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Study of EQU-001 for Uncontrolled Focal Onset Seizures

Primary Purpose

Focal Onset Seizures

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EQU-001
Matching Placebo
Sponsored by
Equilibre Biopharmaceuticals B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Onset Seizures focused on measuring EQU-001, Epilepsy, Seizures, Focal, Phase II

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18- 65 years at time of informed consent
  2. 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.
  3. 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.
  4. Subject has no seizures that are not focal by the ILAE 2017 criteria
  5. 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.
  6. 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.
  7. Seizures uncontrolled after an adequate trial of at least 1 ASM within the last 2 years.
  8. 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.
  9. 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.
  10. Females of childbearing potential who are not sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study, and then for 14 days following the last dose, must agree to use acceptable birth control methods:

Exclusion Criteria:

  1. Pregnant or lactating
  2. History of hypersensitivity to ivermectin or to any of the excipients in the EQU-001 gelcap
  3. History of status epilepticus in the past 1 year from screening
  4. History of pseudo- or nonepileptic seizures, or other nonepileptic events that could be confused with epileptic seizures, within the past 5 years
  5. History of traumatic brain injury within 30 days prior to screening
  6. Resective epilepsy surgery within 1 year; epilepsy-related radiosurgery within 2 years
  7. 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.
  8. 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
  9. 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
  10. History of substance use disorder, including alcohol, within the past 2 years
  11. Currently in another investigational drug study
  12. 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.
  13. 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.
  14. Currently taking retigabine/ezogabine
  15. 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
  16. Currently taking ivermectin, or has taken it within the last 4 weeks prior to visit 1
  17. Has had a COVID-19 vaccination within the past 2 weeks prior to visit 1 (allowable to rescreen or to delay randomization) 18a.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): i. CYP3A4 inducers: rifampin, lumacaftor, mitotane, enzalutamide, apalutamide, St. John's wort, glucocorticoids ii. Medications with PGP interactions: amiodarone, apalutamide, verapamil, lorlatinib, rifampin, St. John's wort 18b. 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).

ii. CYP3A4 inhibitors, including, but not limited to clarithromycin, ceritinib, idelalisib, lonafarnib, tucatinib, erythromycin, telithromycin, diltiazem, 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 iii. Additional medications that may interact with CYP3A4, PGP, or Vitamin K: fluconazole, isavuconazole, cyclosporine, imatinib, warfarin, acenocoumarol 19. 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 20. Subject is not approved for study inclusion by the Epilepsy Consortium based on the diagnostic review form 21. Any condition that, in the opinion of the investigator, may impact a subject's safety or ability to follow study procedures

Sites / Locations

  • MedStar Georgetown University HospitalRecruiting
  • University of MiamiRecruiting
  • Tampa General HospitalRecruiting
  • Consultants in Epilepsy and Neurology, PLLCRecruiting
  • Indiana University (IU)Recruiting
  • Maine Medical CenterRecruiting
  • Mid-Atlantic Epilepsy and Sleep CenterRecruiting
  • Northeast Regional Epilepsy GroupRecruiting
  • Institute of Neurology and Neurosurgery at Saint BarnabasRecruiting
  • NYU Langone HealthRecruiting
  • Sooner Clinical Research, Inc.Recruiting
  • Comprehensive Epilepsy Center at Thomas Jefferson UniversityRecruiting
  • Northwest Houston NeurologyRecruiting
  • University of VirginiaRecruiting
  • Carilion ClinicRecruiting
  • Ramban Health Care CampusRecruiting
  • Hadassah Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Chaim Sheba Medical centerRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EQU-001 60 mg

EQU-001 20 mg

EQU-001 0 mg

Arm Description

EQU-001 60 mg (3 x 20 mg pills)

EQU-001 20 mg (1 x 20 mg pill + 2 x matching placebo pills)

EQU-001 0 mg (3 x matching placebo pills)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
≥ 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
≥ 50% responder rates
In the treated arms as compared with placebo during the maintenance period alone
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'
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
Percent (%) of subjects who are seizure free
by study days 29-112
Percent (%) of subjects who are seizure free in treated arms as compared with placebo
≥ 70% and ≥ 90% response rates in treated arms compared with placebo
during the maintenance period
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
Number of subjects who withdraw from treatment
because of an AE in each treatment arm
Number of adverse events (CTCAE grade 2 or higher)
in the treatment arms compared with placebo
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
from visit 2 in each treated arm as compared with placebo at each measured timepoint

Full Information

First Posted
July 18, 2022
Last Updated
May 18, 2023
Sponsor
Equilibre Biopharmaceuticals B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05473442
Brief Title
Study of EQU-001 for Uncontrolled Focal Onset Seizures
Official Title
A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Equilibre Biopharmaceuticals B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Onset Seizures
Keywords
EQU-001, Epilepsy, Seizures, Focal, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EQU-001 60 mg
Arm Type
Experimental
Arm Description
EQU-001 60 mg (3 x 20 mg pills)
Arm Title
EQU-001 20 mg
Arm Type
Experimental
Arm Description
EQU-001 20 mg (1 x 20 mg pill + 2 x matching placebo pills)
Arm Title
EQU-001 0 mg
Arm Type
Placebo Comparator
Arm Description
EQU-001 0 mg (3 x matching placebo pills)
Intervention Type
Drug
Intervention Name(s)
EQU-001
Intervention Description
20 mg pills of EQU-001
Intervention Type
Other
Intervention Name(s)
Matching Placebo
Intervention Description
20 mg matching placebo pills
Primary Outcome Measure Information:
Title
Median percentage change in the overall number of countable observable seizures
Description
per 28-day period relative to baseline in each treatment arm during the double-blind treatment period compared with placebo.
Time Frame
Every 4 weeks from week 1 up to week 16
Secondary Outcome Measure Information:
Title
Median percentage change in the overall number of countable observable seizures
Description
per 28-day period relative to baseline in each treatment arm during the maintenance phase compared with placebo
Time Frame
Every 4 weeks from week 5 up to week 16
Title
≥ 50% responder rates
Description
In the treated arms as compared with placebo during double blind components of the study, which consist of the medication activation and maintenance period
Time Frame
Week 1 to 16
Title
≥ 50% responder rates
Description
In the treated arms as compared with placebo during the maintenance period alone
Time Frame
Week 5 to 16
Title
Difference in PGI-C Scale: Patient's Global Impression of Change (PGIC)
Description
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'
Time Frame
Week 6 to 16
Title
Median percentage change in the number of countable observable seizures by subtype
Description
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
Time Frame
Week 1 to 16
Title
Percent (%) of subjects who are seizure free
Description
by study days 29-112
Time Frame
Week 5 to 16
Title
Percent (%) of subjects who are seizure free in treated arms as compared with placebo
Time Frame
Week 5 to 16
Title
≥ 70% and ≥ 90% response rates in treated arms compared with placebo
Description
during the maintenance period
Time Frame
Week 5 to 16
Title
Change from visit 2 (enrollment) in the Patient weighted Quality of Life in Epilepsy (QOLIE 31-P) scale score
Description
at days 42 and 112 in each treated arm as compared with placebo
Time Frame
Week 6 to 16
Title
Number of subjects who withdraw from treatment
Description
because of an AE in each treatment arm
Time Frame
Week 1 to 16
Title
Number of adverse events (CTCAE grade 2 or higher)
Description
in the treatment arms compared with placebo
Time Frame
Week 1 to 16
Title
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
from visit 2 in each treated arm as compared with placebo at each measured timepoint
Time Frame
Week 1 to 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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: i. 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. Exclusion Criteria: 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 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): i. CYP3A4 inducers: rifampin, lumacaftor, mitotane, enzalutamide, apalutamide, St. John's wort, glucocorticoids ii. 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): i. 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 ii. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-El Mandel-Portnoy, PhD MSc
Phone
(332) 400-0300
Email
clinicaltrials@eqneuro.com
Facility Information:
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Tirol
Phone
703-852-8588
Email
francis.a.tirol@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Francis Tirol
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamil Detyniecki
Phone
305-243-5944
Email
kamil.detyniecki@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Kamil Detyniecki
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selim Benbadis
Phone
813-259-0892
Email
sbenbadi@usf.edu
First Name & Middle Initial & Last Name & Degree
Selim Benbadis
Facility Name
Consultants in Epilepsy and Neurology, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Wechsler
Facility Name
Indiana University (IU)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam O'Dea
Phone
317-963-7378
Email
pkodea@iu.edu
First Name & Middle Initial & Last Name & Degree
Pam O'Dea
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Henninger
Phone
207-883-1414
Email
Heidi.Henninger@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Heidi Henninger
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Klein
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asfi Rafiuddin
Facility Name
Institute of Neurology and Neurosurgery at Saint Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mangala Nadkarni
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude Steriade
Phone
646-558-0800
Email
claude.steriade@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Claude Steriade
Facility Name
Sooner Clinical Research, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Sebastian
Facility Name
Comprehensive Epilepsy Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sperling
Facility Name
Northwest Houston Neurology
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Preethi Durgam
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan B. Fountain
Phone
434-243-6281
Email
nbf2p@virginia.edu
First Name & Middle Initial & Last Name & Degree
Nathan B. Fountain
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aashit Shah
Email
akshah@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Aashit Shah
Facility Name
Ramban Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Herskowitz
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diya Doufish
Facility Name
Rabin Medical Center
City
Petah tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Benninger
Facility Name
Chaim Sheba Medical center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Maggio
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Fahoum

12. IPD Sharing Statement

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Study of EQU-001 for Uncontrolled Focal Onset Seizures

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