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NCT02790034 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms
A Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
- Terminated
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT02790034: Clinical Trial Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
NCT02790034 is a Phase 2 study that was terminated before completion, run by Newron Pharmaceuticals SPA. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02790034, a Phase 2 study, was terminated before completion, sponsored by Newron Pharmaceuticals SPA.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues).
Primary Outcome
Measured as the percent change in the number of apnea episodes per hour during awake time, calculated using an ambulatory data acquisition system (BioRadioTM) as part of home monitoring procedure. BioRadioTM record specific respiratory and cardiac parameters.
Interventions
- DRUG Placebo
- DRUG Sarizotan low dose
- DRUG Sarizotan high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2016-10-26 |
| Est. Completion | 2020-05-04 |
| Phase | Phase 2 |
Why NCT02790034 stopped before completion
NCT02790034 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02790034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02790034 about?
NCT02790034 is a clinical study titled "Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms". This study evaluates the safety, tolerability and efficacy of Sarizotan in reducing respiratory abnormalities in Rett Syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues).
What is the current status of trial NCT02790034?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2016-10-26. Estimated completion is 2020-05-04.
What interventions are being tested in trial NCT02790034?
The interventions under investigation include: Placebo (DRUG), Sarizotan low dose (DRUG), Sarizotan high dose (DRUG).
Who is sponsoring clinical trial NCT02790034?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02790034's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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