Recruiting at 1 site Early Phase 1 Epilepsy

Epilepsy study: Scopolamine

Official title Pharmacological Modulation of Brain Oscillations in Memory Processing

ClinicalTrials.gov ID: NCT05594017

What this study is testing

What is Scopolamine (0.4mg)?

This is an investigational medicine being studied to understand how it affects brain activity related to memory in people with epilepsy. It is designed to block certain chemical signals in the brain that help with forming and recalling memories.

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 is testing whether scopolamine changes how the brain handles new memories or old ones. It also looks at how the drug changes brain activity patterns.
Who it's for
You may be able to join if you have epilepsy and are already having brain surgery to check for seizures.
What's involved
You would get either the drug or a pretend liquid on two separate days. You would do memory games while researchers watch your brain activity.
Time commitment
The study takes two days, and you will already be in the hospital for your surgery.
  • Phase 1: an early, usually small safety study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 55. Healthy volunteers may be eligible.

You may be able to join if

  • Patient
  • Age 18 - 55 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...
  • 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...

You likely can't join if

  • Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound...
  • Female that is pregnant, breastfeeding, or has a positive pregnancy test at screening or baseline.
  • History of renal insufficiency.
  • Unstable cardiac syndrome or active cardiac symptoms.
  • Patients with liver failure.
  • Patients with BPH.
See the full eligibility criteria
Who can join
  • Patient
  • Age 18 - 55 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...
  • 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.
  • Body mass index between 18-35 kg/m2. Patient
What rules you out
  • 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.
  • History of renal insufficiency.
  • Unstable cardiac syndrome or active cardiac symptoms.
  • Patients with liver failure.
  • Patients with BPH.
  • Patients with autoimmune neuropathy.
  • Patients with uncontrolled hyperthyroidism.
  • Patients with a history of dementia.
  • Patient with a history of delirium after using transdermal scopolamine.
  • History of narrow-angle glaucoma.
  • History of pyloric obstruction or paralytic ileus.
  • History of myasthenia gravis, obstructive uropathy, porphyria, or myasthenia gravis.

The study team makes the final eligibility decision.

Where it is enrolling

  • Dallas, Texas, United States

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, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Dallas, Texas, United States. 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.