Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
Public ClinicalTrials.gov record NCT01405053. 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 Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.
Study identification
- NCT ID
- NCT01405053
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 3 Years
- 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
- Jun 16, 2011 (Actual)
- Primary completion
- Nov 2, 2015 (Actual)
- Completion
- Nov 2, 2015 (Actual)
- Last update posted
- Aug 6, 2019
2011 – 2015
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | San Diego | California | 92123 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Gulf Breeze | Florida | 32561 | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Tampa | Florida | 33609 | — |
| Not listed | Wellington | Florida | 33414 | — |
| Not listed | Augusta | Georgia | 30912 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Lexington | Kentucky | 40536 | — |
| Not listed | Shreveport | Louisiana | 71103 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Gibbsboro | New Jersey | 08026 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Akson | Ohio | 44308 | — |
| Not listed | Columbus | Ohio | 43205 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Pittsburgh | Pennsylvania | 15224 | — |
| Not listed | Austin | Texas | 78723 | — |
| Not listed | San Antonio | Texas | 78258 | — |
| Not listed | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01405053, 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 Aug 6, 2019 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01405053 live on ClinicalTrials.gov.