Spironolactone in Children with NCOR Gene Mutations and ASD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates spironolactone as a potential treatment for neurodevelopmental symptoms linked to NCOR gene mutations in children with autism. Eligible participants are 3-10 years old and must meet ADOS-2 criteria for autism and have a confirmed NCOR-related mutation. The trial will monitor safety and clinical outcomes through collection of clinical data and biological samples, while participants or their guardians provide informed consent. Exclusion criteria include other pathogenic mutations, hyperkalemia risk, renal impairment, recent spironolactone use, and certain concomitant medications. The study is led by Qilu Hospital of Shandong University in Jinan, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ADOS-2 diagnostic criteria for autistic children
2. Patients with NCOR related gene mutation detected by whole exon test;
3. Age: 3-10 years old;
4. The subject and (or) guardian sign the informed consent, agreeing that the researcher will cooperate with the clinical trial process and collect clinical data and peripheral blood and urine samples;

Exclusion Criteria:

1. have other pathogenic mutations (confidence higher than the NCOR related mutation);
2. Boys over 10 years old;
3. Allergic to spironolactone, used spironolactone one month before enrollment;
4. Hyperkalemia, serum potassium concentration \> 5.5mmol/L;
5. Renal insufficiency;
6. Used related drugs one month before enrollment: potassium supplement, angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, digoxin, coletenamine, acetylsalicylic acid, abiraterone;
7. Fever (body temperature above 37.3°);
8. Clinically significant metabolic, hematological, liver, immune, urological, endocrine, neurological, pulmonary, psychiatric, skin, allergic, renal, or other major conditions in the determination of ASD that may affect the interpretation of study findings or patient safety.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Cao Aihua Qilu Hospital of Shandong University
• Email: qlyyebk@163.com
• Phone: 18560086317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.