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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01002820
Other study ID # 1042-0602
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2009
Est. completion date August 2013

Study information

Verified date May 2022
Source Marinus Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 2013
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Albany Medical Center, Dept of Neurology Albany New York
United States Ohio State University Columbus Ohio
United States University of Kentucky, Dept of Neurology Lexington Kentucky
United States University of Southern California, Dept of Neurology Los Angeles California
United States Riddle Health Care Center II Philadelphia Pennsylvania
United States Thomas Jefferson University, Comprehensive Epilepsy Center Philadelphia Pennsylvania
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Marinus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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