NCT01868269 is a Phase 3 clinical trial of Dexamethasone acetate in Opsoclonus Myoclonus Syndrome, sponsored by Institut Curie.

Who is sponsoring NCT01868269?

NCT01868269 is sponsored by Institut Curie.

What drugs are being tested in NCT01868269?

Interventions in NCT01868269: Dexamethasone acetate, dexamethasone and cyclophosphamide, dexamethasone and rituximab.

What condition does NCT01868269 study?

NCT01868269 studies Opsoclonus Myoclonus Syndrome, Neuroblastoma.

Is NCT01868269 still recruiting?

NCT01868269 is currently completed. Last updated 3 February 2025.

Last reviewed 2025-02-03 · How we verify

NCT01868269

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)

Completed Phase 3 Last updated 3 February 2025

What this trial tests

Phase 3 trial testing Dexamethasone acetate in Opsoclonus Myoclonus Syndrome in 102 participants. Completed in 17 January 2025.

Timeline

18 April 2013

Primary endpoint
9 May 2021

17 January 2025

Quick facts

Lead sponsor	Institut Curie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	18 April 2013
Primary completion	9 May 2021
Estimated completion	17 January 2025
Sites	36 locations across France, Italy, Austria, Sweden, United Kingdom, Switzerland, Spain

Drugs / interventions tested

Dexamethasone acetate (DEXAMETHASONE ACETATE) — full drug profile →
dexamethasone and cyclophosphamide — full drug profile →
dexamethasone and rituximab — full drug profile →

Conditions studied

Opsoclonus Myoclonus Syndrome — all drugs for Opsoclonus Myoclonus Syndrome →
Neuroblastoma — all drugs for Neuroblastoma →

Sponsor

Institut Curie — full company profile →

Who can join

Adults 6 Months to 8, any sex, with Opsoclonus Myoclonus Syndrome or Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome. This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma). This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Trial Watch: Tumor-targeting monoclonal antibodies in cancer therapy.
Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 54× · PMID 24605265 · DOI 10.4161/onci.27048
Diagnosis and Management of Opsoclonus-Myoclonus-Ataxia Syndrome in Children: An International Perspective.
Rossor T, Yeh EA, Khakoo Y, Angelini P, et al · · 2022 · cited 47× · PMID 35260471 · DOI 10.1212/nxi.0000000000001153
Evolving Cognitive Dysfunction in Children with Neurologically Stable Opsoclonus-Myoclonus Syndrome.
Goh EL, Scarff K, Satariano S, Lim M, et al · · 2020 · cited 5× · PMID 32824925 · DOI 10.3390/children7090103
Use Cases Requiring Privacy-Preserving Record Linkage in Paediatric Oncology.
Hayn D, Kreiner K, Sandner E, Baumgartner M, et al · · 2024 · cited 1× · PMID 39123424 · DOI 10.3390/cancers16152696

Verify or expand the search:

Other trials of Dexamethasone acetate

Trials testing the same drug.

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NCT02855866 — Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroi · NA · completed

Other Institut Curie trials

Trials by the same sponsor.

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NCT07193394 — Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer · Phase 2 · recruiting
NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01868269 (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 Institut Curie
Last refreshed: 3 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/NCT01868269.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing