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Terminated Phase 2 Interventional Results available

Open-label Extension to Protocol 1042-0500

ClinicalTrials.gov ID: NCT00442104

Public ClinicalTrials.gov record NCT00442104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms.

Study identification

NCT ID
NCT00442104
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Marinus Pharmaceuticals
Industry
Enrollment
54 participants

Conditions and interventions

Interventions

  • Ganaxolone Drug

Drug

Eligibility (public fields only)

Age range
4 Months to 24 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2006
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009
Last update posted
May 27, 2024

2007 – 2009

United States locations

U.S. sites
14
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Children's Hospital of Los Angeles Los Angeles California 90027
Mattel Children's Hospital at UCLA Los Angeles California 90095
Children's National Medical Center Washington D.C. District of Columbia 20010
Miami Children's Hospital, The Brain Institute Miami Florida 33155
Child Neurology Center of Nrothwest Florida, P.A. Pensacola Florida 32504
University of Chicago Comer Children's Hospital Chicago Illinois 60637
Minnesota Epilepsy Group, P.A. Saint Paul Minnesota 55102
Montefiore Medical Center- Albert Einstein College of Medicine The Bronx New York 10467
Le Bonheur Children's Medical Center Memphis Tennessee 38105
Dallas Pediatric Neurology Associates Dallas Texas 75230
Texas Children's Hospital Houston Texas 77030
Virginia Commonwealth University Health Systems Richmond Virginia 23298
Children's Hospital and Regional Medical Center Seattle Washington 98105
Children's Hospital of Wisconsin Milwaukee Wisconsin 53201

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00442104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 27, 2024 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00442104 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →