Autism spectrum disorder, a neurodevelopmental disorder with onset in childhood. The disorder implies deficits in social and communicative abilities and restricted interests and behaviors. Many children with autism also have other coexisting disorders, such as intellectual disability.
Conditions
Interventions
Sponsors
Gillberg Neuropsychiatry Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 4-12 years of age with autism of at least moderate level, diagnosed according to DSM-IV-TR or DSM-5. The children may have coexisting moderate or severe intellectual disability and/or coexisting epilepsy. Any identified etiology of autism is allowed. 2. Age 4-12 years 3. Ability to comply with the treatment, blood sampling and scheduled follow-up visits and examinations and normal pre-treatment blood tests and ECG. 4. Written informed consent from parents (and assent for children, those with an age above 6 years) Are the trial subjects under 18? yes Number of subjects for this age range: 30 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. Clinical evidence of any significant acute or chronic disease that, in the opinion of the Investigator, may interfere with successful completion of the trial or place the subject at undue medical risk. 2. Diabetes mellitus type 1 is an example of an exclusion criteria. 3. The subject has Screening Visit values of aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT)or creatinine not within the normal reference values for children. 4. The subject has not a normal QT-interval measured on ECG. 5. The subject/caregiver is unwilling to comply with any aspect of the protocol, including blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyse the effect of Bumetanide on social and communicative abilities in children with autism spectrum disorder.;Secondary Objective: To test the safety and tolerability of the drug in children with autism spectrum disorder.;Primary end point(s): Our primary outcome measure is the PASS scale (PArental Satisfaction Survey), filled in by parents after 3 months and after 6 months. Comparisons between treated and untreated patients. ;Timepoint(s) of evaluation of this end point: After 3 months and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ratings by teachers according to the PASS scale (PArental Satisfaction Survey) Parental ratings according to PASS, other than primary evaluations The investigators assessment of CGI-S and CGI-I (Clinical Global Impression- Severity and Clinical Global Impression-Improvement) The ABAS-questionnaire (Adaptive Behavior Assessment Scale);Timepoint(s) of evaluation of this end point: Ratings by teachers according to the PASS scale after 3 and 6 months The investigators assessment of CGI-S and CGI-I (Clinical Global Impression- Severity and Clinical Global Impression- Improvement) at baseline (CGI-S) and CGI-S and CGI-I after 3, 6, and 9 months ABAS-questionnaire at baseline and at 9 months follow-up Parental ratings according to PASS at 6 and 9 months (within groups) | — |
Countries
Sweden
Contacts
Public ContactGNC
Gillberg Neuropsychiatry Centre
Outcome results
None listed