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European Paediatric AFM Associated With EV-D68 Follow-up Study.

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ClinicalTrials.gov Identifier: NCT03499366
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
University Medical Center Groningen
National Health Service, United Kingdom
Information provided by (Responsible Party):
Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital

Brief Summary:
The study is a follow-up study on children with acute flaccid paresis associated with enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to clarify the outcome of the disease and investigate possible clinical correlation with outcome, including initial severity, demographic characteristics, treatment and MRI findings.

Condition or disease Intervention/treatment Phase
Flaccid Hemiplegia Flaccid Paraplegia Flaccid Tetraplegia, Unspecified Enterovirus D68 Myelitis, Infectious Diagnostic Test: HFMS, MRC, ACTIVLIM, PedsQl-4.0 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: HFMS, MRC, ACTIVLIM, PedsQl-4.0
    Clinical performance tests, quality of life, activity of daily life form.


Primary Outcome Measures :
  1. Total Hammersmith Functional Motor scale- score at follow-up [ Time Frame: 1 year ]

    O'Hagen, J. M., et al. (2007). "An expanded version of the Hammersmith Functional Motor Scale for SMA II and III patients." Neuromuscul Disord 17(9-10): 693-697.Neurol. 2003;7(4):155-9.

    The scale is a 33 items evaluation (0, 1 or 2 points in each item) and results in an overall functional score. Range: 0-66, with a higher score reflecting better performance. No sub-scores will be used.




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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute flaccid paresis (AFP) at onset, and
  • Enterovirus D-68 polymerase chain reaction (PCR) positive in any specimen in a timely sample (+/- 3 weeks from onset of paresis), and
  • Age <18 years at onset, and
  • Magnetic resonance imaging (MRI) of spine and brain at onset with signs of myelitis.

Exclusion Criteria:

  • Major trauma
  • central nervous system (CNS) malignancy
  • Bleeding or infarctions in CNS
  • Previous demyelinating disease
  • Other infections cause of myelitis is more likely
  • Patient and/or legal guardian is not able/willing to sign the consent form

Information from the National Library of Medicine

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): NCT03499366


Contacts
Contact: Anette Ramm-Pettersen, MD, PhD 0047 23070000 arammpet@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Helle CV Pfeiffer, MD. PhD    +47 23076182    helvie@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
University Medical Center Groningen
National Health Service, United Kingdom
Investigators
Study Chair: Anette ramm-Pettersen, MD, PhD Head of department

Responsible Party: Helle Cecilie Viekilde Pfeiffer, Researcher, Pricipal investigator, PhD, Department of Child Neurology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03499366     History of Changes
Other Study ID Numbers: 2017/2123
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital:
enterovirus D68
AFP
AFM
EV-D68
acute flaccid myelitis
acute flaccid paresis

Additional relevant MeSH terms:
Hemiplegia
Quadriplegia
Paraplegia
Enterovirus Infections
Myelitis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases