MedTrace Logo

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)

NCT01868269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-02-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Gudrun Schleiermacher, MD · Institut Curie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-18
Primary Completion
2021-05-09
Completion
2025-01-17

Countries

  • Austria
  • France
  • Italy
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01868269 on ClinicalTrials.gov