A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
Public ClinicalTrials.gov record NCT01713946. 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 Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset Seizures
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\].
Study identification
- NCT ID
- NCT01713946
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 366 participants
Conditions and interventions
Interventions
- RAD001 Drug
- Placebo Drug
- Antiepileptic drug (1 to 3 only) Drug
- open label RAD001 (only used for post-extension phase) Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 65 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
- Apr 29, 2013 (Actual)
- Primary completion
- Oct 25, 2017 (Actual)
- Completion
- Oct 25, 2017 (Actual)
- Last update posted
- Nov 7, 2018
2013 – 2017
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham SC | Birmingham | Alabama | 35294 | — |
| TGen/APNNA | Phoenix | Arizona | 85012 | — |
| University of California at Los Angeles SC | Los Angeles | California | 90095 | — |
| Children's Hospital Oakland SC | Oakland | California | 94609 | — |
| Children's Hospital of Orange County SC | Orange | California | 92868-3874 | — |
| Rady Children's Hospital SC | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Childrens Medical Center SC | Hartford | Connecticut | 06106 | — |
| University of Chicago SC - 2 | Chicago | Illinois | 60637 | — |
| Kennedy Krieger Institute SC | Baltimore | Maryland | 21205 | — |
| Children's Hospital Boston SC | Boston | Massachusetts | 02115 | — |
| Minnesota Epilepsy Group - PA SC | Saint Paul | Minnesota | 55102-2383 | — |
| Washington University School of Medicine SC-2 | St Louis | Missouri | 63110 | — |
| Morristown Memorial Hospital SC-2 | Morristown | New Jersey | 07962 | — |
| New York University Medical Center SC-3 | New York | New York | 10016 | — |
| Cincinnati Children's Hospital Medical Center SC | Cincinnati | Ohio | 45229-3039 | — |
| Oregon Health and Science University SC - 3 | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia SC | Philadelphia | Pennsylvania | 19104-4399 | — |
| LeBonheur Childrens Medical Group SC | Memphis | Tennessee | 38103 | — |
| Texas Scottish Rite Hospital for Children Texas Scottish | Dallas | Texas | 75219 | — |
| Texas Children s Hospital SC | Houston | Texas | 77030 | — |
| The University of Texas Medical School-Houston SC | Houston | Texas | 77030 | — |
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 82 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01713946, 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 Nov 7, 2018 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01713946 live on ClinicalTrials.gov.