Clinical trial NCT03239691: A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
Official title: A Phase 2a, Multi-center, Single-blind, Within-subject, Placebo-controlled Study to Assess the Pharmacodynamics of ACT-709478 in Subjects With Photosensitive Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Photosensitive Epilepsy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility 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 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

Primary outcomes:
measure: Individual evaluation of the response to intermittent photic stimulation
timeFrame: From Day 2 to Day 10
Secondary outcomes:
measure: Time to onset of positive response
timeFrame: From Day 2 to Day 10
measure: Duration of positive response
timeFrame: From Day 2 to Day 10
measure: Maximum SPR reduction
timeFrame: From Day 2 to Day 10
measure: Time to maximum SPR reduction
timeFrame: From Day 2 to Day 10
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: HOSP - Bicêtre Neurologie
city: Bielefeld
country: Germany
facility: Bethel Epilepsy Center, Mara Hospital
city: Frankfurt
country: Germany
facility: Epilepsy Center Frankfurt
city: Kehl
country: Germany
facility: Epilepsiezentrum Kork
city: Radeberg
country: Germany
facility: Kleinwachau, Sächsisches Epilepsiezentrum Radeberg
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: