K Multicentre Study of Children with Opsoclonus Myoclonus Syndrome (UMSCOM)

• Conditions: Opsoclonus myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in children with and without neuroblastoma (NBpos and NBneg); MedDRA version: 16.0Level: PTClassification code 10053854Term: Opsoclonus myoclonusSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-000990-29-GB
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

For inclusion in the study all three numbered criteria below must be satisfied: 1) A diagnosis of OMS: Three out of the following four components must be evident: • Opsoclonus or ocular flutter (but not nystagmus) • Ataxia and/or myoclonus • Behavioural change and/or sleep disturbance • Neuroblastoma 2) Age at diagnosis between 6 months and 7 years (up to 8th birthday). 3) Signed informed consent has been given
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Opsoclonus, myoclonus or ataxia caused by another identified disease. 2. Prior or parallel use of chemotherapy (other than required for treatment of NB) 3. Steroid treatment lasting 14 days or more immediately before start of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified