RecruitingPhase 3interventionalRules rewrite

Phase 3: testing XEN1101 for Primary Generalized Tonic-Clonic Seizures

Q: Is NCT05667142 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05667142?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05667142?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).

Official registry: https://clinicaltrials.gov/study/NCT05667142 · Xenon Pharmaceuticals Inc. · enrollment listed as 160

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are XEN1101, or Placebo. The registry lists allocation as randomized. This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).

They plan to enroll about 160 people at 141 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: XEN1101, Placebo

Primary outcome (registry wording): Median percent change (MPC) in monthly (28 days) PGTCS frequency

Who it is for (from inclusion criteria)

Ages 12 Years to any
Subject is ≥12 years of age with a body-mass index (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 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 the registry excludes

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
Subject has history of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to Visit 1

Public study contact (from the registry)

Xenon Medical Affairs

1-604-484-3300

XenonCares@xenon-pharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

141 listed

University of Alabama - Strada Patient Care Center, Neurology — Mobile, Alabama (withdrawn)
Xenoscience — Phoenix, Arizona (recruiting)
University of Arizona - Health Science Center — Tucson, Arizona (recruiting)
University of Arkansas for Medical Sciences — Little Rock, Arkansas (recruiting)
Brain Science Research Institute — Los Angeles, California (recruiting)
University of California, Irvine - Health Neurology Services — Orange, California (recruiting)
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC) — Sacramento, California (withdrawn)
University of Colorado Anschutz Medical Campus — Aurora, Colorado (withdrawn)
Mayo Clinic Florida — Jacksonville, Florida (recruiting)
Serenity Research Center, LLC — Miami, Florida (recruiting)
Orlando Health Neuroscience Institute — Orlando, Florida (recruiting)
Research Institute of Orlando, LLC — Orlando, Florida (terminated)

+ 79 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Not a traditional drug phase: Laboratory tests for Neurologic Disorders

Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.

NCT00060541 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)

RecruitingNot a traditional drug phaseBethesda, Maryland

Surgery as a Treatment for Medically Intractable Epilepsy

Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery.

NCT01273129 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)

RecruitingNot a traditional drug phaseSioux Falls, South Dakota

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.

NCT01793168 · Official ClinicalTrials.gov record · Sanford Health

FAQ about this NCT record

Is NCT05667142 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05667142?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05667142?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary