Acute Disseminated EncephalomyelitisADEM diseaseNCT07540182
The Aim of the Present Study is to Determine Outcome Predictors in Children Who Were Diagnosed as Acute Disseminated Encephalomyelitis (ADEM).
An observational study of Acute Disseminated Encephalomyelitis and Encephalomyelitis, run by Assiut University.
Trial summary
The aim of the present study is to determine outcome predictors in children who were diagnosed as acute disseminated encephalomyelitis (ADEM). Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Acute Disseminated Encephalomyelitis, Encephalomyelitis, Encephalopathy
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2026to Apr 2027
- How long will I take part?
- 25 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged from 6 months old to 18 years. 2. Presence of clinical signs of acute encephalopathy with multifocal neurological deficits
Who may be able to join
- Children aged from 6 months old to 18 years.
- Presence of clinical signs of acute encephalopathy with multifocal neurological deficits.
- MRI findings suggestive of demyelinating lesions.
Who cannot join
- Pediatric patients diagnosed who were as multiple sclerosis.
- Pediatric patients with clinical signs and radiological findings suggestive of neuromyelitis optica spectrum disorder.
- Pediatric patients with infectious encephalitis.
- Pediatric patients with metabolic or genetic neurological disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcome Predictors in Children With Acute Disseminated Encephalomyelitis at Assuit University Children Hospital
The aim of the present study is to determine outcome predictors in children who were diagnosed as acute disseminated encephalomyelitis (ADEM).
Read the detailed description
Outcome predictors in children with Acute Disseminated Encephalomyelitis
- Keywords
- ADEM, Pediatric Encephalomyelitis, Demyelinating Disorders
- Medical subject headings
- Encephalomyelitis, Acute Disseminated, Encephalomyelitis, Brain Diseases, Demyelinating Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Complete Recovery Assessed by the Modified Rankin Scale (mRS)
Functional disability and recovery are assessed using the Modified Rankin Scale (mRS), a validated 7-point scale ranging from 0 to 6. A score of 0 indicates no symptoms at all, 5 indicates severe disability (bedridden, requiring constant care), and 6 indicates death. For this study, complete recovery is defined as achieving an mRS score of 0 or 1 (no significant disability). This measure reports the percentage of participants who meet this specific recovery criteria.
Measured: 6 months
Secondary outcomes (2)
Incidence of Disease Relapse
This measure evaluates the percentage of participants who experience a new inflammatory demyelinating event. As per the study protocol, a relapse is specifically defined as the onset of a new neurological event occurring more than 3 months after the patient's initial clinical recovery.
Measured: up to 12 months
Incidence of Residual Neurological Deficits
This measure reports the proportion of participants who exhibit long-term cognitive or motor sequelae following the acute disease phase. The presence or absence of these residual deficits is determined through standard clinical neurological examinations conducted during outpatient follow-up.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start29 Mar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Disseminated EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 25 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norma Samy Gergis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540182
- Sponsor's protocol ID
- ADEM disease
- Acronym
- ADEM disease
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang CX. Assessment and Management of Acute Disseminated Encephalomyelitis (ADEM) in the Pediatric Patient. Paediatr Drugs. 2021 May;23(3):213-221. doi: 10.1007/s40272-021-00441-7. Epub 2021 Apr 8.
PubMed 33830467Sechi E, Krecke KN, Messina SA, Buciuc M, Pittock SJ, Chen JJ, Weinshenker BG, Lopez-Chiriboga AS, Lucchinetti CF, Zalewski NL, Tillema JM, Kunchok A, Monaco S, Morris PP, Fryer JP, Nguyen A, Greenwood T, Syc-Mazurek SB, Keegan BM, Flanagan EP. Comparison of MRI Lesion Evolution in Different Central Nervous System Demyelinating Disorders. Neurology. 2021 Sep 14;97(11):e1097-e1109. doi: 10.1212/WNL.0000000000012467. Epub 2021 Jul 14.
PubMed 34261784Pohl D, Alper G, Van Haren K, Kornberg AJ, Lucchinetti CF, Tenembaum S, Belman AL. Acute disseminated encephalomyelitis: Updates on an inflammatory CNS syndrome. Neurology. 2016 Aug 30;87(9 Suppl 2):S38-45. doi: 10.1212/WNL.0000000000002825.
PubMed 27572859Ferenc K, Semik P, Paprocka J. Acute Disseminated Encephalomyelitis (ADEM): Current View into Etiopathogenesis and Clinical Features. Brain Sci. 2026 Feb 9;16(2):201. doi: 10.3390/brainsci16020201.
PubMed 41750202
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors in Children With Acute Disseminated Encephalomyelitis at Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT07540182
- Acronym / sponsor ID
- ADEM disease / ADEM disease
- Keywords
- ADEM, Pediatric Encephalomyelitis, Demyelinating Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Apr 2026 (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 aim of the present study is to determine outcome predictors in children who were diagnosed as acute disseminated encephalomyelitis (ADEM).
Detailed description
Outcome predictors in children with Acute Disseminated Encephalomyelitis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Months
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged from 6 months old to 18 years. 2. Presence of clinical signs of acute encephalopathy with multifocal neurological deficits
Key inclusion criteria (3 listed)
- Children aged from 6 months old to 18 years.
- Presence of clinical signs of acute encephalopathy with multifocal neurological deficits.
- MRI findings suggestive of demyelinating lesions.
Key exclusion criteria (4 listed)
- Pediatric patients diagnosed who were as multiple sclerosis.
- Pediatric patients with clinical signs and radiological findings suggestive of neuromyelitis optica spectrum disorder.
- Pediatric patients with infectious encephalitis.
- Pediatric patients with metabolic or genetic neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients Achieving Complete Recovery Assessed by the Modified Rankin Scale (mRS)
Time frame: 6 months
Functional disability and recovery are assessed using the Modified Rankin Scale (mRS), a validated 7-point scale ranging from 0 to 6. A score of 0 indicates no symptoms at all, 5 indicates severe disability (bedridden, requiring constant care), and 6 indicates death. For this study, complete recovery is defined as achieving an mRS score of 0 or 1 (no significant disability). This measure reports the percentage of participants who meet this specific recovery criteria.
2 secondary outcomes
Incidence of Disease Relapse
Time frame: up to 12 months
Incidence of Residual Neurological Deficits
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 33830467Wang CX. Assessment and Management of Acute Disseminated Encephalomyelitis (ADEM) in the Pediatric Patient. Paediatr Drugs. 2021 May;23(3):213-221. doi: 10.1007/s40272-021-00441-7. Epub 2021 Apr 8.
- Background: PubMed 34261784Sechi E, Krecke KN, Messina SA, Buciuc M, Pittock SJ, Chen JJ, Weinshenker BG, Lopez-Chiriboga AS, Lucchinetti CF, Zalewski NL, Tillema JM, Kunchok A, Monaco S, Morris PP, Fryer JP, Nguyen A, Greenwood T, Syc-Mazurek SB, Keegan BM, Flanagan EP. Comparison of MRI Lesion Evolution in Different Central Nervous System Demyelinating Disorders. Neurology. 2021 Sep 14;97(11):e1097-e1109. doi: 10.1212/WNL.0000000000012467. Epub 2021 Jul 14.
- Background: PubMed 27572859Pohl D, Alper G, Van Haren K, Kornberg AJ, Lucchinetti CF, Tenembaum S, Belman AL. Acute disseminated encephalomyelitis: Updates on an inflammatory CNS syndrome. Neurology. 2016 Aug 30;87(9 Suppl 2):S38-45. doi: 10.1212/WNL.0000000000002825.
- Background: PubMed 41750202Ferenc K, Semik P, Paprocka J. Acute Disseminated Encephalomyelitis (ADEM): Current View into Etiopathogenesis and Clinical Features. Brain Sci. 2026 Feb 9;16(2):201. doi: 10.3390/brainsci16020201.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Disseminated Encephalomyelitis and Encephalomyelitis, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norma S Girgis (00201274511337, samygergis104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving Complete Recovery Assessed by the Modified Rankin Scale (mRS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07540182, which also lists 4 linked publications.
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 20 Apr 2026.