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Clinical trialNCT02790034TerminatedPhase 2/PHASE3Interventional

Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms

SponsorNewron Pharmaceuticals SPAEnrollment129Rett Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • South Metropolitan Health Service Fiona Stanley Hospital

    Murdoch, Western Australia, Australia

India
  • Amrita Institute of Medical Sciences

    Kochi, Kerala, India

  • Vijaya Health Centre

    Chennai, Tamil Nadu, India

  • Jaslok Hospital and Research Centre

    Mumbai, India

  • P.D. Hinduja National Hospital and Medical Research Centre

    Mumbai, India

  • All India Institute of Medical Sciences

    New Delhi, India

Italy
  • A.O.U. Senese Policlinico Santa Maria Alle Scotte

    Siena, Tuscany, Italy

  • U.O. Neuropsichiatria Infantile

    Milan, Italy

United Kingdom
  • King'S College Hospital

    London, United Kingdom

United States
  • University of Alabama

    Birmingham, Alabama, United States

  • University of California

    San Diego, California, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Gillette Children'S Specialty Healthcare

    Saint Paul, Minnesota, United States

  • Baylor College of Medicine

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboSarizotan high doseSarizotan low dose
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Oct 2016
Primary completion
6 Aug 2019
Completion
4 May 2020
Last update posted
21 Dec 2021
Registered enrollment
129
Registry id
NCT02790034

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.