Multinational European Trial for Children with theOpsoclonus Myoclonus Syndrome / Dancing Eye SyndromeOMS/DES

Conditions: Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-000990-29-ES

Lead Sponsor: Institut Curie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 0

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
?Age 6 months or over up to less than 8 years (< 8th birthday)
?Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol
?In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial
?Documented informed consent for treatment and enrolment in the trial by parents / legal representatives .
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)