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The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-709478 - Single dose administration | Experimental | 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 | Placebo Comparator | Placebo will be administered on two study days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-709478 for oral use | Drug | Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of positive response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOSP - Bicêtre Neurologie | Le Kremlin-Bicêtre | 94275 | France | |||
| Bethel Epilepsy Center, Mara Hospital |
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| ID | Term |
|---|---|
| D020195 | Epilepsy, Reflex |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000707407 | ACT-709478 |
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| Placebo | Drug | Matching placebo available as matching capsules for oral administration |
|
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 |
| 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 |
| Time to maximum SPR reduction | From Day 2 to Day 10 |
| Bielefeld |
| 33617 |
| Germany |
| Epilepsy Center Frankfurt | Frankfurt | 60528 | Germany |
| Epilepsiezentrum Kork | Kehl | 77694 | Germany |
| Kleinwachau, Sächsisches Epilepsiezentrum Radeberg | Radeberg | 01454 | Germany |