Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
RENAISSANCE Study: A Phase 2, Multicenter, Open Label Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
1 other identifier
interventional
60
2 countries
10
Brief Summary
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2023
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 21, 2026
April 1, 2026
4.9 years
August 23, 2022
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of SPN-817 on safety and tolerability
The incidence of adverse events.
72 weeks
Secondary Outcomes (7)
Effect of SPN-817 on the motor seizure frequency
72 weeks
Effect of SPN-817 on the motor seizure frequency treatment response rate
20 weeks
Effect of SPN-817 on incidence of motor seizure-free days.
72 weeks
Effect of SPN-817 on the Clinical Global Impression - Improvement (CGI-I) scale
72 weeks
Effect of SPN-817 on the Clinical Global Impression - Severity (CGI-S) scale
72 weeks
- +2 more secondary outcomes
Study Arms (1)
Open-Label Treatment
EXPERIMENTAL0.25 mg to 4 mg SPN-817 taken orally twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +12 more criteria
You may not qualify if:
- 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.
- 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.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Green Leaf Clinical Trials, LLC
Jacksonville, Florida, 32258, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
The Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maciej Gasior, MD, PhD
Supernus Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 26, 2022
Study Start
February 7, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04