A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
Public ClinicalTrials.gov record NCT00441896. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.
Study identification
- NCT ID
- NCT00441896
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
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
- Jan 2007 (Type not available)
- Primary completion
- May 2008 (Actual)
- Completion
- May 2008 (Actual)
- Last update posted
- Jun 2, 2023
2007 – 2008
United States locations
- U.S. sites
- 15
- 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 Care Center of Northwest Florida | Pensacola | Florida | 32504 | — |
| Child Neurology Center of Northwest Florida | Pensacola | Florida | — | — |
| 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 System | 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 NCT00441896, 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 Jun 2, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00441896 live on ClinicalTrials.gov.