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NCT05590676
Metformin Treatment in Infants After Perinatal Brain Injury
Phase 1 trial testing Metformin Hydrochloride in Hypoxic Ischemic Encephalopathy of Newborn in 1 participant. Terminated before completion.
22 February 2024
Quick facts
| Lead sponsor | The Hospital for Sick Children |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 2 May 2023 |
| Primary completion | 22 February 2024 |
| Estimated completion | 22 February 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Metformin Hydrochloride — full drug profile →
Conditions studied
- Hypoxic Ischemic Encephalopathy of Newborn — all drugs for Hypoxic Ischemic Encephalopathy of Newborn →
- Premature Birth — all drugs for Premature Birth →
Sponsor
The Hospital for Sick Children
Who can join
Under 3 Months, any sex, with Hypoxic Ischemic Encephalopathy of Newborn or Premature Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653 -
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 -
Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?
Gebala P, Janowska J, Sypecka J. · · 2025 · PMID 41155490 · DOI 10.3390/ijms262010200
Verify or expand the search:
- PubMed search for NCT05590676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin Hydrochloride
Trials testing the same drug.
- NCT07380841 — Metformin vs Inositol vs Diet vs Combination Therapy in PCOS · NA · completed
- NCT06899061 — Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saru · Phase 1 · active not recruiting
- NCT06920056 — A Study of BGM0504 in Overweight or Obese Participants · Phase 1 · completed
- NCT06638671 — Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity · Phase 4 · recruiting
- NCT05828303 — A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastat · Phase 1 · withdrawn
Other recruiting trials for Hypoxic Ischemic Encephalopathy of Newborn
Currently open trials in the same condition.
- NCT06762795 — The HIEnome Study: Genome Sequencing for Perinatal HIE · NA · recruiting
- NCT06747260 — Feasibility and Safety of Intranasally Administered Breast Milk in HIE · EARLY_PHASE1 · recruiting
- NCT06563687 — Continuous Glucose Monitoring in HIE · NA · recruiting
- NCT06522581 — Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy · Phase 1 · recruiting
Other The Hospital for Sick Children trials
Trials by the same sponsor.
- NCT07454681 — MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . · not yet recruiting
- NCT07452575 — 3D Ultrasound in Hemophilic Ankles · NA · not yet recruiting
- NCT07508826 — AI-assisted Endotracheal Intubation · NA · not yet recruiting
- NCT07345819 — Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis · NA · not yet recruiting
- NCT07497178 — MRgFUS for Childhood Epilepsy · 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 NCT05590676 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 The Hospital for Sick Children
- Last refreshed: 7 March 2024
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/NCT05590676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing