A Randomised, Double-Blind, Placebo-Controlled 6-month Study to Evaluate the Efficacy, Safety, and Tolerability of Sarizotan in Patients With Rett Syndrome With Respiratory Symptoms

Trial Profile

A Randomised, Double-Blind, Placebo-Controlled 6-month Study to Evaluate the Efficacy, Safety, and Tolerability of Sarizotan in Patients With Rett Syndrome With Respiratory Symptoms

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 Jul 2018

At a glance

  • Drugs Sarizotan (Primary)
  • Indications Rett syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms STARS
  • Sponsors Newron Pharmaceuticals
  • Most Recent Events

    • 11 Jul 2018 Planned End Date changed from 1 Dec 2018 to 1 Apr 2019.
    • 11 Jul 2018 Planned primary completion date changed from 1 Jul 2018 to 1 Apr 2019.
    • 13 Jun 2018 According to a Newron Pharmaceuticals media release, The safety of the patients in the trial is overseen by an independent international safety monitoring board which has reviewed all safety data and has recommended that the study be continued without any modification.Approximately 90 percent of the patients who have completed the 24-week double-blind period have continued in the longterm open-label extension.
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