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EpilepsyPhase 2NCT05518578

Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

A Phase 2 study testing SPN-817 in people with Epilepsy and Seizures, Epileptic, run by Supernus Pharmaceuticals, Inc. at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Epilepsy, Seizures, Epileptic
What is being tested?
SPN-817
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
10 sitesin 2 countries
Study dates
7 Feb 2023to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of treatment resistant epilepsy as adjudicated by the Epilepsy Study Consortium.
  • Is male or female, aged 18 to ≤ 70 years at screening.
  • Is able to read, understand, and sign the Informed Consent Form (ICF). If the participant is unable to sign informed consent, a Legally Authorized Representative (LAR) will complete the ICF.
  • Ability to keep accurate seizure diaries (with the aid of a caregiver as needed).
  • Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 40 kg/m2).
  • Is able to swallow capsules whole without crushing, chewing, or cutting.
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  • Is willing to adhere to all study procedures and able to attend study visits within the specified time windows.
  • Failure of at least 2 tolerated, appropriately chosen and adequately dosed ASM drug schedules to achieve sustained seizure freedom.
  • Taking at least 1 ASM at Screening and Baseline. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to screening (Visit 1). The diet plan should be maintained throughout the duration of the study. Participants on a ketogenic diet will not be permitted to participate in the intense PK group.
  • At least 4 seizures accepted by the Epilepsy Study Consortium for the secondary outcome (adjudicated as "probable seizures" that are countable) during the 42-day baseline seizure diary period, and no more than a 21-day period that was seizure-free.
  • A clinical diagnosis of Focal Cortical Dysplasia (FCD) Type I or Type II (approximately n=10) confirmed by:
  • Likely FCD supported by neuroimaging that has been performed in the last 5 years, or
  • History of surgical resection of the cortical dysplasia that is histopathologically confirmed in patients who continue to have uncontrolled seizures without a compelling alternate explanation for ongoing seizures.
  • Note: The Epilepsy Study Consortium will review to confirm FCD/probable FCD diagnosis.
  • Be in good general health as per PI's judgment based upon medical history, physical exams, standard 12-lead ECG, and clinical laboratory evaluations obtained during the Screening Period
  • Be able to comply with and complete all study-specified procedures; enrollment for participants with limited ability to complete self-reported questionnaires or cognitive assessments may be permitted on a case-by-case basis after approval by the MM and Sponsor
  • Non-pregnant females of childbearing potential (FOCP) who are either in an exclusive same-sex relationship or sexually inactive (abstinent), or if sexually active with a male partner who is biologically capable of having children, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of SPN-817, throughout the study, and for 30 days following the last dose:
  • Simultaneous use of male condom and intra-uterine contraceptive device (IUD) placed at least 4 weeks prior to first SPN-817 administration
  • Surgically sterile male partner (6 months minimum)
  • Simultaneous use of any male barrier (condom) combined with any female barrier
  • Established hormonal contraceptive
  • Female participants are considered not to be of childbearing potential if they are either postmenopausal (amenorrhea for at least 2 years and serum follicle-stimulating hormone [FSH] level of >40 IU/L) or permanently sterilized (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy) for 6 months minimum.
  • Males must:
  • Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the screening visit to 90 days after the last dose of SPN-817, or
  • Have been surgically sterilized (6 months minimum) prior to the screening visit
  • Refrain from donating any sperm from the first administration of SPN-817 until 90 days after the last dose of SPN-817
  • Males who are in same-sex partner relationships or with those who are not biologically capable of having children are required to use a condom from the first dose through 7 days after the last dose of the SM.

Who cannot join

  • Has taken huperzine A within the past year
  • Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant, or nursing.
  • Participants with Lennox-Gastaut syndrome. Participants should also be excluded in case of nondiagnostic information.
  • Has non-epileptic events that could be confused by the patient and/or study staff as epileptic seizures.
  • Has only seizures that are difficult to count; for example, has seizures that are not clinically observable.
  • Has a history of only seizure clusters, for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
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  • Has a history of status epilepticus in the 6 months prior to Screening.
  • Change in ASM regimen in the last 28 days prior to screening. No changes in ASMs are allowed during the Screening, Titration/Optimization, or Maintenance Period. Changes in ASM regimen (including any diet plan used as an ASM) are allowed during the OLE Period only.
  • Vagus nerve stimulation (VNS), deep brain stimulation (DBS), responsive neurostimulator system (RNS), or other neurostimulation for epilepsy device implanted or activated <1 year prior to screening; stimulation parameters that have been stable for <3 months; or epilepsy surgery <1 year prior to screening.
  • Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening; a history of suicide attempt in the last 2 years; or more than 1 lifetime suicide attempt.
  • Any condition that may impact a patient's ability to follow study procedures or a patient's safety, based on what is known about the pharmacology/toxicology profile of the trial agent(s).
  • Has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder including brain tumor, active encephalitis, active meningitis or abscess) or takes medications that, in the PI's opinion, could interfere with the patient's suitability for participation in the study.
  • Has a history or evidence of current significant psychiatric disturbance (e.g., schizophrenia, schizoaffective, or bipolar disorder) that would preclude meaningful participation in the study procedures.
  • Has a history in the past 2 years or evidence of current alcohol and/or substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th edition.
  • Has had any clinical laboratory abnormalities within the 2 months prior to screening considered of clinical significance by the PI.
  • Is human immunodeficiency virus (HIV)/Hepatitis B/Hepatitis C positive or has a positive urine drug screen (UDS) with the following considerations:
  • Participants who have a diagnosis of cannabis use disorder (per DSM-5) within 6 months before Screening and have a positive UDS for cannabis at Screening will be excluded. At the discretion of the Sponsor, recreational use of cannabis is allowed and should be kept consistent during the study. Participants must agree to refrain from using cannabis 48 h prior to the study visits.
  • Cannabis (including cannabidiol [CBD] products) prescribed for a medical condition or used as an ASM is allowed if taken at a stable regimen for at least 28 days prior to Screening. Newly prescribed cannabis treatment and/or a change to the existing regimen is prohibited. When applicable, participants should show proof of their prescription for medical cannabis.
  • Participants who also test positive for specific medications (benzodiazepines, amphetamines, etc.) must show proof of the prescription and should not be excluded due to a positive UDS if the positive UDS is related to a prescribed medication.
  • Is on concomitant therapy with non-ASMs that are cholinergic prior to Visit 5
  • Is currently taking or within the 3 days prior to first administration of SPN-817 has taken over-the-counter supplements containing epigallocatechin gallate (EGCG) such as concentrated green tea extracts or products containing synthetic EGCG, or foods containing > 100 grams of carob powder. Also current or within the 3 days prior the first administration of SPN-817, excessive consumption (> 3 cups per day) of foods or drinks containing EGCG (eg, all green, white, or oolong teas and all black teas) is prohibited.
  • Has participated in any clinical investigational drug or device study within 4 weeks prior to study entry or within 5 half-lives of the clinical investigational drug, whichever is longer.
  • Clinically significant cardiologic abnormalities at screening. One repeat assessment is allowed per Investigator discretion.
  • Abnormal ECG that is, in the Investigator's opinion, clinically significant including:
  • Heart rate (HR) <50 bpm
  • PR interval >220 ms
  • QRS interval ≥120 ms
  • QTcF (QT interval corrected for heart rate using Fridericia's method) >450 ms for males and >470 ms for female participants
  • Second or third-degree atrioventricular block
  • Any rhythm, other than sinus rhythm, that is interpreted by the Investigator to be clinically significant
  • Has abnormal renal function as demonstrated by estimated glomerular filtration rate (eGFR) of <60 mL/min according to the eGFR Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening.
  • Clinically significant vital signs abnormalities (systolic blood pressure <90 or >140 mmHg, diastolic blood pressure <50 or >90 mmHg, or HR <50 or >100 bpm) at screening.
  • Participant has had >2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM.
  • Participants who donated 50-499 mL of blood within 30 days or >499 mL within 56 days prior to Day 1 administration or have hemoglobin <128 g/L (male) or <115 g/L (female) and hematocrit <0.37 L/L (males) or <0.32 L/L (female) at screening. Following screening and throughout the study, participants should not donate blood.
  • Any reason which, in the opinion of the PI, would prevent the participant from participating in the study.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Supernus Clinical Trials contact

240-403-5838

clinicaltrials@supernus.com

Navid Saiedi, MS contact

240-403-5328

nsaeidi@supernus.com

10 sites in 2 countries

Australia8 sites, 6 recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Recruiting

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4006

    Recruiting

  • The Austin Hospital

    Heidelberg, Victoria, 3084

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Jack Germaine, +61 3 9076 2029, J.Germaine@alfred.org.au

    Terence O'Brien, MD

    Recruiting

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

    Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

    Completed

  • Westmead Hospital

    Sydney, New South Wales, 2145

    Completed

Other trials in Australia

United States2 sites, 2 recruiting

  • Green Leaf Clinical Trials, LLC

    Jacksonville, Florida, 32258

    Recruiting

  • Visionary Investigators Network

    Miami, Florida, 33133

    Recruiting

Other trials in United States

About this study

Official title: RENAISSANCE Study: A Phase 2, Multicenter, Open Label Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures

Read the detailed description

This is a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 (huperzine A, an acetylcholinesterase inhibitor) in adults 18-70 years of age with treatment resistant epilepsy. The Screening period is up to 8 weeks in duration, followed by a Titration Period of 9 weeks and a Maintenance Period of 12 weeks (total Treatment Period of 21 weeks) for eligible participants. The Treatment Period will be followed by an optional Open-Label Extension period which is up to 52 weeks in duration. Schedule A will enroll participants with treatment resistant seizures, and Schedule B will enroll with treatment resistant seizures who will receive SPN-817 along with a concomitant medication to assess pharmacological approaches to managing cholinergic AEs.

Being tested
SPN-817
Keywords
anti-seizure medication, epilepsy, focal seizures, Phase 2
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPN-817Drug

    Also called (-)-Huperzine A extended-release

    oral capsule

Study groups in NCT05518578
Study groupRoleWhat they receive
Open-Label TreatmentExperimental0.25 mg to 4 mg SPN-817 taken orally twice daily
Receives: Drug: SPN-817

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of SPN-817 on safety and tolerability

    The incidence of adverse events.

    Measured: 72 weeks

Secondary outcomes (7)

  1. Effect of SPN-817 on the motor seizure frequency

    Percent change from baseline in quantifiable motor seizure frequency per 28 days during treatment in the combined Titration/Optimization and Maintenance Periods, in the Maintenance Period, and in the combined Maintenance and Open-Label Extension Periods. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

    Measured: 72 weeks

  2. Effect of SPN-817 on the motor seizure frequency treatment response rate

    The 30%, 50% and 75% motor seizure frequency treatment response rate during treatment in the combined Titration/Optimization and Maintenance Periods and in the Maintenance Period. The 30%, 50% or 75% seizure frequency treatment response rate is defined as the percent of subjects who have a ≥30%, ≥50%, or ≥75% reduction, respectively, in the change from baseline quantifiable motor seizure frequency. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

    Measured: 20 weeks

  3. Effect of SPN-817 on incidence of motor seizure-free days.

    Change from Baseline in the percentage of quantifiable motor seizure-free days per 28 days during treatment. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

    Measured: 72 weeks

  4. Effect of SPN-817 on the Clinical Global Impression - Improvement (CGI-I) scale

    CGI-I score by visit during treatment.

    Measured: 72 weeks

  5. Effect of SPN-817 on the Clinical Global Impression - Severity (CGI-S) scale

    Change from Baseline in the CGI-S score by visit during treatment.

    Measured: 72 weeks

  6. Effect of SPN-817 on the Quality of Life in Epilepsy (QOLIE-31-P; v2.0) questionnaire

    Change from Baseline in QOLIE-31-P score by visit during treatment.

    Measured: 72 weeks

  7. Effect of SPN-817 on the Seizure Related Disability Assessment Scale (SERDAS) scale

    Change from Baseline in SERDAS score by visit during treatment.

    Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start7 Feb 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518578
Sponsor's protocol ID
817P202
Status last verified
Apr 2026
First submitted
23 Aug 2022
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPN-817 in people with Epilepsy and Seizures, Epileptic, run by Supernus Pharmaceuticals, Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Supernus Clinical Trials (240-403-5838, clinicaltrials@supernus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of SPN-817 on safety and tolerability (time frame: 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05518578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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