Last reviewed · How we verify
NCT05120505
Metformin in Children With Fragile X Syndrome
Phase 4 trial testing Metformin in Fragile X Syndrome in 20 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 29 December 2021 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Placebo
Conditions studied
- Fragile X Syndrome — all drugs for Fragile X Syndrome →
- Metformin — all drugs for Metformin →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 2 to 16, any sex, with Fragile X Syndrome or Metformin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neurodevelopment and early pharmacological interventions in Fragile X Syndrome.
Milla LA, Corral L, Rivera J, Zuñiga N, et al · · 2023 · cited 9× · PMID 37599992 · DOI 10.3389/fnins.2023.1213410 -
Diverse Applications of the Anti-Diabetic Drug Metformin in Treating Human Disease.
Roberts CT, Raabe N, Wiegand L, Kadar Shahib A, et al · · 2024 · cited 8× · PMID 39770443 · DOI 10.3390/ph17121601 -
Metformin Repurposing in Neurological Disorders: A Clinical Trial Landscape.
R Y, Sharma S, C M, Rangari GM, et al · · 2026 · PMID 41930282 · DOI 10.1177/09727531261421807 -
Effects of Metformin on children with Fragile X Syndrome: a randomized, double-blind, placebo-controlled trial.
Zhu Y, Li D, Hu C, Tian Y, et al · · 2025 · PMID 41291951 · DOI 10.1186/s13229-025-00691-z -
From Discovery to Innovative Translational Approaches in 80 Years of Fragile X Syndrome Research.
van der Lei MB, Kooy RF. · · 2025 · PMID 40299377 · DOI 10.3390/biomedicines13040805
Verify or expand the search:
- PubMed search for NCT05120505
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin
Trials testing the same drug.
- NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
- NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
- NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
- NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting
Other recruiting trials for Fragile X Syndrome
Currently open trials in the same condition.
- NCT06279858 — Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome · NA · recruiting
- NCT06088589 — Speech-in-noise Perception in Autism and Fragile X · NA · recruiting
- NCT06227780 — Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders · NA · recruiting
- NCT05367960 — An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome · Phase 3 · active not recruiting
- NCT06560242 — Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant · NA · recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
- NCT04955821 — Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS · not yet recruiting
- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05120505 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05120505.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing