Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    acute flaccid myelitis
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03499366
Recruitment Status : Unknown
Verified May 2018 by Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : April 17, 2018
Last Update Posted : May 11, 2018
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 Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03499366

Layout table for location contacts
Contact: Anette Ramm-Pettersen, MD, PhD 0047 23070000

Layout table for location information
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Helle CV Pfeiffer, MD. PhD    +47 23076182   
Sponsors and Collaborators
Oslo University Hospital
University Medical Center Groningen
National Health Service, United Kingdom
Layout table for investigator information
Study Chair: Anette ramm-Pettersen, MD, PhD Head of department
Layout table for additonal information
Responsible Party: Helle Cecilie Viekilde Pfeiffer, Researcher, Pricipal investigator, PhD, Department of Child Neurology, Oslo University Hospital Identifier: NCT03499366    
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

Layout table for additional information
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
acute flaccid myelitis
acute flaccid paresis
Additional relevant MeSH terms:
Layout table for MeSH terms
Enterovirus Infections
Neurologic Manifestations
Nervous System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases