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A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

Primary Purpose

Partial Epilepsy, Catamenial Epilepsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ganaxolone
Placebo
Sponsored by
Marinus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy focused on measuring Partial onset seizures, Complex-partial seizures, Anticonvulsant, Partial seizures, Catamenial epilepsy

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy.
  • During the 8 week baseline period preceding randomization visit (Visit 4), subjects should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average.
  • Subjects should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Subjects with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.]
  • Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening.
  • Maintenance of current AEDs without a change in dosing for the duration of study.

    • Concomitant vigabatrin not permitted;
    • Felbamate is allowed if the subject has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. [Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.]
    • Subjects receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs.
  • Male or female, 18 to 69 years of age (inclusive). [Note: Subjects who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.]
  • A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities.
  • Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
  • Able to participate for the full term of study.
  • Able to keep a seizure & medication diary throughout the course of the study.
  • Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (eg, a spermicidal cream) is acceptable.in subjects who are not sexually active, abstinence is an acceptable form of birth control and serum β-HCG must be tested per protocol.
  • Subjects with a history of depression who are stable an dmay be taking 1 anti-depressant medication.

EXCLUSION CRITERIA:

  • Presence of non-motor simple partial seizures only.
  • History of pseudoseizures in the last 5 years.
  • History of a primary generalized seizure in the last 5 years.
  • Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed).
  • Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease.
  • Status epilepticus within the last year prior to randomization.
  • Clinically unstable psychiatric disorder within the last 2 years.
  • Suicidal attempt within the last 5 years or current significant suicidal ideation.
  • History of psychosis within the last 5 years. [Note: Subjects who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.]
  • Current use of neuroleptics for psychosis.
  • A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk.
  • Known sensitivity or allergy to progesterone or related steroid compounds.
  • History of drug use or alcohol abuse within the past 5 years.
  • Sexually active WCBP who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a pregnancy test.
  • Females who are currently breastfeeding.
  • history of chronic noncompliance with drug regimens.
  • Exposure to any other investigational drug or device within 30 days prior to screening.
  • Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3 times upper limits of normal (ULN) at screening.
  • Benzodiazepines may be used intermittently for the control of seizure clustering as a one time rescue up to a maximum of 4 occasions as follows:

    • Subjects who need benzodiazepines for control of seizures more than once per month or more than 4 times total during the Titration and Maintenance Phases will be discontinued.
    • Once during the Titration Phase
    • No more than once per month during the Maintenance Phase
    • Each occasion may be a period of 24 hours, during which up to 3 doses of benzodiazepine may be used.
    • If a subject is taking a benzodiazepine chronically for epilepsy and non-epilepsy conditions, it will be counted as 1 of the 3 AEDs and the dose cannot be changed during the study.
  • Subject has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
  • Inability to withhold grapefruit and grapefruit juice from diet for the entire clinical trial.

Sites / Locations

  • University of Alabama
  • Barrow Neurological Institute
  • Arkansas Epilepsy Program
  • University of Southern California Adult Comprehensive Epilepsy Center
  • University of California-Davis
  • Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital
  • Yale University School of Medicine
  • University of Florida McKnight Brain Institute
  • Intercoastal Medicine
  • Emory HealthCare
  • Southern Illinois University Medical Center
  • University of Iowa Hospitals and Clinics
  • University of Kentucky, Dept. of Neurology
  • Mid-Atlantic Epilepsy and Sleep Center
  • 2799 West Grand blvd. CFP 071
  • Minnesota Epilepsy Group, PA
  • Comprehensive Epilepsy Care Center for Children and Adults
  • Overlook Hospital and Hackensack Medical Center
  • Neurosciences Institute at Albany Medical Center
  • SUNY Upstate Medical University
  • Ohio State University Medical Center
  • Riddle Health Care Center for Neuroscience
  • Drexel University / Hahneman Hospital
  • Thomas Jefferson University
  • Vanderbilt University Medical Ctr
  • Neurological Clinic of Texas, P.A.
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ganaxolone

non-active drug

Arm Description

active study drug

placebo

Outcomes

Primary Outcome Measures

Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)] during Weeks 1 through 10.

Secondary Outcome Measures

Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including POS with or without secondary generalization, but not non-motor SPS] during the Weeks 3 through 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10
Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented.
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10
Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Responders During Weeks 1 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Number of Responders During Weeks 3 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Number of Seizure-free Participants Up to Week 2
Number of seizure-free participants is presented.
Number of Seizure-free Participants During Weeks 3 Through 10
Number of seizure-free participants is presented.
Number of Seizure-free Participants During Weeks 1 Through 10
Number of seizure-free participants is presented.
Number of Seizure-free Days Up to Week 2
Summary of Seizure-Free days is presented.
Number of Seizure-free Days During Week 3 Through 10
Summary of Seizure-Free days is presented.
Number of Seizure-free Days During Week 1 Through 10
Summary of Seizure-Free days is presented.

Full Information

First Posted
April 24, 2007
Last Updated
February 17, 2023
Sponsor
Marinus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00465517
Brief Title
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marinus Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy, Catamenial Epilepsy
Keywords
Partial onset seizures, Complex-partial seizures, Anticonvulsant, Partial seizures, Catamenial epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ganaxolone
Arm Type
Experimental
Arm Description
active study drug
Arm Title
non-active drug
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Ganaxolone
Intervention Description
Oral suspension 200-500 mg 3x/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
non-active placebo
Primary Outcome Measure Information:
Title
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
Description
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)] during Weeks 1 through 10.
Time Frame
Week 1 through Week 10
Secondary Outcome Measure Information:
Title
Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10
Description
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including POS with or without secondary generalization, but not non-motor SPS] during the Weeks 3 through 10
Time Frame
Week 3 through Week 10
Title
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Description
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and at Week 1 through Week 10
Title
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Description
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and at Week 3 through Week 10
Title
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Description
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and at Week 1 through Week 10
Title
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Description
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and at Week 3 through Week 10
Title
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10
Description
Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented.
Time Frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Title
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10
Description
Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame
Baseline and at Week 1 through Week 10
Title
Number of Responders During Weeks 1 Through 10
Description
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Time Frame
Baseline and at Week 1 through Week 10
Title
Number of Responders During Weeks 3 Through 10
Description
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Time Frame
Baseline and at Week 3 through Week 10
Title
Number of Seizure-free Participants Up to Week 2
Description
Number of seizure-free participants is presented.
Time Frame
Up to Week 2
Title
Number of Seizure-free Participants During Weeks 3 Through 10
Description
Number of seizure-free participants is presented.
Time Frame
Week 3 through Week 10
Title
Number of Seizure-free Participants During Weeks 1 Through 10
Description
Number of seizure-free participants is presented.
Time Frame
Week 1 through Week 10
Title
Number of Seizure-free Days Up to Week 2
Description
Summary of Seizure-Free days is presented.
Time Frame
Up to Week 2
Title
Number of Seizure-free Days During Week 3 Through 10
Description
Summary of Seizure-Free days is presented.
Time Frame
Week 3 through Week 10
Title
Number of Seizure-free Days During Week 1 Through 10
Description
Summary of Seizure-Free days is presented.
Time Frame
Week 1 through Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy. During the 8 week baseline period preceding randomization visit (Visit 4), participants should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average. Participants should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Participants with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.] Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening. Maintenance of current AEDs without a change in dosing for the duration of study. Concomitant vigabatrin not permitted; Felbamate is allowed if the participant has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. [Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.] Participants receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs. Male or female, 18 to 69 years of age (inclusive). [Note: Participants who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.] A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities. Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. Able to participate for the full term of study. Able to keep a seizure & medication diary throughout the course of the study. Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (eg, a spermicidal cream) is acceptable.in participants who are not sexually active, abstinence is an acceptable form of birth control and serum β-HCG must be tested per protocol. Participants with a history of depression who are stable and may be taking 1 anti-depressant medication. EXCLUSION CRITERIA: Presence of non-motor simple partial seizures only. History of pseudoseizures in the last 5 years. History of a primary generalized seizure in the last 5 years. Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed). Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease. Status epilepticus within the last year prior to randomization. Clinically unstable psychiatric disorder within the last 2 years. Suicidal attempt within the last 5 years or current significant suicidal ideation. History of psychosis within the last 5 years. [Note: Participants who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.] Current use of neuroleptics for psychosis. A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk. Known sensitivity or allergy to progesterone or related steroid compounds. History of drug use or alcohol abuse within the past 5 years. Sexually active WCBP who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a pregnancy test. Females who are currently breastfeeding. history of chronic noncompliance with drug regimens. Exposure to any other investigational drug or device within 30 days prior to screening. Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3 times upper limits of normal (ULN) at screening. Benzodiazepines may be used intermittently for the control of seizure clustering as a one time rescue up to a maximum of 4 occasions as follows: Participants who need benzodiazepines for control of seizures more than once per month or more than 4 times total during the Titration and Maintenance Phases will be discontinued. Once during the Titration Phase No more than once per month during the Maintenance Phase Each occasion may be a period of 24 hours, during which up to 3 doses of benzodiazepine may be used. If a participant is taking a benzodiazepine chronically for epilepsy and non-epilepsy conditions, it will be counted as 1 of the 3 AEDs and the dose cannot be changed during the study. Participant has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted. Inability to withhold grapefruit and grapefruit juice from diet for the entire clinical trial.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0021
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arkansas Epilepsy Program
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Southern California Adult Comprehensive Epilepsy Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010-0045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Florida McKnight Brain Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0236
Country
United States
Facility Name
Intercoastal Medicine
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Emory HealthCare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southern Illinois University Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky, Dept. of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
2799 West Grand blvd. CFP 071
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Epilepsy Group, PA
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102-2383
Country
United States
Facility Name
Comprehensive Epilepsy Care Center for Children and Adults
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Overlook Hospital and Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Neurosciences Institute at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riddle Health Care Center for Neuroscience
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Drexel University / Hahneman Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University Medical Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Neurological Clinic of Texas, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34528245
Citation
Maguire MJ, Nevitt SJ. Treatments for seizures in catamenial (menstrual-related) epilepsy. Cochrane Database Syst Rev. 2021 Sep 16;9(9):CD013225. doi: 10.1002/14651858.CD013225.pub3.
Results Reference
derived
Links:
URL
https://marinuspharma.com/
Description
information about ganaxolone

Learn more about this trial

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

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