Multiple SclerosisNCT04100343
Detection of Pattern of Some Unusual Signs and Symptoms of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Assiut University.
Trial summary
Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include all patients daignosed as multiple sclerosis attending at Assiut university hospital within the prescribed time
Who may be able to join
- Male or female.
- Age:30-50 years
- Accepting all study requirement
Who cannot join
- comorbid patient e.g (diabetic, hypertensive.......etc )
- opposition of the patient or their family
About this study
Official title: Detection of Pattern of Unusual Signs and Symptoms of Multiple Sclerosis
Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on International Headache Society (IHS) recommendations
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
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 posted24 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmood Mohammed Yosry Abdelsatar Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100343
- Sponsor's protocol ID
- Unusual multiple sclerosis
- Status last verified
- Oct 2019
- First submitted
- 17 Sep 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pattern of Unusual Signs and Symptoms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04100343
- Acronym / sponsor ID
- Unusual multiple sclerosis
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 24 Sep 2019 (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.
Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on International Headache Society (IHS) recommendations
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include all patients daignosed as multiple sclerosis attending at Assiut university hospital within the prescribed time
Key inclusion criteria (3 listed)
- Male or female.
- Age:30-50 years
- Accepting all study requirement
Key exclusion criteria (2 listed)
- comorbid patient e.g (diabetic, hypertensive.......etc )
- opposition of the patient or their family
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
Fatigue severity scale
Time frame: 1 year
A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, 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 2 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 4 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (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 4 Oct 2019.