NCT07228338 · Early Phase 1 · NOT YET RECRUITING
Cholinergic Enhancement of Theta
This small study tests whether Cobenfy (xanomeline and trospium, a drug approved for schizophrenia) changes brain activity tied to memory. Researchers record directly from the brain in people with epilepsy who already have electrodes implanted for seizure monitoring. It is an early Phase 1 study, meaning a first look at how the drug acts, not proof it helps memory.
You may qualify if
- Age 18 - 75 years, all races/ethnicities, and both genders are eligible.
- Candidates for pre-operative evaluation using stereo intracranial electrodes and admission to the Epilepsy Monitoring Unit (EMU) as determined independently by the patient's treating physician as part of the patient's routine medical care.
- Able to read, understand, and provide written, dated informed consent prior to screening.
- In good general health, aside from a history of epilepsy, as ascertained by medical history, physical examination (PE), clinical laboratory evaluations, and ECG.
You're excluded if
- Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to the study physician.
- Female that is pregnant, breastfeeding, or has a positive pregnancy test at screening or baseline. We note that pregnant patients are excluded from undergoing iEEG.
- Hepatic impairment (moderate or severe).
- Renal impairment (moderate or severe).
- Clinically significant bladder outlet obstruction or incomplete bladder emptying, such as patients with prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention.
- History of hypersensitivity to COBENFY or trospium chloride (angioedema risks).
- Untreated narrow-angle glaucoma.
- Biliary Disease (symptomatic gallstones, gallbladder disorders, pancreatitis).
- Strong Inhibitors of CYP2D6 such as fluoxetine, paroxetine, bupropion, terbinafine.
- Sensitive Substrates of CYP3A4 such as buspirone, eletriptan.
- Narrow Therapeutic Index Substrates of P-glycoprotein such as digoxin, colchicine, apixaban.
- Drugs Eliminated by Active Tubular Secretion.
- Antimuscarinic Drugs such as diphenhydramine, benztropine, oxybutynin.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-29