Flaccid HemiplegiaNCT03499366
European Paediatric AFM Associated With EV-D68 Follow-up Study.
A study testing HFMS, MRC, ACTIVLIM, PedsQl-4.0 in people with Flaccid Hemiplegia and Flaccid Paraplegia, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Flaccid Hemiplegia, Flaccid Paraplegia, Flaccid Tetraplegia, Unspecified
- What is being tested?
- HFMS, MRC, ACTIVLIM, PedsQl-4.0
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 9 Apr 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Helle CV Pfeiffer, MD. PhD, +47 23076182, helvie@ous-hf.no
About this study
Official title: A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
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.
Read the detailed description
Title: Clinical observational follow-up study of children with Acute Flaccid Myelitis associated with EV-D68 infection- a cross European collaboration.
Study objectives: To study the clinical outcome and function of patients with Acute Flaccid Myelitis associated with enterovirus (EV)-D68 infection after 1 to 3 years, in order to assist clinicians in providing prognoses for patients and to guide further investigation.
Primary objective will be:
- Functional assessment using the Hammersmith Functional Motor Scale (HFMS) -score at follow up; 1, 2 and three years depending on time of debut
Secondary objectives are to describe these secondary outcomes and their changes over time, from onset to 1, 2 and 3 years, depending on time of debut:
- Medical Research Council (MRC) sum score at acute illness and at 1, 2 and 3 years follow up depending on time of debut as well as possible improvements over time
- MRC score in the most affected joint at acute illness and at 1, 2 and 3 years follow up depending on time of debut, as well as possible improvements over time ACTIVLIM functional score at 1, 2 and 3 years follow up depending on time of debut
- Quality of life at 1, 2 and 3 years follow up depending on time of onset measured using the Paediatric Quality of Life Inventory (PedsQL) 4.0.
- Number of days needing intensive care (range and mean)
- Number of days needing mechanical ventilation (range and mean)
- Number of deaths will be reported
- Number of complete recoveries will be reported
Explorative objectives:
- Exploring demographic parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring different treatments and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring different clinical parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring time aspects of the recovery process (individual MRC-score and MRC sum score changes).
- Characteristics on MRI will be explored with regards to outcome measures (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- In cases with repeated MRI scans, changes will be described
- In cases with repeated neurophysiological examinations, changes will be described.
Clinical study/intervention design: This is a clinical observational study aiming at including all registered European AFM-EVD68 patients less than 18 years of age.
Safety endpoints: There is no treatment given in this study. If we become aware of important safety issues concerning included patient's treatment regimens or supportive treatment the responsible treating physician well be informed promptly via e-mail.
Duration of study: The study is intended to produce follow up data every year for two years. Inclusion will begin in March 2018 and the study terminates in March 2020. Analysis of data might hereafter continue for one year.
Follow-up: The study is a follow up study itself. Follow up will be done as close to 1 year after onset as possible and hereafter every year for minimal 2 years.
The study is intended as a clinical follow-up study exploring the outcome of patients with acute flaccid paresis associated with enterovirus D68. The patients will undergo a standard neurologic examination and assessment using Hammersmith functional motor scale expanded. The parents/ child will be asked to fill out a form concerning quality of life and activity of daily living. There will be no painful or invasive procedures and the duration of each visit can be expected to be approx. 4 hours.
- Conditions
- Flaccid Hemiplegia, Flaccid Paraplegia, Flaccid Tetraplegia, Unspecified, Enterovirus D68, Myelitis, Infectious
- Being tested
- HFMS, MRC, ACTIVLIM, PedsQl-4.0
- Keywords
- enterovirus D68, AFP, AFM, EV-D68, acute flaccid myelitis, acute flaccid paresis
- Medical subject headings
- Hemiplegia, Paraplegia, Quadriplegia, Myelitis, acute flaccid myelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFMS, MRC, ACTIVLIM, PedsQl-4.0Diagnostic test
Clinical performance tests, quality of life, activity of daily life form.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hammersmith Functional Motor scale- score at follow-up
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start9 Apr 2018
- Primary completion9 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flaccid HemiplegiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, National Health Service, United Kingdom
- Responsible party
- Principal investigator, Helle Cecilie Viekilde Pfeiffer, Oslo University Hospital
- Investigators
- Anette ramm-Pettersen, MD, PhD, Study chair, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499366
- Sponsor's protocol ID
- 2017/2123
- Status last verified
- May 2018
- First submitted
- 9 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
- ClinicalTrials.gov ID
- NCT03499366
- Acronym / sponsor ID
- 2017/2123
- Conditions
- Flaccid Hemiplegia, Flaccid Paraplegia, Flaccid Tetraplegia, Unspecified, Enterovirus D68, Myelitis, Infectious
- Keywords
- enterovirus D68, AFP, AFM, EV-D68, acute flaccid myelitis, acute flaccid paresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, National Health Service, United Kingdom
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 9 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title: Clinical observational follow-up study of children with Acute Flaccid Myelitis associated with EV-D68 infection- a cross European collaboration.
Study objectives: To study the clinical outcome and function of patients with Acute Flaccid Myelitis associated with enterovirus (EV)-D68 infection after 1 to 3 years, in order to assist clinicians in providing prognoses for patients and to guide further investigation.
Primary objective will be:
- Functional assessment using the Hammersmith Functional Motor Scale (HFMS) -score at follow up; 1, 2 and three years depending on time of debut
Secondary objectives are to describe these secondary outcomes and their changes over time, from onset to 1, 2 and 3 years, depending on time of debut:
- Medical Research Council (MRC) sum score at acute illness and at 1, 2 and 3 years follow up depending on time of debut as well as possible improvements over time
- MRC score in the most affected joint at acute illness and at 1, 2 and 3 years follow up depending on time of debut, as well as possible improvements over time ACTIVLIM functional score at 1, 2 and 3 years follow up depending on time of debut
- Quality of life at 1, 2 and 3 years follow up depending on time of onset measured using the Paediatric Quality of Life Inventory (PedsQL) 4.0.
- Number of days needing intensive care (range and mean)
- Number of days needing mechanical ventilation (range and mean)
- Number of deaths will be reported
- Number of complete recoveries will be reported
Explorative objectives:
- Exploring demographic parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring different treatments and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring different clinical parameters and how it relates to outcome (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- Exploring time aspects of the recovery process (individual MRC-score and MRC sum score changes).
- Characteristics on MRI will be explored with regards to outcome measures (HFMS/ MRC-score/ ACTIVLIM/ PedsQL 4.0)
- In cases with repeated MRI scans, changes will be described
- In cases with repeated neurophysiological examinations, changes will be described.
Clinical study/intervention design: This is a clinical observational study aiming at including all registered European AFM-EVD68 patients less than 18 years of age.
Safety endpoints: There is no treatment given in this study. If we become aware of important safety issues concerning included patient's treatment regimens or supportive treatment the responsible treating physician well be informed promptly via e-mail.
Duration of study: The study is intended to produce follow up data every year for two years. Inclusion will begin in March 2018 and the study terminates in March 2020. Analysis of data might hereafter continue for one year.
Follow-up: The study is a follow up study itself. Follow up will be done as close to 1 year after onset as possible and hereafter every year for minimal 2 years.
The study is intended as a clinical follow-up study exploring the outcome of patients with acute flaccid paresis associated with enterovirus D68. The patients will undergo a standard neurologic examination and assessment using Hammersmith functional motor scale expanded. The parents/ child will be asked to fill out a form concerning quality of life and activity of daily living. There will be no painful or invasive procedures and the duration of each visit can be expected to be approx. 4 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Major trauma
- central nervous system (CNS) malignancy
- Bleeding or infarctions in CNS
- Previous demyelinating disease
- Other infections cause of myelitis is more likely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFMS, MRC, ACTIVLIM, PedsQl-4.0Clinical performance tests, quality of life, activity of daily life form. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette ramm-Pettersen, MD, PhD study chair
Head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFMS, MRC, ACTIVLIM, PedsQl-4.0 in people with Flaccid Hemiplegia and Flaccid Paraplegia, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anette Ramm-Pettersen, MD, PhD (0047 23070000, arammpet@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Hammersmith Functional Motor scale- score at follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.