A Phase II dose ranging study of Bumetanide solution in children and adolescents with autism spectrum disorders.

Phase 1

• Conditions: Children and adolescents aged 2 to 18 years, corresponding to F84.0 (Childhood Autism) or F84.5 (Asperger's Syndrome) according to the International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10) and with a Childhood Autism Rating Scale (CARS) score > 34.; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2013-003259-39-FR
• Lead Sponsor: eurochlore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female patients aged 2 to 18 years, inclusive;
2.F84.0 (Childhood Autism) or F84.5 (Asperger's Syndrome) scores according to the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10);
3.Patients meeting criteria for autism on Autism Diagnosis Interview-Revised (ADI-R).
4.CARS score > 34 points;
5.The patient is able to comply with the protocol for the duration of the study, including treatment, blood sampling and scheduled follow-up visits and examinations;
6.The patient's parent/guardian has given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (QT interval lengthening), endocrinologic, immunologic, or hematologic disease;
2.Renal or hepatic dysfunction that would interfere with excretion or metabolism of Bumetanide;
3.Patients with any specific neurological disorders like seizures, microcephaly;
4.Patients taking psychoactive medications except melatonin;
5.Documented history of hypersensitivity reaction to sulfonamide derivatives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified