Photosensitive epilepsy
Conditions
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent in the local language prior to any study-mandated procedure • Male and female subjects aged between 18 and 60 years (inclusive) at screening • Photosensitive epilepsy and a generalized PPR in response to IPS of at least 4 units on a standardized photosensitive range (SPR) in at least 1 condition (eye closure, eyes closed, or eyes open) on 2 occasions at screening with at least 1 hour interval and reproducible on Day -1 (less than 3 units difference in SPR between screening and Day -1) • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a reliable method of contraception with a failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Lactating women • Known hypersensitivity to any of the excipients of the study treatment formulation • History or clinical evidence of any disease other than epilepsy and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed) • Relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (categories 4 or 5), or any suicidal behavior within the last 2 years, except for “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section), as judged by the investigator using the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening • History of status epilepticus during the last 12 months • History of non-epileptic seizures that cannot be differentiated from the participant’s epileptic seizures • History of generalized tonic-clonic seizures triggered by IPS • Previous history of repeated fainting, syncope, orthostatic hypotension, or vasovagal reactions in the past 5 years • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the pharmacodynamics by means of the change in intermittent photic stimulation (IPS)-induced photoparoxysmal response (PPR) in male and female subjects with photosensitive epilepsy following single dose administration of ACT-709478.;Timepoint(s) of evaluation of this end point: From Day 2 to Day 10; Secondary Objective: • To assess single-dose pharmacokinetics of ACT-709478 in male and female subjects with photosensitive epilepsy • To correlate plasma concentrations of ACT-709478 with the PD effect on the photosensitive range of IPS-induced PPR in subjects with photosensitive epilepsy • To assess the safety and tolerability of a single dose of ACT-709478 in subjects with photosensitive epilepsy ; Primary end point(s): Individual evaluation of the response to intermittent photic stimulation. Positive response described as complete suppression of photoparoxysmal response (PPR) or a clinically relevant reduction in the standardized photosensitive range (SPR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to onset of positive response, defined by the first time point after ACT-709478 administration at which complete suppression of PPR or clinically relevant reduction in SPR is achieved; • Duration of positive response, defined as the time elapsed between the time point of onset of the positive response and the last time point of the positive response after ACT-709478 administration; • Maximum SPR reduction, defined as the largest reduction in SPR achieved at any time point compared to baseline during the positive response after ACT-709478 administration; • Time to maximum SPR reduction. ;Timepoint(s) of evaluation of this end point: From Day 2 to to Day 10 | — |
Countries
France, Germany
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Outcome results
None listed