EpilepsyNCT04106284
Comorbidities of Epilepsy
An observational study of Epilepsy, run by Assiut University.
Trial summary
Epilepsy is the second commonest chronic neurological disorder in developed countries, Comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects included will be chosen from Epilepsy out patient clinic and Neurology department at Assiut University Hospital.
Who may be able to join
- Patients diagnosed as primary epilepsy either newly diagnosed or on AEDs
- Aged above 18 years old
- Males and females
Who cannot join
- Patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc).
- Patients diagnosed as epilepsy syndrome
About this study
Epilepsy is the second commonest chronic neurological disorder in developed countries, Comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA Scan
DEXA scan to measure bone mineral density at 3 points (wrist joint ,hip joint and lumbo-sacral vertebrae)
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 posted27 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasnaa abdalla, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106284
- Sponsor's protocol ID
- Comorbidities of epilepsy
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 1 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidities of Epilepsy
- ClinicalTrials.gov ID
- NCT04106284
- Acronym / sponsor ID
- Comorbidities of epilepsy
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 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.
Epilepsy is the second commonest chronic neurological disorder in developed countries, Comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included will be chosen from Epilepsy out patient clinic and Neurology department at Assiut University Hospital.
Key inclusion criteria (3 listed)
- Patients diagnosed as primary epilepsy either newly diagnosed or on AEDs
- Aged above 18 years old
- Males and females
Key exclusion criteria (2 listed)
- Patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc).
- Patients diagnosed as epilepsy syndrome
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
DEXA Scan
Time frame: 1 year
DEXA scan to measure bone mineral density at 3 points (wrist joint ,hip joint and lumbo-sacral vertebrae)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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 Epilepsy, 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 1 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?
DEXA Scan (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 1 Oct 2019.