A Phase 3 interventional study of Dexamethasone acetate and dexamethasone and cyclophosphamide in Opsoclonus Myoclonus Syndrome and Neuroblastoma, sponsored by Institut Curie. Completed at 36 sites in 7 countries. Open to participants aged 6 Months to 8 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Institut Curie · Phase 3, Interventional, and Treatment
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.
675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.
This study's enrollment of 102 is above the median of 32 across 507 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →Institut Curie is the lead sponsor of 135 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Three out of the following four components are necessary for the diagnosis of OMS/DES:
Neuroblastoma The diagnosis of OMS/DES may be difficult in some patients. Opsoclonus, in particular, may be intermittent or late in onset. A video example will be available at www.dancingeyes.org.uk. If uncertain, please contact the national coordinator for support in interpreting clinical features.
Exclusion Criteria:
•Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).
An identified viral precursor is not an exclusion criterion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexamethasone acetate · Drug: dexamethasone and cyclophosphamide · Drug: dexamethasone and rituximab
First step: immunosuppressive treatment with dexamethasone
Drug pages: Dexamethasone · Cyclophosphamide
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
Drug pages: Dexamethasone · Rituximab
third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab
The response to treatment schedule as defined by the percentage of patients with disappearance of all symptoms.
Time frame: at 48 weeks after treatment start
Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting information: Statistical analysis plan
Time frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
No publications or documents are linked to this record.
Ran from Apr 2013 to primary completion in May 2021, 96 months.
Of 19 phase 3 interventional studies under Neuroblastoma, half reached primary completion within 96 months of starting (the median), counting those still running; a quarter within 80 and three quarters within 122. This study's 96 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexamethasone acetate · Dexamethasone · Cyclophosphamide · Rituximab