Table 5.

Trial registration data set

Data category	Information
Primary registry and trial identifying number	EudraCT database: 2020–002196-35
Date of registration in primary registry	16th November 2020
Secondary identifying numbers	NA
Source(s) of monetary or material support	Dutch National research agenda, the Netherlands
Primary sponsor	Amsterdam UMC, location VUmc
Secondary sponsor(s)	Na
Contact for public queries	H. Bruining (MD, phd) n.is.you@amsterdamumc.nl
Contact for scientific queries	H. Bruining (MD, phd) n.is.you@amsterdamumc.nl
Public title	Bumetanide for developmental disorders
Scientific title	Post trial access cohort bumetanide for developmental disorders
Countries of recruitment	Netherlands
Health condition(s) or problem(s) studied	Neurodevelopmental disorders, autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), learning disorders
Intervention(s)	Bumetanide bidaily 0.5–1.5 mg
Key inclusion and exclusion criteria	Participation in previous bumetanide trials by H. Bruining (BAMBI, BASCET, BATSCH) or Ages eligible for study: 7–17 Sexes eligible for study: both Accepts healthy volunteers: no Inclusion criteria: One of the following: 1) Above clinical cut-off scores of altered sensory reactivity on the Sensory Profile and either a clinical ASD or ADHD diagnosis based on DSM-5 (or DSM-IV) or an epilepsy diagnosis, 2) Criteria met for autism on DSM-IV or V and Social Responsiveness Scale (SRS) 3) A history of behavioral problems combined with a definite diagnosis of TSC: either meeting criteria for clinical definite TSC, or a mutation identified in the TSC1 or TSC2 gene; Exclusion criteria: 1) inability to comply with study protocol, 2) presence of severe medical or genetic disorder other than related to ASD, TSC or epilepsy, 3) renal insufficiency, 4) start of behavioral treatment during study, 5) treatment with methylphenidate, NSAIDs, aminoglycoside, digitalis, antihypertensive agents, indomethacin, probenecid, acetazolamide, lithium or other diuretics, 6) history of hypersensitivity to sulfonamide derivatives 7) body weight < 30 kg
Study type	Intervention model: open label post-trial access
	Primary purpose: treatment
	Phase II
Date of first enrolment	December 2020
Target sample size	115
Recruitment status	Recruiting
Primary outcome(s)	Set of parent proxy PROMIS questionnaires: physical stress experience, psychological stress experience, sleep disturbances, sleep-related impairment, cognitive function, anxiety, fatigue, peer relationships, life satisfaction, depressive symptoms
Key secondary outcomes	Conventional questionnaires: SRS, RBS, ABC, SP-NL
	Resting-state EEG
	Neurocognitive testing (using in-house Emma Toolbox)