Epilepsy
Primary objective: To assess the effect of XEN1101 versus placebo on reducing Primary generalized tonic-clonic seizure (PGTCS) frequency in subjects with PGTCS.
Key inclusion criteria
- ≥18 years
- Probable or possible PGTCS for ≥1 year
- Onset of PGTCS before age 40 years
- Subject must have had at least 3 PGTCS during the 8 weeks prior to Visit 1
Key exclusion criteria
- Subject has had status epilepticus within the 12 months prior to Visit 1
- History of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures could not be counted
- History of nonepileptic psychogenic seizures
- Presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome
- History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1
Sponsor: Xenon Pharmaceuticals Inc.
Primary objective: To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from the Observation Phase (OP) in 28-day average seizure frequency.
Key inclusion criteria
- 18-75 years
- Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit
- Drug Resistant Focal Onset Seizures
- History of an average of 4 or more observable focal seizures per month (28 days) during the 3 months prior to the screening visit
- Average of 4 or more observable focal seizures reported by subject and/or caregiver per 28 days in the 8-week OP
- During OP, subjects must not have 21 or more consecutive days without a focal seizure
- Body weight of > 40 kg at screening visit
Key exclusion criteria
- Exposure to non-biological investigational agents within 30 days or 5 half-lives (whichever is longer) prior to the screening visit
- Non-focal seizures defined by ILAE criteria
- Subject has seizures secondary to drug or alcohol use, ongoing infection
- Use of rescue medication more than 2 times within 1 month (28 days) in the last 3 months prior to the screening visit
- Use of rescue medication more than 2 times a month during the OP
- Resection neurosurgery for seizures < 4 months prior to the screening visit
- Radiosurgery performed < 2 years prior to the screening visit
Sponsor: Biohaven Pharmaceutical
Primary objective: To evaluate the safety and tolerability of BHV-7000
Key inclusion criteria
- Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303
Key exclusion criteria
- Participation in any other investigational clinical trial while participating in this clinical trial, excluding parent studies BHV7000-302 or BHV7000-303
- In the opinion of the Investigator, and in discussion with the Medical Monitors, due to a change in seizure type or pattern, participation in the study would not be beneficial to the subject
Sponsor: Biohaven Pharmaceutical
Primary objective: This is a single-center, open-label, prospective interventional study evaluating the safety and feasibility of the ExAblate Model 4000 Type-I focused ultrasound device for the creation of selective, unilateral, anterior nucleus (AN) ablation ipsilateral to the seizure onset in 10 adult patients with refractory, partial-onset epilepsy of temporal or frontotemporal onset, with or without secondary generalization, and comorbid moderate-to-severe anxiety over 3 years.
Key inclusion criteria
- Age 18-65 years
- Medically-refractory (uncontrolled seizures despite ≥ 2 anti-epileptic medication (AED) trials)
- Focal, or partial-onset seizures, localized to the temporal or frontotemporal regions, with or without secondary generalization
- Seizure frequency ≥ 3 seizures/month on average within 3 months of enrollment
Key exclusion criteria
- Generalized epilepsy or post-infectious epilepsy
- Presence of mesial temporal sclerosis or structural brain abnormalities (other than prior temporal lobectomy) that, based on PI assessment, would confound results, as visualized on 3T
- Presence of vagal nerve stimulator, deep brain stimulator, responsive neural stimulation
- Prior corpus callosotomy
Sponsor: Ohio State University
Primary objective: To evaluate the safety and tolerability of AMT-260 in adults with unilateral refractory MTLE over a period of 12 months
Key inclusion criteria:
- Age 18-65 years
- Diagnosis of unilateral refractory MTLE for ≥360 days, confirmed by an Epilepsy Monitoring Unit
- History of seizures with an average of ≥2 documented focal impaired awareness seizures or focal to bilateral tonic-clonic seizures per 30-day period over the 3-month Retrospective Period
- Failure of adequate trials of 2 tolerated and appropriately chosen and used ASD schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (drug-resistant epilepsy, as defined by the International League Against Epilepsy)
- No evidence of focal neurocognitive dysfunction, inconsistent with disease pathology-related MRI and/or (18F)FDG-PET findings
Key exclusion criteria
- Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted ≥3 months prior to Screening
- Any other contraindications for generalized anesthesia or surgery including background medications per local procedures
- Any known allergy to cyclic gadoteridol agents (e.g., ProHance®, Dotarem®, and Gadavist®).
- Dementia or other progressive neurological disorders and progressive brain lesions.
- Current diagnosis of cancer requiring treatment, or malignancy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
Sponsor: uniQure