Spironolactone Improved Children With Gene Mutations Related to NCOR

Plain-language summary

This study examines the effect of the drug Spironolactone in autistic children who carry NCOR-related gene mutations. Children aged 3-10 with an ADOS-2 diagnosis of autism and an NCOR-related mutation detected by whole-exome testing may take part. It is a Phase 2/Phase 3 study that is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE2/PHASE3

Status

Recruiting

Sponsor

Qilu Hospital of Shandong University

Intervention

.spironolactone

Start date

10/30/2024

Estimated completion

12/30/2027

Countries

China

Related genes

Locations

• Jinan, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.