Know Cancer

forgot password

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

Phase 3
6 Months
8 Years
Open (Enrolling)
Opsoclonus Myoclonus Syndrome, Neuroblastoma

Thank you

Trial Information

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

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 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, 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The response to treatment schedule as defined by the percentage of patients with disappearance of all symptoms.

Outcome Time Frame:

at 48 weeks after treatment start

Safety Issue:


Principal Investigator

Gudrun Schleiermacher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

IC 2011-02



Start Date:

February 2013

Completion Date:

Related Keywords:

  • Opsoclonus Myoclonus Syndrome
  • Neuroblastoma
  • Myoclonus
  • Neuroblastoma
  • Ocular Motility Disorders
  • Opsoclonus-Myoclonus Syndrome