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

NCT01002820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-09-07

Study results available
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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

Interventions

DRUG

ganaxolone

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

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002820 on ClinicalTrials.gov