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)
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| ClinicalTrials.gov Identifier: NCT01868269 |
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Recruitment Status :
Active, not recruiting
First Posted : June 4, 2013
Last Update Posted : May 18, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opsoclonus Myoclonus Syndrome Neuroblastoma | Drug: Dexamethasone acetate Drug: dexamethasone and cyclophosphamide Drug: dexamethasone and rituximab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome |
| Actual Study Start Date : | April 18, 2013 |
| Estimated Primary Completion Date : | February 2027 |
| Estimated Study Completion Date : | April 2031 |
| Arm | Intervention/treatment |
|---|---|
| Dexamethasone Cyclophosphamide Rituximab |
Drug: Dexamethasone acetate
First step: immunosuppressive treatment with dexamethasone Drug: dexamethasone and cyclophosphamide second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide Drug: dexamethasone and rituximab third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab |
- 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 ]
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| Ages Eligible for Study: | 6 Months to 8 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868269
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| Principal Investigator: | Gudrun Schleiermacher, MD | Institut Curie |
| Responsible Party: | Institut Curie |
| ClinicalTrials.gov Identifier: | NCT01868269 |
| Other Study ID Numbers: |
IC 2011-02 |
| First Posted: | June 4, 2013 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
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Neuroblastoma Opsoclonus-Myoclonus Syndrome Myoclonus Ocular Motility Disorders Syndrome Disease Pathologic Processes Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Dyskinesias Neurologic Manifestations Nervous System Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Paraneoplastic Syndromes Neurodegenerative Diseases Dexamethasone Dexamethasone acetate Cyclophosphamide |