Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT01868269
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2013-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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:
Organization:
Raw JSON
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Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with newly diagnosed OMS/DES either NB-pos or NB-neg.\n\nThree out of the following four components are necessary for the diagnosis of OMS/DES:\n\n* Opsoclonus or ocular flutter (but not nystagmus)\n* Ataxia and/or myoclonus\n* Behavioural change and/or sleep disturbance\n* 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.\n\n * 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.\n * 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).\n * 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)\n * Documented informed consent for treatment and enrolment in the trial by parents / legal representatives.\n\nExclusion Criteria:\n\n•Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).\n\nAn identified viral precursor is not an exclusion criterion.\n\n* prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)\n* 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)\n* contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)'}, 'identificationModule': {'nctId': 'NCT01868269', 'briefTitle': '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)', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome', 'orgStudyIdInfo': {'id': 'IC 2011-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dexamethasone Cyclophosphamide Rituximab', 'interventionNames': ['Drug: Dexamethasone acetate', 'Drug: dexamethasone and cyclophosphamide', 'Drug: dexamethasone and rituximab']}], 'interventions': [{'name': 'Dexamethasone acetate', 'type': 'DRUG', 'description': 'First step:\n\nimmunosuppressive treatment with dexamethasone', 'armGroupLabels': ['Dexamethasone Cyclophosphamide Rituximab']}, {'name': 'dexamethasone and cyclophosphamide', 'type': 'DRUG', 'description': 'second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide', 'armGroupLabels': ['Dexamethasone Cyclophosphamide Rituximab']}, {'name': 'dexamethasone and rituximab', 'type': 'DRUG', 'description': 'third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab', 'armGroupLabels': ['Dexamethasone Cyclophosphamide Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': "St. Anna Kinderkrebsforschung e.V. 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Documents generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}