NCT03156153

Brief Summary

The investigators are going to carry out a randomized double-blind placebo-controlled trial to study the efficiency and mechanism of bumetanide on the treatment of children with Autism Spectrum Disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

March 1, 2021

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

May 15, 2017

Last Update Submit

February 25, 2021

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Childhood Autism Rating Scale(CARS)

    CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder

    Day 0 and Day 90

Secondary Outcomes (6)

  • Clinical Global Impressions Scale (CGI)

    Day 0 and Day 90

  • Social Responsiveness Scale (SRS)

    Day 0 and Day 90

  • Autism Diagnostic Observation Schedule (ADOS)

    Day 0 and Day 90

  • Short Sensory Profile Report

    Day 0 and Day 90

  • Symbolic Play Test

    Day 0 and Day 90

  • +1 more secondary outcomes

Other Outcomes (4)

  • MRI Structure Imaging and Spectrum imaging, data analysis

    Day 0 and Day 90

  • Multichannel EEG Signals

    Day 0 and Day 90

  • Genome wide association study from blood sample

    Day 90

  • +1 more other outcomes

Study Arms (2)

Bumetanide group

EXPERIMENTAL

Double-blind phase: in the first 3 months, patients will receive the experimental treatment - bumetanide, oral intake, 0.5mg/time, twice a day; Open-label phase: after 3 month double-blined treatment, all the patients will receive 3-month bumetanide treatment - oral intake, 0.5mg/time, twice a day.

Drug: Bumetanide

Control group

PLACEBO COMPARATOR

Double-blind phase: in the first 3 months, patients will receive the placebo - oral intake, 0.5mg/time, twice a day; Open-label phase: after 3 month double-blined treatment, patients in this group will receive 3-month bumetanide treatment - oral intake, 0.5mg/time, twice a day.

Drug: Placebo

Interventions

BumetanideDRUG

bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm

Bumetanide group
PlaceboDRUG

placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm

Control group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The patients, aged from 3 to 6 years old, were given the diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) , by a team of autism experts; Scores for Children Autism Rating Scale (CARS) were more than 30; Signed Informed Consents were provided by parents.

You may not qualify if:

  • Liver and kidney dysfunction; With a history of allergy to sulfa drugs; abnormal ECG; chromosomal abnormality; suffering from nervous system diseases (such as epilepsy, schizophrenia, and so on); using the melatonin treatment for sleep disorders or withdrawal less than three weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Bumetanide

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic Chemicalsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Fei Li, doctor

    Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

May 24, 2017

Primary Completion

July 8, 2019

Study Completion

July 10, 2019

Last Updated

March 1, 2021

Record last verified: 2019-07

Locations

CN(1)