Photosensitive EpilepsyPhase 2NCT03239691
A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
A Phase 2 study testing ACT-709478 for oral use in people with Photosensitive Epilepsy, run by Idorsia Pharmaceuticals Ltd. at 5 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Photosensitive Epilepsy
- What is being tested?
- ACT-709478 for oral use
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Oct 2017to 25 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Bethel Epilepsy Center, Mara Hospital
Bielefeld, 33617
Epilepsy Center Frankfurt
Frankfurt, 60528
Epilepsiezentrum Kork
Kehl, 77694
Kleinwachau, Sächsisches Epilepsiezentrum Radeberg
Radeberg, 01454
About this study
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
The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration
- Conditions
- Photosensitive Epilepsy
- Being tested
- ACT-709478 for oral use, Placebo
- Medical subject headings
- Epilepsy, Reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-709478 for oral useDrug
Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
PlaceboDrug
Matching placebo available as matching capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ACT-709478 for oral use |
| Placebo | Placebo comparator | Placebo will be administered on two study days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From Day 2 to Day 10
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: From Day 2 to Day 10
Time to maximum SPR reduction
Measured: From Day 2 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start6 Oct 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photosensitive EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239691
- Sponsor's protocol ID
- AC-083-103
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03239691
- Acronym / sponsor ID
- AC-083-103
- Conditions
- Photosensitive Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-709478 - Single dose administration | Experimental | Drug: ACT-709478 for oral useUp 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 | Drug: PlaceboPlacebo will be administered on two study days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-709478 for oral useHard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg | Drug | ACT-709478 - Single dose administration |
| PlaceboMatching placebo available as matching capsules for oral administration | Drug | Placebo |
Primary outcome
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)
4 secondary outcomes
Time to onset of positive response
Time frame: From Day 2 to Day 10
Duration of positive response
Time frame: From Day 2 to Day 10
Maximum SPR reduction
Time frame: From Day 2 to Day 10
Time to maximum SPR reduction
Time frame: From Day 2 to Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-709478 for oral use in people with Photosensitive Epilepsy, run by Idorsia Pharmaceuticals Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual evaluation of the response to intermittent photic stimulation (time frame: From Day 2 to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.