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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03239691
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : August 31, 2018
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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

Condition or disease Intervention/treatment Phase
Photosensitive Epilepsy Drug: ACT-709478 for oral use Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : October 6, 2017
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : April 25, 2018

Arm Intervention/treatment
Experimental: ACT-709478 - Single dose administration
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
Drug: ACT-709478 for oral use
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg

Placebo Comparator: Placebo
Placebo will be administered on two study days
Drug: Placebo
Matching placebo available as matching capsules for oral administration

Primary Outcome Measures :
  1. Individual evaluation of the response to intermittent photic stimulation [ Time Frame: From Day 2 to Day 10 ]
    Positive response described as complete suppression of photoparoxysmal response (PPR) or a clinically relevant reduction in the standardized photosensitive range (SPR)

Secondary Outcome Measures :
  1. Time to onset of positive response [ Time Frame: From Day 2 to Day 10 ]
    Defined by the first time point after ACT-709478 administration at which complete suppression of PPR or clinically relevant reduction in SPR is achieved

  2. Duration of positive response [ Time Frame: From Day 2 to Day 10 ]
    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

  3. Maximum SPR reduction [ Time Frame: From Day 2 to Day 10 ]
    Defined as the largest reduction in SPR achieved at any time point compared to baseline during the positive response after ACT-709478 administration

  4. Time to maximum SPR reduction [ Time Frame: From Day 2 to Day 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03239691

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HOSP - Bicêtre Neurologie
Le Kremlin-Bicêtre, France, 94275
Bethel Epilepsy Center, Mara Hospital
Bielefeld, Germany, 33617
Epilepsy Center Frankfurt
Frankfurt, Germany, 60528
Epilepsiezentrum Kork
Kehl, Germany, 77694
Kleinwachau, Sächsisches Epilepsiezentrum Radeberg
Radeberg, Germany, 01454
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd. Identifier: NCT03239691     History of Changes
Other Study ID Numbers: AC-083-103
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epilepsy, Reflex
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases