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

NCT03239691 | Completed Phase 2

• 1 other identifier: AC-083-103
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 5

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

Conditions

Photosensitive Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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)

  From Day 2 to Day 10

Secondary Outcomes (4)

• Time to onset of positive response

  From Day 2 to Day 10

• Duration of positive response

  From Day 2 to Day 10

• Maximum SPR reduction

  From Day 2 to Day 10

• Time to maximum SPR reduction

  From Day 2 to Day 10

Study Arms (2)

ACT-709478 - Single dose administration

EXPERIMENTAL

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

Drug: ACT-709478 for oral use

Placebo

PLACEBO COMPARATOR

Placebo will be administered on two study days

Drug: Placebo

Interventions

ACT-709478 for oral use DRUG

Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg

ACT-709478 - Single dose administration

Placebo DRUG

Matching placebo available as matching capsules for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (5)

HOSP - Bicêtre Neurologie

Le Kremlin-Bicêtre, 94275, France

Location

Bethel Epilepsy Center, Mara Hospital

Bielefeld, 33617, Germany

Location

Epilepsy Center Frankfurt

Frankfurt, 60528, Germany

Location

Epilepsiezentrum Kork

Kehl, 77694, Germany

Location

Kleinwachau, Sächsisches Epilepsiezentrum Radeberg

Radeberg, 01454, Germany

Location

MeSH Terms

Conditions

Epilepsy, Reflex

Interventions

ACT-709478

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: October 6, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

DE (4); FR (1)