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

Photosensitive Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239691
• Other study ID #: AC-083-103
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: August 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Photosensitive Epilepsy

Intervention

Drug:
• ACT-709478 for oral use
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
• Placebo
Matching placebo available as matching capsules for oral administration

Locations

Country	Name	City	State
France	HOSP - Bicêtre Neurologie	Le Kremlin-Bicêtre
Germany	Bethel Epilepsy Center, Mara Hospital	Bielefeld
Germany	Epilepsy Center Frankfurt	Frankfurt
Germany	Epilepsiezentrum Kork	Kehl
Germany	Kleinwachau, Sächsisches Epilepsiezentrum Radeberg	Radeberg

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From Day 2 to Day 10
Secondary	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	From Day 2 to Day 10
Secondary	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	From Day 2 to Day 10
Secondary	Time to maximum SPR reduction		From Day 2 to Day 10