Primary Generalized Tonic-Clonic Seizures study: XEN1101
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?
This is an investigational capsule being studied as an add-on 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 study aims to find out if adding XEN1101 to current treatments makes seizures less frequent and if the medicine is safe to use.
- Who it's for
- The study is looking for people who have primary generalized tonic-clonic seizures (severe full-body convulsions).
- What's involved
- Participants will take either the new medicine or a placebo (sugar pill) along with their usual seizure medications and attend regular check-ups.
- Time commitment
- The study involves regular visits to the clinic over a set period to monitor health and seizure activity.
- 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 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...
- 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 is enrolling
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Springfield, Illinois, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Clinton, Maryland, United States
- Chestnut Hill, Massachusetts, United States
+ 72 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Jacksonville, Florida, United States and 86 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.