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)
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|ClinicalTrials.gov Identifier: NCT01868269|
Recruitment Status : Recruiting
First Posted : June 4, 2013
Last Update Posted : February 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Opsoclonus Myoclonus Syndrome Neuroblastoma||Drug: Dexamethasone acetate Drug: dexamethasone and cyclophosphamide Drug: dexamethasone and rituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome|
|Actual Study Start Date :||April 18, 2013|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||April 2031|
|Dexamethasone Cyclophosphamide Rituximab||
Drug: Dexamethasone acetate
immunosuppressive treatment with dexamethasone
Drug: dexamethasone and cyclophosphamide
second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
Drug: dexamethasone and 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868269
|Contact: Anne JOCHEM, MDfirstname.lastname@example.org|
|Principal Investigator:||Gudrun Schleiermacher, MD||Institut Curie|