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)

Sponsor
Institut Curie
Study ID
NCT01868269
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone acetate — DRUG
    First step: immunosuppressive treatment with dexamethasone
  • dexamethasone and cyclophosphamide — DRUG
    second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
  • dexamethasone and rituximab — DRUG
    third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab

Study Details

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.

Key Dates

Start date
Apr 18, 2013
Status verified
Jan 2025
Primary completion
May 9, 2021
Completion
Jan 17, 2025

Study Design

Enrollment
102 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Dexamethasone Cyclophosphamide Rituximab

Primary Outcome Measure

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 ]

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