital for active treatment Puls AD

    Blagoevgrad, 2700

    Recruiting

  • MHATNP 'Sveti Naum' EAD

    Sofia, 1113

    Recruiting

  • First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel

    Sofia, 1142

    Withdrawn

Other trials in Bulgaria

Croatia3 sites

  • Clinical Hospital Center Osijek

    Osijek, 310 00

    Withdrawn

  • Clinical Hospital Center Rijeka

    Rijeka, 510 00

    Withdrawn

  • University Hospital Center Zagreb

    Zagreb, 100 00

    Withdrawn

Other trials in Croatia

Mexico3 sites

  • Grupo Medico Camino SC

    Mexico City, 03310

    Active, not recruiting

  • Human Science Research Trials S. de R.L. de C.V.

    Mexico City, 14050

    Active, not recruiting

  • Neurociencias Estudios Clínicos S.C

    Sinaloa, 80020

    Active, not recruiting

Other trials in Mexico

Belgium2 sites, 2 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

Other trials in Belgium

Chile1 site

  • Centro de investigación Clinica UC-CICUC

    Santiago

    Active, not recruiting

Other trials in Chile

Czechia1 site

  • Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol

    Prague, 150 06

    Withdrawn

Other trials in Czechia

Netherlands1 site, 1 recruiting

  • Kempenhaeghe

    Heeze, 5591BL VE

    Recruiting

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
XEN1101, Placebo
Keywords
Epilepsy
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XEN1101Drug

    Also called Azetukalner

    XEN1101 capsules

  • PlaceboDrug

    Placebo capsules

Study groups in NCT05667142
Study groupRoleWhat they receive
XEN1101 25 mg/dayExperimentalXEN1101 25 mg/day
Receives: Drug: XEN1101
XEN1101 15 mg/dayExperimentalXEN1101 15 mg/day
Receives: Drug: XEN1101
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through DBP (Week 12)

Secondary outcomes (2)

  1. Proportion of subjects

    Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.

    Measured: Baseline through DBP (Week 12)

  2. Proportion of subjects

    Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo.

    Measured: Baseline through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start14 Feb 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667142
Sponsor's protocol ID
XPF-010-303
Other IDs
2022-502286-16-00
Acronym
X-ACKT
Status last verified
Oct 2026
First submitted
19 Dec 2022
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XEN1101 in people with Primary Generalized Tonic-Clonic Seizures, run by Xenon Pharmaceuticals Inc. at 138 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Germany, Portugal, Australia, United Kingdom and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xenon Medical Affairs (1-604-484-3300, XenonCares@xenon-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median percent change (MPC) in monthly (28 days) PGTCS frequency (time frame: Baseline through DBP (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05667142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in