Focal Onset SeizuresPhase 2NCT05473442
Study of EQU-001 for Uncontrolled Focal Onset Seizures
A Phase 2 study testing EQU-001 in people with Focal Onset Seizures, run by Equilibre Biopharmaceuticals B.V. at 13 sites in 2 countries.
Trial summary
This study is a Phase 2 multinational, double-blind, placebo-controlled, randomized (1:1:1), efficacy and safety study of adjunctive EQU-001 for the treatment of focal onset seizures in subjects aged 18 to 65 years, who have been diagnosed with epilepsy according to International League Against Epilepsy (ILAE)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Onset Seizures
- What is being tested?
- EQU-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 27 Dec 2022to 1 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 65 years at time of informed consent
- The subject or designee is willing and able to keep an accurate study diary, the subject is able to adhere to the protocol, the subject or the subject's legal representative is able read, understand, and sign informed consent, as applicable.
- Diagnosed with focal epilepsy according to ILAE (2017) criteria. Diagnosis to include clinical history and an EEG consistent with focal epilepsy. A normal interictal EEG is allowed when the clinical history is consistent with focal epilepsy.
- Subject has no seizures that are not focal by the ILAE 2017 criteria
- Subject must have 8 countable, observable focal seizures during the 8-week baseline period prior to randomization, including at least 3 in each 4-week period with no 21-day seizure-free period. These seizures must be observable (focal aware with motor component, focal impaired awareness, focal to bilateral tonic-clonic) and as such may not include focal aware seizures without a detectable motor component, aphasia, or other observable symptom.
- Must have had a brain MRI or contrast-enhanced head CT scan with an available report (images need not be available) that has been performed within the past 10 years and that is negative for confounding conditions such as tumor, infection, demyelinating disease, or other progressive neurological disease. Remote stroke that may represent the etiology for epilepsy is allowed. If no such CT or MRI report is available, a potential subject will be asked to undergo a head CT scan with intravenous contrast to meet eligibility criteria prior to study enrollment.
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- Seizures uncontrolled after an adequate trial of at least 1 ASM within the last 2 years.
- Currently receiving treatment with 1-3 ASMs with doses stable for at least 4 weeks prior to screening. These medications must stay stable during the 8-week baseline period and during the 16-week treatment period. In the case that the plasma level of a concomitant ASM changes, the subject and their physician may then modify the dose to maintain the plasma level that was present prior to beginning the study drug. and must document the change in the EDC system.
- If participant has a vagal nerve stimulator (VNS), responsive neurostimulator (RNS) or deep brain stimulator (DBS), it must have been implanted and activated >1 year prior to screening, and stimulation parameters that have been stable for >3 months, and battery life of unit anticipated to extend for duration of trial.
- Females of childbearing potential who are not sexually inactive (abstinent) for 30 days prior to the first dose, throughout the study, and then for 30 days following the last dose, must agree to use of one of the following acceptable birth control methods from 30 days prior to the first dose through 30 days after the last dose of study drug:
- Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) together with a condom or other barrier method ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) together with a condom or other barrier method iii. Intrauterine device (IUD) together with a condom or other barrier method iv. Intrauterine hormone releasing system (IUS) together with a condom or other barrier method v. Bilateral tubal occlusion, hysterectomy, bilateral oophorectomy vi. Vasectomized partner (vasectomy >6 months ago)
- For this study, pre-menopausal is defined as not meeting the clinical criteria for post menopausal, that is, no menstrual period for at least one year, in the absence of other identifiable cause(s) of not having a period, together with the absence of typical symptoms of menopause, such as hot flashes and mood instability. True abstinence is allowable when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Pregnant or lactating
- History of hypersensitivity to ivermectin or to any of the excipients in the EQU-001 gelcap
- History of status epilepticus in the past 1 year from screening
- History of pseudo- or nonepileptic seizures, or other nonepileptic events that could be confused with epileptic seizures, within the past 5 years
- History of traumatic brain injury within 30 days prior to screening
- Resective epilepsy surgery within 1 year; epilepsy-related radiosurgery within 2 years or Ventriculoperitoneal shunt placement within 1 year
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- Presence of progressive neurological disorder or other progressive disorder or unstable medical condition(s) that may confound study results. History of long QT syndrome, family history of sudden death of unknown cause.
- Psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study or which would interfere with the subject's ability to participate in the trial
- Active suicidal plan/intent in the past 6 months, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt as evidenced by a positive response to C-SSRS questions 4 or 5
- History of substance use disorder, including alcohol, within the past 2 years
- Currently in another investigational drug study
- Currently on felbamate for less than one year before visit 1 (aplastic anemia and hepatic failure usually occur within 6 months to one year). If on felbamate, documentation of stable hemogram and liver enzyme tests must be present.
- Currently on vigabatrin for less than 2 years before visit 1, as most visual field changes occur between 6 months and 2 years Subjects on vigabatrin should have available, appropriate documentation of visual fields.
- Currently taking retigabine/ezogabine
- History of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) more than once in the 4 weeks prior to the baseline visit or more than once per 4 weeks during the 8-week baseline period If a subject is taking benzodiazepines for an indication other than epilepsy (e.g., anxiety, sleep), the dose should to be stable for at least 4 weeks prior to screening and remain stable throughout screening and double blind periods of the study.
- Currently taking ivermectin, or has taken it within the last 4 weeks prior to visit 1
- 17a. Use of the following medications within 4 weeks of the baseline visit and throughout the study that may interfere with study drug metabolism (please note ASMs with CYP3A4 metabolism are not excluded from this study, as drug levels and safety are monitored throughout the study):
- CYP3A4 inducers: rifampin, lumacaftor, mitotane, enzalutamide, apalutamide, St. John's wort, glucocorticoids
- Medications with PGP interactions: amiodarone, apalutamide, verapamil, lorlatinib, rifampin, St. John's wort
- 17b. Use of the following medications/foods is not strictly prohibited but is discouraged. Please make every attempt to refrain and to record each incidence of use of any of these (along with all medications and supplements):
- CYP3A4 inhibitors, including, but not limited to clarithromycin, ceritinib, idelalisib, lonafarnib, tucatinib, erythromycin, telithromycin, diltiazem, dronedarone, posaconazole, voriconazole, nefazodone, itraconazole, ketoconazole, anti-retroviral drugs (atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir), grapefruit and grapefruit juice, pomegranate fruit and pomegranate juice
- Additional medications that may interact with CYP3A4, PGP, or Vitamin K: fluconazole, isavuconazole, cyclosporine, dronedarone, imatinib, warfarin, acenocoumarol
- 18. Has any of the following laboratory or exam abnormalities: i. Positive urine drug screen (methamphetamines, amphetamines, cocaine, PCP, opioids, barbiturates) at screening without a therapy related explanation ii. Positive hCG (female participants) (at screening or visit 2/enrollment) iii. QTcF > 450 msec at visit 2/enrollment
- 19. Subject is not approved for study inclusion by the Epilepsy Consortium based on the diagnostic review form
- 20. Any condition that, in the opinion of the investigator, may impact a subject's safety or ability to follow study procedures
- 21. History of 14 or more consecutive days in Angola, Equatorial Guinea, Gabon, Cameroon, the Central African Republic, the Republic of Congo, the DR of Congo, Nigeria, Chad, and/or South Sudan within the past 17 years and did not take diethylcarbamazine prophylaxis or has not been evaluated for/found to be negative for or treated for loa loa and subsequently evaluated as resolved since the most recent stay of at least 14 days.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702
University of Virginia
Charlottesville, Virginia, 22903
Northwest Houston Neurology
Cypress, Texas, 77429
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, 07039
NYU Langone Health
New York, New York, 10016
Sooner Clinical Research, Inc.
Oklahoma City, Oklahoma, 73112
Comprehensive Epilepsy Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Israel5 sites
Ramban Health Care Campus
Haifa, 3109601
Hadassah Medical Center
Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, 4941492
Chaim Sheba Medical center
Ramat Gan, 5262000
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures
This study is a Phase 2 multinational, double-blind, placebo-controlled, randomized (1:1:1), efficacy and safety study of adjunctive EQU-001 for the treatment of focal onset seizures in subjects aged 18 to 65 years, who have been diagnosed with epilepsy according to International League Against Epilepsy (ILAE) Classification of the Epilepsies 2017 criteria This study is designed to test the efficacy and safety of EQU-001 20 mg and 60 mg as compared with placebo as an add-on anti-seizure medication (ASM) in subjects with uncontrolled focal onset seizures.
The treatment portion of the study will be comprised of a 4-week double-blind medication activation period and a 12-week double-blind maintenance period.
- Conditions
- Focal Onset Seizures
- Being tested
- EQU-001, Matching Placebo
- Keywords
- EQU-001, Epilepsy, Seizures, Focal, Phase II
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQU-001Drug
20 mg pills of EQU-001
Matching PlaceboOther
20 mg matching placebo pills
| Study group | Role | What they receive |
|---|---|---|
| EQU-001 60 mg | Experimental | EQU-001 60 mg (3 x 20 mg pills) Receives: Drug: EQU-001 |
| EQU-001 20 mg | Experimental | EQU-001 20 mg (1 x 20 mg pill + 2 x matching placebo pills) Receives: Drug: EQU-001; Other: Matching Placebo |
| EQU-001 0 mg | Placebo comparator | EQU-001 0 mg (3 x matching placebo pills) Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median percentage change in the overall number of countable observable seizures
per 28-day period relative to baseline in each treatment arm during the double-blind treatment period compared with placebo.
Measured: Every 4 weeks from week 1 up to week 16
Secondary outcomes (12)
Median percentage change in the overall number of countable observable seizures
per 28-day period relative to baseline in each treatment arm during the maintenance phase compared with placebo
Measured: Every 4 weeks from week 5 up to week 16
≥ 50% responder rates
In the treated arms as compared with placebo during double blind components of the study, which consist of the medication activation and maintenance period
Measured: Week 1 to 16
≥ 50% responder rates
In the treated arms as compared with placebo during the maintenance period alone
Measured: Week 5 to 16
Difference in PGI-C Scale: Patient's Global Impression of Change (PGIC)
In each treated cohort as compared with placebo at days 42 and 112. PGI-C Scale ranges from 'Very much improved' to 'Very much worse'
Measured: Week 6 to 16
Median percentage change in the number of countable observable seizures by subtype
Subtype (focal aware with motor component, focal impaired aware, and focal to bilateral tonic-clonic) per 28 days during the maintenance period (treatment weeks 5-16) and during the entire double blind period in the treated and placebo arms
Measured: Week 1 to 16
Percent (%) of subjects who are seizure free
by study days 29-112
Measured: Week 5 to 16
Percent (%) of subjects who are seizure free in treated arms as compared with placebo
Measured: Week 5 to 16
≥ 70% and ≥ 90% response rates in treated arms compared with placebo
during the maintenance period
Measured: Week 5 to 16
Change from visit 2 (enrollment) in the Patient weighted Quality of Life in Epilepsy (QOLIE 31-P) scale score
at days 42 and 112 in each treated arm as compared with placebo
Measured: Week 6 to 16
Number of subjects who withdraw from treatment
because of an AE in each treatment arm
Measured: Week 1 to 16
Number of adverse events (CTCAE grade 2 or higher)
in the treatment arms compared with placebo
Measured: Week 1 to 16
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
from visit 2 in each treated arm as compared with placebo at each measured timepoint
Measured: Week 1 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start27 Dec 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: insufficient funding to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizuresStudies 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
- Model description
- Double-blind, placebo-controlled, randomized at a 1:1:1 ratio to receive 20 mg of EQU-001, 60 mg of EQU-001 or a matched placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equilibre Biopharmaceuticals B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473442
- Sponsor's protocol ID
- EQU-202
- Status last verified
- Dec 2023
- First submitted
- 18 Jul 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures
- ClinicalTrials.gov ID
- NCT05473442
- Acronym / sponsor ID
- EQU-202
- Conditions
- Focal Onset Seizures
- Keywords
- EQU-001, Epilepsy, Seizures, Focal, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient funding to complete the study
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Equilibre Biopharmaceuticals B.V.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 26 Jul 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.
This study is a Phase 2 multinational, double-blind, placebo-controlled, randomized (1:1:1), efficacy and safety study of adjunctive EQU-001 for the treatment of focal onset seizures in subjects aged 18 to 65 years, who have been diagnosed with epilepsy according to International League Against Epilepsy (ILAE) Classification of the Epilepsies 2017 criteria This study is designed to test the efficacy and safety of EQU-001 20 mg and 60 mg as compared with placebo as an add-on anti-seizure medication (ASM) in subjects with uncontrolled focal onset seizures.
The treatment portion of the study will be comprised of a 4-week double-blind medication activation period and a 12-week double-blind maintenance period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, placebo-controlled, randomized at a 1:1:1 ratio to receive 20 mg of EQU-001, 60 mg of EQU-001 or a matched placebo
| Arm | Type | Receives |
|---|---|---|
| EQU-001 60 mg | Experimental | Drug: EQU-001EQU-001 60 mg (3 x 20 mg pills) |
| EQU-001 20 mg | Experimental | Drug: EQU-001, Other: Matching PlaceboEQU-001 20 mg (1 x 20 mg pill + 2 x matching placebo pills) |
| EQU-001 0 mg | Placebo comparator | Other: Matching PlaceboEQU-001 0 mg (3 x matching placebo pills) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18- 65 years at time of informed consent
- The subject or designee is willing and able to keep an accurate study diary, the subject is able to adhere to the protocol, the subject or the subject's legal representative is able read, understand, and sign informed consent, as applicable.
- Diagnosed with focal epilepsy according to ILAE (2017) criteria. Diagnosis to include clinical history and an EEG consistent with focal epilepsy. A normal interictal EEG is allowed when the clinical history is consistent with focal epilepsy.
- Subject has no seizures that are not focal by the ILAE 2017 criteria
- Subject must have 8 countable, observable focal seizures during the 8-week baseline period prior to randomization, including at least 3 in each 4-week period with no 21-day seizure-free period. These seizures must be observable (focal aware with motor component, focal impaired awareness, focal to bilateral tonic-clonic) and as such may not include focal aware seizures without a detectable motor component, aphasia, or other observable symptom.
Key exclusion criteria (26 listed)
- Pregnant or lactating
- History of hypersensitivity to ivermectin or to any of the excipients in the EQU-001 gelcap
- History of status epilepticus in the past 1 year from screening
- History of pseudo- or nonepileptic seizures, or other nonepileptic events that could be confused with epileptic seizures, within the past 5 years
- History of traumatic brain injury within 30 days prior to screening
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 |
|---|---|---|
| EQU-00120 mg pills of EQU-001 | Drug | EQU-001 20 mg, EQU-001 60 mg |
| Matching Placebo20 mg matching placebo pills | Other | EQU-001 0 mg, EQU-001 20 mg |
Primary outcome
Median percentage change in the overall number of countable observable seizures
Time frame: Every 4 weeks from week 1 up to week 16
per 28-day period relative to baseline in each treatment arm during the double-blind treatment period compared with placebo.
12 secondary outcomes
Median percentage change in the overall number of countable observable seizures
Time frame: Every 4 weeks from week 5 up to week 16
≥ 50% responder rates
Time frame: Week 1 to 16
≥ 50% responder rates
Time frame: Week 5 to 16
Difference in PGI-C Scale: Patient's Global Impression of Change (PGIC)
Time frame: Week 6 to 16
Median percentage change in the number of countable observable seizures by subtype
Time frame: Week 1 to 16
Percent (%) of subjects who are seizure free
Time frame: Week 5 to 16
Percent (%) of subjects who are seizure free in treated arms as compared with placebo
Time frame: Week 5 to 16
≥ 70% and ≥ 90% response rates in treated arms compared with placebo
Time frame: Week 5 to 16
Change from visit 2 (enrollment) in the Patient weighted Quality of Life in Epilepsy (QOLIE 31-P) scale score
Time frame: Week 6 to 16
Number of subjects who withdraw from treatment
Time frame: Week 1 to 16
Number of adverse events (CTCAE grade 2 or higher)
Time frame: Week 1 to 16
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 1 to 16
Results and safety
The study was stopped early (reason given: insufficient funding to complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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.
13 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 EQU-001 in people with Focal Onset Seizures, run by Equilibre Biopharmaceuticals B.V. at 13 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 12 inclusion and 26 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: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. 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 stopped early (reason given: insufficient funding to complete the study). Results are not available in the source record.
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?
Median percentage change in the overall number of countable observable seizures (time frame: Every 4 weeks from week 1 up to week 16). 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 21 Dec 2023.