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

NCT00465517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2023-03-15

Study results available
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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.

Conditions

  • Partial Epilepsy
  • Catamenial Epilepsy

Interventions

DRUG

Ganaxolone

Oral suspension 200-500 mg 3x/day

OTHER

Placebo

non-active placebo

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-10-31
Completion
2008-11-30

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 NCT00465517 on ClinicalTrials.gov