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NCT01713946 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT01713946: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01713946 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01713946, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
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 \[from end of Extension phase to end of study\].
Primary Outcome
Comparison of response rates in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. Response means at least a 50% reduction from baseline in partial-onset seizure frequency during the maintenance period of the core phase.
Interventions
- DRUG Placebo
- DRUG RAD001
- DRUG Antiepileptic drug (1 to 3 only)
- DRUG open label RAD001 (only used for post-extension phase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2013-04-29 |
| Est. Completion | 2017-10-25 |
| Phase | Phase 3 |
What the finished NCT01713946 record still lists
NCT01713946 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01713946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01713946 about?
NCT01713946 is a clinical study titled "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". 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 r...
What is the current status of trial NCT01713946?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2013-04-29. Estimated completion is 2017-10-25.
What interventions are being tested in trial NCT01713946?
The interventions under investigation include: Placebo (DRUG), RAD001 (DRUG), Antiepileptic drug (1 to 3 only) (DRUG), open label RAD001 (only used for post-extension phase) (DRUG).
Who is sponsoring clinical trial NCT01713946?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01713946's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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