Focal EpilepsyPhase 2ENACTNCT05481905
ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
A Phase 2 study testing ENX-101 in people with Focal Epilepsy, run by Engrail Therapeutics INC at 38 sites in United States.
Trial summary
The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- ENX-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 38 sitesUnited States
- Study dates
- Sep 2022to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years, inclusive, at Screening
- Diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification of Epilepsy, as confirmed by the Epilepsy Study Consortium
- Able to provide an imaging study(ies) [magnetic resonance imaging (MRI) scan strongly preferred yet computed tomography (CT) acceptable] obtained within the previous 10 years that can rule out a progressive cause of epilepsy
- During the 3 months (84 days) immediately prior to Screening:
- ≥ 3 observable focal onset seizures per 28-day period
- <10 seizures per day
Show all 14Show fewer
- Any seizure-free interval no more than 21 days in length,
- During the 8-week Baseline Period prior to Day 1:
- ≥ 6 observable focal onset seizures
- < 10 seizures per day
- No seizure-free interval of ≥ 21 days,
- Has been treated with antiseizure medications (ASMs) ≥ 2 years and currently being treated with:
- One to 4 ASMs at stable doses for at least 28 days before Screening (not including the rescue medication)
- Dose adjustments not expected during study
Who cannot join
- EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)
- Has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type
- Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome
- Has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to Screening
- Has history of psychogenic non-epileptic seizures
- Has history of status epilepticus within two years prior to Screening
Show all 11Show fewer
- Treatment of epilepsy with ASM was initiated < 2 years prior to Screening
- Ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to Screening
- Had epilepsy surgery for tissue resection < 1 year prior to Screening or radiosurgery < 2 years prior to Screening
- Had Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS), or other neurostimulation for epilepsy device implanted or activated < 1 year prior to Screening, stimulation parameters have been stable for < 3 months, or battery life of unit not anticipated to extend for duration of trial
- Initiated dietary therapy for epilepsy (e.g., ketogenic diet) < 3 months prior to Screening
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Advanced Clinical Research Center
Bridgeton, Missouri, 63044
NeuroScience Research Center, LLC
Canton, Ohio, 44718
Atrium Health
Chapel Hill, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Duke University School of Medicine
Durham, North Carolina, 27710
Oakland University William Beaumont School of Medicine
Farmington Hills, Michigan, 48334
University of Florida Research Institute of Orlando
Gainesville, Florida, 32611
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
University of Kansas
Kansas City, Kansas, 66160
Saint Joseph Health System
Lexington, Kentucky, 40504
Somnos Clinical Research/Neurology Associates
Lincoln, Nebraska, 68510
Institute of Neurology and Neurosurgery at Saint Barnabas LLC
Livingston, New Jersey, 07039
Royal Care Medical Research Corporation
Miami, Florida, 33032
University of Miami
Miami, Florida, 33136
D&H National Research Centers
Miami, Florida, 33155
S&G Research Center Corp.
Miami, Florida, 33155
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
New York, New York, 10016
Florida Hospital
Orlando, Florida, 32803
Comprehensive Neurology Clinic
Orlando, Florida, 32825
OSF HealthCare Illinois Neurological Institute
Peoria, Illinois, 61603
Thomas Jefferson University
Philadelphia, Pennsylvania, 42101
Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
SRI International
Plymouth, Michigan, 48170
University of Rochester
Rochester, New York, 14618
DJL Clinical Research
Rock Hill, South Carolina, 29732
Maine Medical Partners Neurology
Scarborough, Maine, 04074
Washington University School of Medicine
St Louis, Missouri, 63110
Mt. Olympus Medical Research
Sugar Land, Texas, 77479
Montefiore Medical Center
The Bronx, New York, 10467
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures
The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.
- Conditions
- Focal Epilepsy
- Being tested
- ENX-101
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENX-101Drug
Adjunctive treatment to current antiseizure medication
| Study group | Role | What they receive |
|---|---|---|
| ENX-101 15mg daily | Experimental | Not described Receives: Drug: ENX-101 |
| ENX-101 30mg daily | Experimental | Not described Receives: Drug: ENX-101 |
| Placebo daily | Placebo comparator | Not described Receives: Drug: ENX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo
Measured: Day 1 to end of the Treatment Period (Day 56) compared to placebo
Secondary outcomes (3)
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
The responder rate defined as the percent of patients who experience a 50% or greater reduction from baseline in seizure frequency in the Treatment Period compared to placebo (designated as primary for the European Medicines Agency)
Measured: Treatment Period (Day 1 to Day 56) compared to placebo
To evaluate the efficacy of ENX-101
The percent of patients who are seizure free during the last 28 days of the Treatment Period
Measured: Treatment Period (Day 29 to Day 56) compared to placebo
To evaluate the efficacy of ENX-101
The percent of patients who are seizure free during the entire Treatment Period
Measured: Treatment Period (Day 1 to Day 56) compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engrail Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481905
- Sponsor's protocol ID
- ENX-101-005
- Acronym
- ENACT
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures
- ClinicalTrials.gov ID
- NCT05481905
- Acronym / sponsor ID
- ENACT / ENX-101-005
- Conditions
- Focal Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Engrail Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Aug 2022 (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 ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ENX-101 15mg daily | Experimental | Drug: ENX-101 |
| ENX-101 30mg daily | Experimental | Drug: ENX-101 |
| Placebo daily | Placebo comparator | Drug: ENX-101 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged 18 to 75 years, inclusive, at Screening
- Diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification of Epilepsy, as confirmed by the Epilepsy Study Consortium
- Able to provide an imaging study(ies) [magnetic resonance imaging (MRI) scan strongly preferred yet computed tomography (CT) acceptable] obtained within the previous 10 years that can rule out a progressive cause of epilepsy
- During the 3 months (84 days) immediately prior to Screening:
- During the 8-week Baseline Period prior to Day 1:
Key exclusion criteria (11 listed)
- EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)
- Has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type
- Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome
- Has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to Screening
- Has history of psychogenic non-epileptic seizures
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 |
|---|---|---|
| ENX-101Adjunctive treatment to current antiseizure medication | Drug | ENX-101 15mg daily, ENX-101 30mg daily, Placebo daily |
Primary outcome
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
Time frame: Day 1 to end of the Treatment Period (Day 56) compared to placebo
The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo
3 secondary outcomes
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
Time frame: Treatment Period (Day 1 to Day 56) compared to placebo
To evaluate the efficacy of ENX-101
Time frame: Treatment Period (Day 29 to Day 56) compared to placebo
To evaluate the efficacy of ENX-101
Time frame: Treatment Period (Day 1 to Day 56) compared to placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENX-101 in people with Focal Epilepsy, run by Engrail Therapeutics INC at 38 sites in United States.
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 14 inclusion and 11 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: withdrawn, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures (time frame: Day 1 to end of the Treatment Period (Day 56) compared to placebo). 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 6 Jul 2023.