Diseases and Related Health Problems, tenth revision (ICD-10) and with a Childhood Autism Rating Scale (CARS) score > 34.
Conditions
Interventions
Product Name: Bumetanide
Pharmaceutical Form: Oral solution
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: BUMETANIDE
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Neurochlore
Eligibility
Sex/Gender
All
Inclusion criteria
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.Weight =11 kg; 6. 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; 7.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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal dose strength for the pivotal Phase III study;Secondary Objective: To evaluate the pharmacokinetics (PK) of Bumetanide in children and adolescents with ASD; To confirm the efficacy of Bumetanide in the treatment of children and adolescents with autistic spectrum Disorder (ASD). ;Primary end point(s): Change in CARS from baseline (Day 1) to Day 90. The treatment groups will be compared using a non-parametric test as specified in the Statistical Analysis Plan. ;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): By way of further confirmatory measures of efficacy, the following endpoints will be analyzed: - CGI-I scale; - The Vineland Adaptive Behavior Scales (Vineland-II) (personal and social skills); - The Social Responsiveness Scale (SRS) (focuses on the child?s reciprocal social interactions); - QOL ;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
France, Spain
Contacts
Public ContactClinical Trial Department
Neurochlore
Outcome results
None listed