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NCT01963208 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

A Phase 3 study of Drug Resistant Partial Onset Seizure, sponsored by Marinus Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
405
Enrollment target
20
Study locations

NCT01963208 is a Phase 3 study of Drug Resistant Partial Onset Seizure that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 405 participants. The trial reports 20 study locations across 14 states.

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The verdict

NCT01963208, a Phase 3 study of Drug Resistant Partial Onset Seizure, has completed, sponsored by Marinus Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
405 participants
Enrollment target
20
Study locations

Study 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).

Interventions

  • DRUG Placebo
  • DRUG ganaxolone

Study Locations (20)

Alabama

  • University of Alabama Epilepsy Center - Birmingham
  • University of Alabama at Birmingham - Birmingham

Arizona

  • Xenoscience Inc. - Phoenix
  • The MORE Foundation - Sun City

California

  • Neuro-Pain Medical Center, Inc - Fresno
  • Neurological Research Institute - Santa Monica

Florida

  • Neuroscience Consulants - Miami
  • Medsol Clinical Research Center - Port Charlotte

New Jersey

  • Cooper Medical Center of Rowan University - Camden
  • Northeast Regional Epilepsy Group - Hackensack

New York

  • Five Towns Neuroscience Research - Cedarhurst
  • Northeast Regional Epilepsy Group - Middletown

Arkansas

  • Clinical Trials Inc. - Little Rock

Colorado

  • University of Colorado- Anschutz Outpatient Pavilion - Aurora

Trial Details

FieldValue
Enrollment Target 405 participants
Start Date 2013-10
Est. Completion 2016-10
Phase Phase 3

Sponsor

Marinus Pharmaceuticals

19 total trials

What the Registry Record Tells You About NCT01963208

The ClinicalTrials.gov registry entry for NCT01963208 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 405 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marinus Pharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Drug Resistant Partial Onset Seizure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01963208 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Alabama, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01963208 about?

NCT01963208 is a clinical study titled "Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension". 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).

What is the current status of trial NCT01963208?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2013-10. Estimated completion is 2016-10.

What conditions does trial NCT01963208 study?

This clinical trial studies the following conditions: Drug Resistant Partial Onset Seizure.

What interventions are being tested in trial NCT01963208?

The interventions under investigation include: Placebo (DRUG), ganaxolone (DRUG).

Who is sponsoring clinical trial NCT01963208?

This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01963208 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.