Open-label Extension to Protocol 1042-0600
An Open-label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
2 other identifiers
interventional
123
1 country
25
Brief Summary
To allow open-label extension to patients who have completed Protocol 1042-0600.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 3, 2007
CompletedFirst Posted
Study publicly available on registry
August 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
January 17, 2023
CompletedJanuary 17, 2023
December 1, 2022
2.5 years
August 3, 2007
May 26, 2022
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117
Percent Change in weekly seizure frequency by treatment group compared to Baseline at the beginning of the double-blind study 1042-0600 is presented. Weekly seizure frequency included partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS) during Weeks 1 through Week 117. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Baseline (Day 0) and Week 1 through Week 117
Secondary Outcomes (4)
Number of Responders During Weeks 1 Through 117
Baseline (Day 0) and Week 1 through Week 117
Number of Seizure-free Days During Weeks 1 Through 117
Week 1 through Week 117
Number of Seizure-free Participants
Day 1 through Day 224 (Week 32)
Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire
Baseline (Day 0) and up to Week 104
Study Arms (1)
ganaxolone
EXPERIMENTALactive experimental drug
Interventions
Eligibility Criteria
You may qualify if:
- Participants who have completed all scheduled clinical study visits in the previous protocol 1042-0600 and have been deemed eligible (no major adverse events thought to be drug related) by the Investigator.
- Diagnosis of epilepsy with CPS with or without secondarily generalized seizures according to the International League Against Epilepsy \[ILAE\] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and computerized tomography (CT) or magnetic resonance imaging (MRI) of the brain to rule out progressive structural lesions and electroencephalogram (EEG) or video EEG with results consistent with partial-onset epilepsy.
- 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) without 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 diary throughout the course of the study.
- Sexually active women of childbearing potential must be using a medically acceptable method of birth control and have a negative qualitative serum beta-human chorionic growth hormone (beta HCG) pregnancy test result from a blood 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 (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable form of birth control and qualitative serum βHCG pregnancy tests must be tested per protocol.
- Participants with a history of depression must be stable and may be taking one antidepressant medication
You may not qualify if:
- 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, neoplasm, 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 in 1042-0600 study.
- Clinically unstable psychiatric disorder within the last 2 years.
- Suicide attempt within the last 5 years or current significant suicidal ideation.
- History of psychosis within the last 5 years.
- 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 participant 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 women of childbearing potential (WCBP) who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a serum pregnancy test.
- A history of chronic noncompliance with drug regimens.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama
Birmingham, Alabama, 35294-0021, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Arkansas Epilepsy Program
Little Rock, Arkansas, 72205, United States
University of Southern California Adult Comprehensive Epilepsy Center
Los Angeles, California, 90033, United States
University of California-Davis
Sacramento, California, 95817, United States
Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital
Aurora, Colorado, 80010-0045, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida McKnight Brain Institute
Gainesville, Florida, 32610-0236, United States
Intercoastal Neurology
Sarasota, Florida, 34232, United States
Emory HealthCare
Atlanta, Georgia, 30322, United States
Southern Illinois University Medical Center
Springfield, Illinois, 62702, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky, Dept. of Neurology
Lexington, Kentucky, 40536, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
2799 West Grand blvd. CFP 071
Detroit, Michigan, 48202, United States
Minnesota Epilepsy Group, PA
Saint Paul, Minnesota, 55102-2383, United States
Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, 63017, United States
Neurosciences Institute at Albany Medical Center
Albany, New York, 12208, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riddle Health Care Center for Neuroscience
Media, Pennsylvania, 19063, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Neurological Clinic of Texas, P.A.
Dallas, Texas, 75230, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marinus Clinical Trials Submission Manager
- Organization
- Marinus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2007
First Posted
August 7, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2009
Study Completion
September 1, 2013
Last Updated
January 17, 2023
Results First Posted
January 17, 2023
Record last verified: 2022-12