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Home » Find Clinical Trials » Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

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Servier Protocol Code: CL3-95008-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03715153 EudraCT Number: 2017-004420-30

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 50 locations

Study description

This study was done to test if a drug called bumetanide could help children with Autism Spectrum Disorder (ASD).

ASD has many different symptoms. For example, difficulties in communication and relationships with others.

Bumetanide is a well-known drug which helps remove water, salt and chloride from the body. Too much chloride in the brain cells could affect how the brain develops and works in people with ASD. Bumetanide helps reduce the amount of chloride in the brain cells.

In a previous study, bumetanide was linked to an improvement in some of the symptoms of children with ASD. Researchers needed to confirm this in a study with a larger number of patients called a Phase 3 study.

The main goal of this Phase 3 study was to confirm if bumetanide improves ASD symptoms in children. To do this, it was compared with a placebo. A placebo looks like a medicine but does not contain any real medicine.

Official title: Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.
Results
English (USA)
English (USA)
Conditions
Autism Spectrum Disorder (ASD)
Interventions / Treatments
  • BUMETANIDE (S95008) for week 0 - 26
  • PLACEBO for week 0 - 26
  • Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Other study id numbers
  • CL3-95008-002

Eligibility Criteria

Eligible age for the study

2 years to 6 years (Child)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be a child (from 2 to under 7 years old)
  • Have moderate to severe Autism Spectrum Disorder.

 

Participants could not take part in the study if they:

  • Had any long-term liver, kidney, or heart disease.
  • Had started or stopped mental health therapy sessions that involves counselling or talking, such as psychotherapy or behavioural therapy, in the month before the study started.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: BUMETANIDE (S95008) followed by Open-Label S95008

Participants took S95008 for 6 months (26 weeks). Then, they started another 6-month treatment period with open-label S95008. This means that the participants, the parents, and the doctors knew that only bumetanide was taken.

Intervention / Treatment
Drug: BUMETANIDE (S95008) for week 0 - 26

Bumetanide oral solution of 0.5 milligrams (mg) of per millilitre (mL) taken twice daily.

Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52

Bumetanide oral solution of 0.5 milligrams (mg) of per millilitre (mL) taken twice daily.

Participant Group / Arm
Placebo Comparator: PLACEBO followed by Open-Label S95008

Participants took placebo for 6 months (26 weeks). Then, they started another 6-month treatment period with open-label S95008. This means that the participants, the parents, and the doctors knew that only bumetanide was taken.

Intervention / Treatment
Drug: PLACEBO for week 0 - 26

Oral solution Taken twice daily.

The placebo looked like bumetanide (oral solution) but did not contain any real medicine.

Drug: Open-Label BUMETANIDE (S95008) for weeks 26 - 52

Oral solution of 0.5 milligrams (mg) of bumetanide per millilitre (mL) taken twice daily.

Keywords

Additional Relevant MeSH Terms Glioma
Autism Spectrum Disorder