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New treatment option for Primary Generalized Tonic-Clonic Seizures
Official title A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
ClinicalTrials.gov ID: NCT05667142
What this study is testing
What is XEN1101?
XEN1101 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary generalized tonic-clonic seizures.
Also referred to as Azetukalner.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- 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...
- Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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 people) and for adolescent people parent/legal guardian and subject gives...
- 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...
- 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. Key
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Suwanee, Georgia, United States
- Honolulu, Hawaii, United States
- Boise, Idaho, United States
- Springfield, Illinois, United States
+ 104 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States and 118 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.