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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 366 participants.
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 \[from end of Extension phase to end of study\].
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01713946
The ClinicalTrials.gov registry entry for NCT01713946 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01713946 reports 0 study locations.
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.
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