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A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT00465517•Marinus Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 69 years

Sex

ALL

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), 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.
+5 more criteria

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.
+16 more criteria

Locations (27)

University of Alabama

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Arkansas Epilepsy Program

Little Rock, Arkansas, United States

University of Southern California Adult Comprehensive Epilepsy Center

Los Angeles, California, United States

University of California-Davis

Sacramento, California, United States

Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

University of Florida McKnight Brain Institute

Gainesville, Florida, United States

Intercoastal Medicine

Sarasota, Florida, United States

Emory HealthCare

Atlanta, Georgia, United States

Key Dates

Start Date

February 1, 2007

Primary Completion Date

October 1, 2008

Completion Date

November 1, 2008

Last Updated

March 15, 2023

Enrollment

147

ACTUAL participants

Conditions

Partial EpilepsyCatamenial Epilepsy

Interventions

Ganaxolone

DRUG

Placebo

OTHER

Surgery as a Treatment for Medically Intractable Epilepsy

NCT01273129

EpilepsyEpilepsy, Temporal Lobe+1 more

View study

COMPLETEDPHASE1

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

NCT04903314

Partial Epilepsy

View study

APPROVED_FOR_MARKETING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Surgery as a Treatment for Medically Intractable Epilepsy

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

Cenobamate Expanded Access Program (EAP)

PRX-00023 Therapy in Localization-Related Epilepsy

Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

Verapamil and Catamenial Epilepsy