A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients (NCT03239691) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
France, Germany5 participantsStarted 2017-10-06
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 suici…
What they're measuring
1
Individual evaluation of the response to intermittent photic stimulation