Status:
COMPLETED
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)
Lead Sponsor:
Institut Curie
Conditions:
Opsoclonus Myoclonus Syndrome
Neuroblastoma
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief 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 Paed...
Eligibility Criteria
Inclusion
- 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
- •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)
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01868269
Start Date
April 18 2013
End Date
January 17 2025
Last Update
February 3 2025
Active Locations (36)
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1
St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE
Vienna, Austria, 1090
2
Chu de Bicetre
Le Kremlin-Bicêtre, LE Kremlin Bicetre, France, 94275
3
Centre Oscar Lambret
Lille, Lille Cedex, France, 59020
4
Centre Leon Berard
Lyon, LYON Cedex 08, France, 69373