Multiple Sclerosis RelapseNCT04237675
Postoperative Relapses in MS Patients
An observational study of Multiple Sclerosis Relapse and Surgery, run by University of Athens at 2 sites in Greece.
Trial summary
The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis Relapse, Surgery, Anesthesia
- What is being tested?
- surgery and anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesGreece
- Study dates
- 20 Dec 2019to Dec 2027
- How long will I take part?
- 1 Year
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients or parturients with MS who received general or regional anesthesia for surgery or labor analgesia
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Aretaieio Hospital, University of Athens
Athens, Attica, 11528
Chryssoula V Staikou, MD, +210 7286172, c_staikou@yahoo.gr
Chryssoula V Staikou, MD, DESA
- Recruiting
Aretaieio Hospital
Athens
Chryssoula V Staikou, Assoc Prof
About this study
Official title: Assessment of Risk of Postoperative Relapses in Patients With Multiple Sclerosis; an Observational Study
The aim of the study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia
- Conditions
- Multiple Sclerosis Relapse, Surgery, Anesthesia
- Being tested
- surgery and anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery and anesthesiaProcedure or surgery
patients with MS who received general or regional anesthesia for a surgery or labor
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | Not described Receives: Procedure: surgery and anesthesia | |
| general anesthesia | Not described Receives: Procedure: surgery and anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
MS relapses
number of relapses
Measured: one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Dec 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis RelapseStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staikou Chryssoula, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237675
- Sponsor's protocol ID
- 157/19-12-19
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Risk of Postoperative Relapses in Patients With Multiple Sclerosis; an Observational Study
- ClinicalTrials.gov ID
- NCT04237675
- Acronym / sponsor ID
- 157/19-12-19
- Conditions
- Multiple Sclerosis Relapse, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2020 (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 study is to record any relapses during one year postoperatively in patients and parturients diagnosed with MS who received general or regional anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | – | Procedure: surgery and anesthesia |
| general anesthesia | – | Procedure: surgery and anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients or parturients with MS who received general or regional anesthesia for surgery or labor analgesia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| surgery and anesthesiapatients with MS who received general or regional anesthesia for a surgery or labor | Procedure or surgery | general anesthesia, regional anesthesia |
Primary outcome
MS relapses
Time frame: one year postoperatively
number of relapses
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 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis Relapse and Surgery, run by University of Athens at 2 sites in Greece.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
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 Chryssoula V Staikou, Assoc Prof (00302107780172, c_staikou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MS relapses (time frame: one year postoperatively). 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 23 Jan 2020.