NCT01868269

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)

Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opsoclonus Myoclonus Syndrome
• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Dexamethasone acetate	First step: 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

Timeline

• Start date: 2013-04-18
• Primary completion: 2021-05-09
• Completion: 2025-01-17
• First posted: 2013-06-04
• Last updated: 2025-02-03

Locations

36 sites across 7 countries: Austria, France, Italy, Spain, Sweden, Switzerland, United Kingdom