Last reviewed · How we verify
NCT06199700
Esketamine for the Treatment of Rett Syndrome
EARLY_PHASE1 trial testing Esketamine hydrochloride in Rett Syndrome in 3 participants. Participants enrolled and being followed up; not accepting new ones.
4 April 2024
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 15 November 2023 |
| Primary completion | 4 April 2024 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Esketamine hydrochloride — full drug profile →
Conditions studied
- Rett Syndrome — all drugs for Rett Syndrome →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 5 to 10, female only, with Rett Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional study is to learn about the efficacy and safety of Esketamine for treating children with Rett syndrome (RTT). The main questions it aims to answer are: * whether Esketamine treatment is effective in improving symptom severity for RTT. * whether Esketamine is safe in the treatment of RTT. Participants will receive a weekly intravenous infusion of Esketamine for five weeks and will be assessed for disease severity and drug safety.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intravenous esketamine in pediatric Rett syndrome: An open-label, early phase 1 pilot study
Li H, Liu S, Lin C, Wu Y, et al · · 2025
Verify or expand the search:
- PubMed search for NCT06199700
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Rett Syndrome
Currently open trials in the same condition.
- NCT06840496 — To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome · Phase 3 · recruiting
- NCT07151950 — Obi Medical Robot: Evaluating Effectiveness Related to Usability · active not recruiting
- NCT06856759 — Single-Dose AAV-MECP2 Safety/Tolerability and Efficacy in Rett Syndrome · EARLY_PHASE1 · recruiting
- NCT07418905 — Technology-supported Motor Rehabilitation for People With Rett Syndrome · NA · active not recruiting
- NCT06152237 — Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study) · Phase 1, PHASE2 · active not 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 NCT06199700 (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/NCT06199700.
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