Actively Recruiting
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Led by Supernus Pharmaceuticals, Inc. · Updated on 2026-04-21
60
Participants Needed
10
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
CONDITIONS
Official Title
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of treatment resistant epilepsy confirmed by the Epilepsy Study Consortium
- Male or female aged 18 to 70 years at screening
- Able to read, understand, and sign the informed consent form (or have a legally authorized representative to do so)
- Able to keep accurate seizure diaries, with caregiver help if needed
- Weight within normal or overweight range (BMI 18.0 to 40 kg/m2)
- Able to swallow capsules whole without crushing, chewing, or cutting
- Willing to follow all study procedures and attend visits as scheduled
- Failure of at least two tolerated, appropriately chosen, and adequately dosed anti-seizure medication (ASM) regimens to achieve seizure freedom
- Taking at least one ASM at screening and baseline; stable diet plan for at least one month prior if applicable
- At least 4 countable seizures during the 42-day baseline diary period, with no seizure-free period longer than 21 days
- Clinical diagnosis of Focal Cortical Dysplasia Type I or II confirmed by recent neuroimaging or histopathology
- Good general health based on medical history, exams, ECG, and lab tests
- Able to comply with all study procedures; some exceptions may be approved case-by-case
- Non-pregnant females of childbearing potential using acceptable birth control methods or not at risk of pregnancy
- Males using two forms of contraception if partner is of childbearing potential, or surgically sterilized, and agreeing to avoid sperm donation during study
You will not qualify if you...
- Use of huperzine A within the past year
- Planning pregnancy, pregnant, nursing, or not using acceptable birth control
- Diagnosis of Lennox-Gastaut syndrome or nondiagnostic information
- Non-epileptic events that could be confused with seizures
- Seizures that are difficult to count or only seizure clusters
- History of status epilepticus within 6 months before screening
- Change in ASM regimen within 28 days before screening or during certain study periods
- Neurostimulation devices implanted or activated less than 1 year before screening or unstable stimulation parameters
- Recent suicidal behavior or ideation, or multiple suicide attempts
- Medical or psychiatric conditions interfering with study participation or safety
- Significant psychiatric disorders such as schizophrenia or bipolar disorder
- Alcohol or substance use disorder within past 2 years
- Clinically significant lab abnormalities or cardiologic issues at screening
- Abnormal kidney function or vital signs outside specified ranges
- History of significant allergic reactions to ASMs
- Recent blood donation exceeding specified amounts or low blood counts
- Current use of cholinergic non-ASM therapies before Visit 5
- Use of certain supplements or excessive intake of foods containing EGCG before first dose
- Participation in other clinical trials within 4 weeks or 5 half-lives of other investigational drugs
- HIV, Hepatitis B or C positive, or positive drug screen without valid prescription
- Any other condition deemed by investigator to prevent safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Green Leaf Clinical Trials, LLC
Jacksonville, Florida, United States, 32258
Actively Recruiting
2
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
4
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Completed
5
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Completed
6
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4006
Actively Recruiting
7
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
8
The Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
9
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
10
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
Research Team
S
Supernus Clinical Trials
CONTACT
N
Navid Saiedi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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