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NCT02758626 · ClinicalTrials.gov registry record · Phase 2
Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02758626 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants.
The verdict
NCT02758626, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment period. Treatment Period 1 will be followed by a 4-week Washout Period. Based on ataluren PK and pharmacodynamic data, the 4-week washout period is deemed an appropriate length of time to eliminate any ataluren drug effects. Following the Washout Period, patients will crossover to receive the opposite treatment during Treatment Period 2 as follows: Patients receiving ataluren during Treatment Period 1 will receive placebo during Treatment Period 2. Patients receiving placebo during Treatment Period 1 will receive ataluren during Treatment Period 2.
Interventions
- DRUG Placebo
- DRUG ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-11 |
| Est. Completion | 2021-02-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02758626
The ClinicalTrials.gov registry entry for NCT02758626 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02758626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02758626 about?
NCT02758626 is a clinical study titled "Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome". This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant epilepsy. Patients will receive 12 weeks of ataluren or placebo during each treatment period. Treatment Period 1 wil...
What is the current status of trial NCT02758626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2016-11. Estimated completion is 2021-02-27.
What interventions are being tested in trial NCT02758626?
The interventions under investigation include: Placebo (DRUG), ataluren (DRUG).
Who is sponsoring clinical trial NCT02758626?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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