Completed

NCT Number: 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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opsoclonus Myoclonus Syndrome Central Nervous System Diseases Cranial Nerve Diseases Dyskinesias Eye Diseases Myoclonus Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neurodegenerative Diseases Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neurologic Manifestations Ocular Motility Disorders Opsoclonus-Myoclonus Syndrome Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with newly diagnosed OMS/DES either NB-pos or NB-neg.

Three out of the following four components are necessary for the diagnosis of OMS/DES:

Opsoclonus or ocular flutter (but not nystagmus)
Ataxia and/or myoclonus
Behavioural change and/or sleep disturbance
Neuroblastoma The diagnosis of OMS/DES may be difficult in some patients. Opsoclonus, in particular, may be intermittent or late in onset. A video example will be available at www.dancingeyes.org.uk. If uncertain, please contact the national coordinator for support in interpreting clinical features.

Age 6 months or over up to less than 8 years (< 8th birthday) The date of diagnosis of OMS/DES is the date on which a doctor confirms the condition to be OMS/DES. The date of symptom onset needs also to be documented.
Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol (see 11.10, page 71).
In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial (see chapter 4.4.1.4, page 30, and appendix 11.9, page 70)
Documented informed consent for treatment and enrolment in the trial by parents / legal representatives.

Exclusion criteria

•Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).

An identified viral precursor is not an exclusion criterion.

prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)
Corticoid steroid for OMS/DES or other reasons lasting 14 days or more immediately before treatment start according the standard treatment proposed (treatment with corticosteroids for less than 14 days will be allowed)
contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)

Treatment and study plan

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2021
Study completion: 2025
First posted: Jun 4, 2013
Registry last updated: Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting