The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
5
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
Matching placebo available as matching capsules for oral administration
HOSP - Bicêtre Neurologie
Le Kremlin-Bicêtre, France
Bethel Epilepsy Center, Mara Hospital
Bielefeld, Germany
Epilepsy Center Frankfurt
Frankfurt, Germany
Epilepsiezentrum Kork
Kehl, Germany
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)
Time frame: From Day 2 to Day 10
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
Time frame: From Day 2 to Day 10
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
Time frame: From Day 2 to Day 10
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 frame: From Day 2 to Day 10
Time to maximum SPR reduction
Time frame: From Day 2 to Day 10
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Kleinwachau, Sächsisches Epilepsiezentrum Radeberg
Radeberg, Germany