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Trial record 4 of 12 for:    "Photosensitive Epilepsy"

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.
ClinicalTrials.gov Identifier: NCT03239691
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE October 6, 2017
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03239691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • 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
  • 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
  • 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
  • Time to maximum SPR reduction [ Time Frame: From Day 2 to Day 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
Official Title  ICMJE A Phase 2a, Multi-center, Single-blind, Within-subject, Placebo-controlled Study to Assess the Pharmacodynamics of ACT-709478 in Subjects With Photosensitive Epilepsy
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Photosensitive Epilepsy
Intervention  ICMJE
  • Drug: ACT-709478 for oral use
    Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
  • Drug: Placebo
    Matching placebo available as matching capsules for oral administration
Study Arms  ICMJE
  • 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
    Intervention: Drug: ACT-709478 for oral use
  • Placebo Comparator: Placebo
    Placebo will be administered on two study days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2017)
16
Actual Study Completion Date  ICMJE April 25, 2018
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03239691
Other Study ID Numbers  ICMJE AC-083-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idorsia Pharmaceuticals Ltd.
Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP