Trials Sponsors Conditions Drugs Pricing

Conditions

Epilepsy Seizures, Epileptic

Keywords

anti-seizure medicationepilepsyfocal seizuresPhase 2

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

EXPERIMENTAL

0.25 mg to 4 mg SPN-817 taken orally twice daily

Drug: SPN-817

Interventions

SPN-817Drug

oral capsule

Also known as: (-)-Huperzine A extended-release

Open-Label Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

Supernus Pharmaceuticals, Inc.
Industrylead

Study Sites (10)

Green Leaf Clinical Trials, LLC

Jacksonville, Florida, 32258, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Royal Prince Alfred Hospital

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Maciej Gasior, MD, PhD
Supernus Pharmaceuticals, Inc.
STUDY DIRECTOR

Central Study Contacts

Supernus Clinical Trials

CONTACT

240-403-5838 clinicaltrials@supernus.com

Navid Saiedi, MS

CONTACT

240-403-5328

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

Actual (reported)

Primary Completion

December 31, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Open-Label Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Open-Label Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations