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New treatment option for Epilepsy
Official title Pharmacological Modulation of Brain Oscillations in Memory Processing
ClinicalTrials.gov ID: NCT05594017
What this study is testing
What is Scopolamine (0.4mg)?
Scopolamine (0.4mg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epilepsy.
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
- The goal of this study is to learn about the effects of scopolamine (an anticholinergic drug) on areas of the brain involved in memory, and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed.
- 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. Note that pregnant patients are excluded from...
- History of renal insufficiency.
- Unstable cardiac syndrome or active cardiac symptoms.
- Patients with liver failure.
- Patients with BPH.
See the full eligibility criteria
- 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
- 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. Note that pregnant patients are excluded from undergoing iEEG generally and all patients undergo a positive screening...
- 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's taking place
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.