Health TrialsbyHealthPanel

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

ConditionsEpilepsySeizures, Epileptic
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • SPN-817

    Drug

    oral capsule

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Open-Label TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effects of SPN-817 on safety and tolerability

The incidence of adverse events.

Time frame
72 weeks

Secondary outcomes

1

Effect of SPN-817 on the motor seizure frequency

Percent change from baseline in quantifiable motor seizure frequency per 28 days during treatment in the combined Titration/Optimization and Maintenance Periods, in the Maintenance Period, and in the combined Maintenance and Open-Label Extension Periods. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

Time frame
72 weeks
2

Effect of SPN-817 on the motor seizure frequency treatment response rate

The 30%, 50% and 75% motor seizure frequency treatment response rate during treatment in the combined Titration/Optimization and Maintenance Periods and in the Maintenance Period. The 30%, 50% or 75% seizure frequency treatment response rate is defined as the percent of subjects who have a ≥30%, ≥50%, or ≥75% reduction, respectively, in the change from baseline quantifiable motor seizure frequency. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

Time frame
20 weeks
3

Effect of SPN-817 on incidence of motor seizure-free days.

Change from Baseline in the percentage of quantifiable motor seizure-free days per 28 days during treatment. A "quantifiable motor seizure" is defined as a seizure adjudicated as probable and countable by the Epilepsy Study Consortium, Inc. (ESCI).

Time frame
72 weeks
4

Effect of SPN-817 on the Clinical Global Impression - Improvement (CGI-I) scale

CGI-I score by visit during treatment.

Time frame
72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Supernus Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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