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

Primary Purpose

Photosensitive Epilepsy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-709478 for oral use
Placebo
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Photosensitive Epilepsy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HOSP - Bicêtre Neurologie
  • Bethel Epilepsy Center, Mara Hospital
  • Epilepsy Center Frankfurt
  • Epilepsiezentrum Kork
  • Kleinwachau, Sächsisches Epilepsiezentrum Radeberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACT-709478 - Single dose administration

Placebo

Arm Description

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 will be administered on two study days

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to onset of positive response
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
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

Full Information

First Posted
August 2, 2017
Last Updated
August 30, 2018
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03239691
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
April 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photosensitive Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT-709478 - Single dose administration
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered on two study days
Intervention Type
Drug
Intervention Name(s)
ACT-709478 for oral use
Intervention Description
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo available as matching capsules for oral administration
Primary Outcome Measure Information:
Title
Individual evaluation of the response to intermittent photic stimulation
Description
Positive response described as complete suppression of photoparoxysmal response (PPR) or a clinically relevant reduction in the standardized photosensitive range (SPR)
Time Frame
From Day 2 to Day 10
Secondary Outcome Measure Information:
Title
Time to onset of positive response
Description
Defined by the first time point after ACT-709478 administration at which complete suppression of PPR or clinically relevant reduction in SPR is achieved
Time Frame
From Day 2 to Day 10
Title
Duration of positive response
Description
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
Time Frame
From Day 2 to Day 10
Title
Maximum SPR reduction
Description
Defined as the largest reduction in SPR achieved at any time point compared to baseline during the positive response after ACT-709478 administration
Time Frame
From Day 2 to Day 10
Title
Time to maximum SPR reduction
Time Frame
From Day 2 to Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
HOSP - Bicêtre Neurologie
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Bethel Epilepsy Center, Mara Hospital
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Epilepsy Center Frankfurt
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Epilepsiezentrum Kork
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Kleinwachau, Sächsisches Epilepsiezentrum Radeberg
City
Radeberg
ZIP/Postal Code
01454
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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