129
Participants
Start Date
October 26, 2016
Primary Completion Date
August 6, 2019
Study Completion Date
May 4, 2020
Sarizotan low dose
2 mg or 5 mg bid based on age and weight criteria for 24 wks DB 2 mg bid (4 to \<13 years; ≥13 years of age and weighing \<25 kg; 5 mg bid (≥13 years of age and weighing ≥25 kg). Assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients.
Sarizotan high dose
5 mg or 10 mg bid based on age and weight criteria for 24 wks DB 5 mg bid (4 to \<13 years; ≥13 years of age and weighing \<25 kg; 10 mg bid (≥13 years of age and weighing ≥25 kg) Assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients
Placebo
Placebo BID followed by assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients.
South Metropolitan Health Service Fiona Stanley Hospital, Murdoch
U.O. Neuropsichiatria Infantile, Milan
University of Alabama, Birmingham
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena
Gillette Children's Specialty Healthcare, Saint Paul
Rush University Medical Center, Chicago
Baylor College of Medicine, Houston
University of California, San Diego
Amrita Institute of Medical Sciences, Kochi
Vijaya Health Centre, Chennai
P.D. Hinduja National Hospital and Medical Research Centre, Mumbai
Jaslok Hospital and Research centre, Mumbai
All India Institute of Medical Sciences, New Delhi
King's College Hospital, London
Lead Sponsor
Newron Pharmaceuticals SPA
INDUSTRY