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

NCT ID: NCT03239691

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2018-04-25

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ACT-709478 - Single dose administration

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

Group Type: EXPERIMENTAL

ACT-709478 for oral use

Intervention Type: DRUG

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

Placebo

Placebo will be administered on two study days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo available as matching capsules for oral administration

Interventions

ACT-709478 for oral use

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

Intervention Type: DRUG

Placebo

Matching placebo available as matching capsules for oral administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

HOSP - Bicêtre Neurologie

Le Kremlin-Bicêtre, , France

Bethel Epilepsy Center, Mara Hospital

Bielefeld, , Germany

Epilepsy Center Frankfurt

Frankfurt, , Germany

Epilepsiezentrum Kork

Kehl, , Germany

Kleinwachau, Sächsisches Epilepsiezentrum Radeberg

Radeberg, , Germany

Countries

France; Germany

Other Identifiers

AC-083-103

Identifier Type: -

Identifier Source: org_study_id