A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients

Phase 2

Completed

• Conditions: Photosensitive Epilepsy
• Interventions: Drug: ACT-709478 for oral use; Drug: Placebo

• Registration Number: NCT03239691
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-04
• Study Start: 2017-10-06
• Primary Completion: 2018-04-25
• Study Completion: 2018-04-25
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACT-709478 - Single dose administration	ACT-709478 for oral use	Up to 16 subjects with photosensitive epilepsy will be studied across a maximum of 4 dose levels. Each dose level will initially be investigated in cohorts of 4 subjects undergoing a fixed sequence of study treatment administration in fed condition
Placebo	Placebo	Placebo will be administered on two study days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Kleinwachau, Sächsisches Epilepsiezentrum Radeberg; 🇩🇪 Radeberg, Germany

Epilepsy Center Frankfurt; 🇩🇪 Frankfurt, Germany

HOSP - Bicêtre Neurologie; 🇫🇷 Le Kremlin-Bicêtre, France

Bethel Epilepsy Center, Mara Hospital; 🇩🇪 Bielefeld, Germany

Epilepsiezentrum Kork; 🇩🇪 Kehl, Germany