Multinational européan trial for children with the opsoclonus myoclonus syndrome/dancing eye syndrome.

Multinational européan trial for children with the opsoclonus myoclonus syndrome/dancing eye syndrome. - OMS

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000990-29-SE

Enrollment

100

Registered

2013-05-24

Start date

2013-07-03

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 16.0 Level: PT Classification code 10053854 Term: Opsoclonus myoclonus System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: CYCLOPHOSPHAMIDE Pharmaceutical Form: Solution for injection Product Name: DEXAMETHASONE Pharmaceutical Form: Solution for injection Product Name: RITUXIMAB Pharmaceutical Form: Soluti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: •children with newly diagnosed OMS/DES (with or without neuroblastoma) using the diagnostic criteria of this trial • no prior use of immunosuppressive medication •staging for neuroblastoma according the guidelines of the trial •age > 6 months and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: exclusion criteria: •opsoclonus, myoclonus or ataxia caused by other diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary endpoint: •response to treatment at 48 weeks after treatment start ;Secondary Objective: Secondary endpoints: •response at 3 months, 6 months, 12 months, and 2 years after treatment start •number of OMS/DES relapses •percentage of OMS-NBpos •need for chemotherapy in OMS-NBpos •evaluation of treatment burden (neurological and oncological treatment) •comparison of OMS-NBpos and OMS-NBneg in terms of presentation, severity and treatment response •neuropsychological longterm outcome •long term quality of life •evaluation of factors influencing long term outcome and quality of life •comparison of long term outcome to other OMS cohorts •Event free Survival and Overall survival in OMS-NBpos ;Primary end point(s): Response to treatme nt at 48 weeks after treatment start.;Timepoint(s) of evaluation of this end point: 48 weeks after treatment start.	—

Measure

Time frame

Main Objective: Primary endpoint: •response to treatment at 48 weeks after treatment start ;Secondary Objective: Secondary endpoints: •response at 3 months, 6 months, 12 months, and 2 years after treatment start •number of OMS/DES relapses •percentage of OMS-NBpos •need for chemotherapy in OMS-NBpos •evaluation of treatment burden (neurological and oncological treatment) •comparison of OMS-NBpos and OMS-NBneg in terms of presentation, severity and treatment response •neuropsychological longterm outcome •long term quality of life •evaluation of factors influencing long term outcome and quality of life •comparison of long term outcome to other OMS cohorts •Event free Survival and Overall survival in OMS-NBpos ;Primary end point(s): Response to treatme nt at 48 weeks after treatment start.;Timepoint(s) of evaluation of this end point: 48 weeks after treatment start.

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Secondary

Measure	Time frame
Secondary end point(s): Response at 3 months, 6 months, 12 months, and 2 years after treatment start Number of OMS/DES relapses percentage of OMS-NBpos. Evaluation of treatment burden (neurological and oncological treatment) Comparison of OMS-NBpos and OMS-NBneg in terms of presentation, severity and treatment response. Neuropsychological longterm outcome Long term quality of life Evaluation of factors influencing long term outcome and quality of life Comparison of long term outcome to other OMS cohorts Event free survival and overall survival in OMS-NBpos.	—

Measure

Time frame

Secondary end point(s): Response at 3 months, 6 months, 12 months, and 2 years after treatment start Number of OMS/DES relapses percentage of OMS-NBpos. Evaluation of treatment burden (neurological and oncological treatment) Comparison of OMS-NBpos and OMS-NBneg in terms of presentation, severity and treatment response. Neuropsychological longterm outcome Long term quality of life Evaluation of factors influencing long term outcome and quality of life Comparison of long term outcome to other OMS cohorts Event free survival and overall survival in OMS-NBpos.

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Countries

Austria, Belgium, France, Italy, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public ContactEmmanuelle BOUFFIER

INSTITUT CURIE

emmanuelle.bouffier@curie.net33156245765

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026