Recruiting

Study of SPN-817 (Huperzine A) in Adults with Focal Onset Seizures: Testing Safety and Effectiveness of Treatment

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with focal onset seizures, a type of epilepsy where seizures begin in one specific area of the brain. The research will test a medication called SPN-817 (also known as Huperzine A) in the form of oral capsules to determine if it can help control seizures in adults who have not responded well to other anti-seizure treatments.

The purpose of this research is to evaluate how well SPN-817 works as a treatment for adults with focal onset seizures, and to assess its safety and how well patients tolerate it. During the study, participants will receive either SPN-817 or placebo while continuing to take their current anti-seizure medications.

The treatment will involve taking capsules by mouth daily for several months. The medication dose may be adjusted during the initial period of the study, followed by a maintenance period where the dose remains stable. Throughout the study, participants will need to keep track of their seizures using an electronic diary and attend regular check-ups where their health will be monitored through various assessments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and baseline period
You will undergo an initial health assessment including physical examination, ECG (heart test), vital signs check, and laboratory tests.
You will need to record seizures in an electronic diary for a baseline period. At least 4 observable focal onset seizures must be documented during this time.
The electronic diary must be completed on at least 90% of baseline period days.
Step 2
Treatment period start
You will receive either SPN-817 (Huperzine A) or placebo in capsule form for oral use.
The medication must be taken whole without crushing, chewing, or cutting.
You will continue taking your current anti-seizure medications (1 to 4 medications) at stable doses.
Step 3
Titration and optimization period
Your medication dose may be adjusted during this period to find the optimal level.
Regular check-ups will monitor your response to treatment.
Step 4
Maintenance period
You will continue taking the study medication at the established dose.
Regular monitoring of seizure frequency will continue through the electronic diary.
Health assessments will be conducted at scheduled visits, including:
- Physical examinations
- Laboratory tests
- ECG measurements
- Quality of life questionnaires
Step 5
Study completion
Final health assessments will be performed.
The study is expected to run from July 2025 to August 2026.
After completing the study, you will need to wait 30 days (for females) or 90 days (for males) before discontinuing the required birth control methods.

Who can join the trial?

13 criteria

Must have treatment-resistant focal epilepsy confirmed by medical specialists
Must have tried at least 2 different anti-seizure medications without achieving seizure control
Age between 18 and 70 years
Must be able to understand and sign the consent form (or have a legal representative who can do this)
Must be able to maintain a daily electronic seizure diary (help from a caregiver is allowed)
Body Mass Index (BMI) must be between 18.0 and 40.0
Must be able to swallow capsules whole
Must be willing to attend all study visits and complete all required assessments
Must be taking 1 to 4 anti-seizure medications at stable doses for at least 28 days
Must have at least 4 observable seizures during the initial monitoring period
Must be in good general health based on medical examination
For women who can become pregnant: must use approved birth control methods throughout the study and for 30 days after
For men: must use approved birth control methods if having female partners who can become pregnant, continuing until 90 days after the study ends

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years
Pregnant or breastfeeding women
History of status epilepticus (prolonged or repeated seizures) within the past 12 months
Current use of more than 3 anti-seizure medications
Known allergies to similar anti-epileptic medications
Significant liver or kidney disease
Uncontrolled high blood pressure
History of substance abuse within the past 2 years
Major psychiatric disorders
Participation in another clinical trial within the past 30 days
History of non-compliance with medical treatments
Presence of a progressive neurological disorder (conditions where brain function gets worse over time)
Unstable medical conditions that could interfere with the study
Unable to provide informed consent
History of suicidal thoughts or attempts

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Cracow, Poland
Responsive
Semmelweis University
Budapest, Hungary
Verified
Synexus Polska Sp. z o.o.
Poznan, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

SPN-817 is an experimental medication being studied for treating adults who experience focal onset seizures, which are a type of epileptic seizure that starts in one area of the brain. This new drug is being tested to see if it can help reduce the frequency of seizures in patients who suffer from this condition. The medication is currently known by its development code name as it has not yet been assigned a standard generic name.

HUPERZINE A

What is already known about the treatment

SPN-817 - An investigational medication currently being studied in clinical trials for the treatment of focal onset seizures in adults. This novel drug is being evaluated through a double-blind, randomized, placebo-controlled study to determine its effectiveness, safety, and tolerability in patients with focal seizures. While the specific molecular mechanism and form of administration are not publicly disclosed in the current trial documentation, the medication is being investigated as a potential therapeutic option in the field of neurology, specifically targeting localized seizure activity in the brain. The drug belongs to the antiepileptic class of medications, though its precise pharmacological classification will be determined through ongoing clinical research.

Investigated diseases

Focal Onset Seizures - A type of epileptic seizure that begins in one area of the brain. These seizures start in a specific part of the brain and can cause various symptoms depending on which brain area is affected. The person may remain conscious or have altered awareness during the seizure. Symptoms can include involuntary movements, unusual sensations, or emotional changes. These seizures can vary in frequency and intensity, and may spread to involve both sides of the brain.