Status:
COMPLETED
A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Photosensitive Epilepsy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03239691
Start Date
October 6 2017
End Date
April 25 2018
Last Update
August 31 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
HOSP - Bicêtre Neurologie
Le Kremlin-Bicêtre, France, 94275
2
Bethel Epilepsy Center, Mara Hospital
Bielefeld, Germany, 33617
3
Epilepsy Center Frankfurt
Frankfurt, Germany, 60528
4
Epilepsiezentrum Kork
Kehl, Germany, 77694