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NCT03434366
Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
Phase 2 trial testing ketamine and dexmedetomidine in Autism Spectrum Disorder in 50 participants. Suspended.
30 December 2023
Quick facts
| Lead sponsor | Guangzhou Women and Children's Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 20 January 2018 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- ketamine and dexmedetomidine — full drug profile →
- ketamine (ketamine) — full drug profile →
- Saline
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
Guangzhou Women and Children's Medical Center
Who can join
Adults 2 to 15, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by qualitative abnormalities in reciprocal social interactions and patterns of communication, and by a restricted, stereotyped, repetitive repertoire of interests and activities. The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications specifically in this population. The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03434366
- Europe PMC full search
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- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Currently open trials in the same condition.
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Other Guangzhou Women and Children's Medical Center trials
Trials by the same sponsor.
- NCT07190001 — YOLT-204 in Patients With Hemoglobinopathies · EARLY_PHASE1 · not yet recruiting
- NCT06904729 — Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children · Phase 3 · recruiting
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- NCT06856759 — Single-Dose AAV-MECP2 Safety/Tolerability and Efficacy in Rett Syndrome · EARLY_PHASE1 · recruiting
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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 NCT03434366 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guangzhou Women and Children's Medical Center
- Last refreshed: 12 April 2022
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/NCT03434366.
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