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

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What is this study about?

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.

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.

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.

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.

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland

Other Sites

Site Name City Country Status
Novo-Med Zielinski I Wspolnicy Sp. j. Katowice Poland
Mtz Clinical Research Powered By Pratia Warsaw Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Medical Center Teodora EOOD Ruse Bulgaria
Neuroprotect Sp. z o.o. Warsaw Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Neurosphera Sp. z o.o. Warsaw Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Semmelweis University Budapest Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Pratia S.A. Skorzewo Poland
Insula Badania Sp. z o.o. Warsaw Poland
Mfjigbm Ctsdwe Awzdvyimy 2hju Eahq Pleven Bulgaria
Nqornibtgoem Zheqgl Oajydw Zlhirnbftz Ckwemrw Zlhgurd Suntiek Knurow Poland
Tutrf Cprmhrt Lmtrdakf Sopot Poland
Fxoec Cqigde Lnp Budapest Hungary
Nisomleoysvq Zuixsb Oittrn Zcdfhkyvjw Wkscwgzmqidqdsofgcfb Pdfpwqld Lzzxkbyt Szuqmhcw Lwdt Spptllyfxhau Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
31.07.2025
Hungary Hungary
Not yet recruiting
31.07.2025
Poland Poland
Not yet recruiting
31.07.2025

Trial locations

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.

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.

Trial ID:
2025-520587-18-00
Protocol code:
817P203
Trial Phase:
Therapeutic exploratory (Phase II)

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