A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

NCT01002820 | Completed Phase 2 Results

• 1 other identifier: 1042-0602
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 7

Brief Summary

This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.

Conditions

Epilepsy, Complex Partial

Keywords

Epileptic Seizures; Seizure Disorder; Seizures; Convulsions; Anticonvulsant; Anticonvulsive; Antiepileptic; Ganaxolone

Outcome Measures

Primary Outcomes (1)

• Investigators Global Assessment

  Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.

  Screening through 52 weeks

Study Arms (1)

participants

EXPERIMENTAL

all subjects participating in 0602 are receiving ganaxolone for seizure control

Drug: ganaxolone

Interventions

ganaxolone DRUG

liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year

Also known as: CCD 1042, CAS 383-98323-2, 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one

participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
• having had no major adverse events thought to be drug related
• deriving benefit from ganaxolone treatment
• be properly informed of the nature and risks of the study and give written informed consent prior to study entry
• must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test

You may not qualify if:

• significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
• unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
• history of chronic non-compliance with drug regimens
• females currently breastfeeding
• AST or ALT levels greater than 3 times the upper limit of normal at screen
• Inability to withhold grapefruit or grapefruit products during the study

Sponsors & Collaborators

• Marinus Pharmaceuticals: lead

Study Sites (7)

University of Southern California, Dept of Neurology

Los Angeles, California, 90033, United States

Location

University of Kentucky, Dept of Neurology

Lexington, Kentucky, 40536, United States

Location

Albany Medical Center, Dept of Neurology

Albany, New York, 12208, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Riddle Health Care Center II

Philadelphia, Pennsylvania, 19063, United States

Location

Thomas Jefferson University, Comprehensive Epilepsy Center

Philadelphia, Pennsylvania, 19107, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Epilepsy, Complex Partial; Seizures; Epilepsy

Interventions

ganaxolone

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Efficacy measurements were not collected in this study. The investigator's global impression was recorded to justify continued ganaxolone treatment.

Results Point of Contact

• Title: Marinus Clinical Trials Submission Manager
• Organization: Marinus Pharmaceuticals, Inc.

clinicaltrials@marinuspharma.com

484-801-4670

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: October 16, 2009
• First Posted: October 27, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2013
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-05

Locations

US (7)