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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Epilepsy, Complex Partial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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participants

all subjects participating in 0602 are receiving ganaxolone for seizure control

Group Type EXPERIMENTAL

ganaxolone

Intervention Type DRUG

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

Interventions

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ganaxolone

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No