Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSupernus Pharmaceuticals, Inc.
About this trial
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SPN-817
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
10Australia
Prince of Wales Hospital2031, RandwickNew South Wales, Australia
Royal Prince Alfred Hospital2050, SydneyNew South Wales, Australia
Westmead Hospital2145, SydneyNew South Wales, Australia
Royal Brisbane and Women's Hospital4006, BrisbaneQueensland, Australia
Sponsors and collaborators
Supernus Pharmaceuticals, Inc.
Lead sponsor
Source ClinicalTrials.gov