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 groupSponsors and collaborators
Source ClinicalTrials.gov