Photosensitive epilepsy
Conditions
Sponsors
Actelion 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) • 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 ; 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 ;Timepoint(s) of evaluation of this end point: From Day 2 to end-of-study; Primary end point(s): Individual evaluation of the response to IPS from Day 2 to end-of-study considering the following as positive response: • Complete suppression of PPR (defined by the absence of response at all frequencies tested) at least at 2 consecutive time points and in at least 1 eye condition with a minimum SPR of 3 at baseline (Day 1) OR • Clinically relevant response (SPR [defined as number of frequencies between the lower and upper limit that elicited a PPR] reduction of at least 3 units compared to baseline) at least at 2 consecutive time points and in at least 1 eye condition with a minimum SPR of 3 at baseline (Day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The time course and maximum IPS response, evaluated per eye condition as listed below, using the above mentioned definition for positive response: • Time to onset of positive response defined by the first time point after ACT-709478 administration at which complete suppression of PPR or reduction in SPR = 3 units compared to baseline is achieved at least at 2 consecutive time points • 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 end-of-study | — |
Countries
France, Germany
Contacts
Public ContactClinical Trial Disclosure Desk
Actelion Pharmaceuticals Ltd
Outcome results
None listed