Photosensitive Epilepsy
Conditions
Brief summary
The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration
Interventions
DRUGACT-709478 for oral use
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
DRUGPlacebo
Matching placebo available as matching capsules for oral administration
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 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 \<1% per year, be sexually inactive, or have a vasectomized partner. Hormonal contraceptives must be initiated at least 1 month before first study treatment administration
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 | Description |
|---|---|---|
| Individual evaluation of the response to intermittent photic stimulation | From Day 2 to Day 10 | 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 | Description |
|---|---|---|
| Time to onset of positive response | From Day 2 to Day 10 | 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 | From Day 2 to Day 10 | 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 | From Day 2 to Day 10 | 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 | From Day 2 to Day 10 | — |
Countries
France, Germany
Outcome results
None listed