Multiple SclerosisNCT06994026
Feasibility Study of a Relapse Investigation Questionnaire Administered by an MS Care Coordinator Nurse in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Disease Management, run by Centre Hospitalier de Gonesse at 1 site in France.
Trial summary
This study aims to evaluate a questionnaire used by a specialized nurse to help manage relapses in people with multiple sclerosis (MS). The questionnaire is completed during a phone call when the patient reports new or worsening symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Disease Management, Feasibility Studies
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2025to 15 Aug 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The participants will be selected from adult patients with Multiple Sclerosis (MS) who are under the care of Dr. Manchon at a single neurology center. Specifically, the population includes individuals diagnosed with either Relapsing-Remitting MS or active Secondary Progressive MS. All participants must have provided informed consent to be included in a local task-sharing protocol that allows a specialized nurse (IDEC) to conduct initial evaluations during suspected relapses. This population reflects patients who are actively monitored for MS and may experience acute neurological symptoms requiring timely assessment and intervention.
Who may be able to join
- Patients followed by Dr. Manchon for Relapsing-Remitting Multiple Sclerosis or active Secondary Progressive Multiple Sclerosis
- Adult patients (aged 18 or older)
- Patients who have provided informed consent for participation in the local task-sharing protocol
Who cannot join
- Pregnant women
- Minors (under 18 years old)
- Patients with known renal failure
- Patients who have not provided or are unable to provide consent for the local task-sharing protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
France
Gonesse, France
Audrey SAOUD, +330134532464, coordination.rechercheclinique@ghtpdfr.fr
About this study
This study aims to evaluate a questionnaire used by a specialized nurse to help manage relapses in people with multiple sclerosis (MS). The questionnaire is completed during a phone call when the patient reports new or worsening symptoms. It helps the nurse decide whether further tests or treatments are needed, based on a protocol developed with a neurologist. The goal is to improve how quickly and effectively patients receive care during a relapse. The study will include 10 adult patients with active forms of MS over a two-month period.
- Conditions
- Multiple Sclerosis, Disease Management, Feasibility Studies
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the relapse investigation questionnaire completed by the MS care coordinator nurse (IDEC) in guiding the patient's care pathway during a suspected relapse, according to the local task-sharing protocol.
Measured: June 2025 - August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (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.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Gonesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994026
- Sponsor's protocol ID
- 0062_NEUROLOGIE_TIPO
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Relapse Investigation Questionnaire Administered by an MS Care Coordinator Nurse in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06994026
- Acronym / sponsor ID
- 0062_NEUROLOGIE_TIPO
- Conditions
- Multiple Sclerosis, Disease Management, Feasibility Studies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier de GonesseUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 29 May 2025 (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.
This study aims to evaluate a questionnaire used by a specialized nurse to help manage relapses in people with multiple sclerosis (MS). The questionnaire is completed during a phone call when the patient reports new or worsening symptoms. It helps the nurse decide whether further tests or treatments are needed, based on a protocol developed with a neurologist. The goal is to improve how quickly and effectively patients receive care during a relapse. The study will include 10 adult patients with active forms of MS over a two-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected from adult patients with Multiple Sclerosis (MS) who are under the care of Dr. Manchon at a single neurology center. Specifically, the population includes individuals diagnosed with either Relapsing-Remitting MS or active Secondary Progressive MS. All participants must have provided informed consent to be included in a local task-sharing protocol that allows a specialized nurse (IDEC) to conduct initial evaluations during suspected relapses. This population reflects patients who are actively monitored for MS and may experience acute neurological symptoms requiring timely assessment and intervention.
Key inclusion criteria (3 listed)
- Patients followed by Dr. Manchon for Relapsing-Remitting Multiple Sclerosis or active Secondary Progressive Multiple Sclerosis
- Adult patients (aged 18 or older)
- Patients who have provided informed consent for participation in the local task-sharing protocol
Key exclusion criteria (4 listed)
- Pregnant women
- Minors (under 18 years old)
- Patients with known renal failure
- Patients who have not provided or are unable to provide consent for the local task-sharing protocol
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
Effectiveness of the relapse investigation questionnaire completed by the MS care coordinator nurse (IDEC) in guiding the patient's care pathway during a suspected relapse, according to the local task-sharing protocol.
Time frame: June 2025 - August 2025
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 29 May 2025.
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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.
1 site 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 and Disease Management, run by Centre Hospitalier de Gonesse at 1 site in France.
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 29 May 2025. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the relapse investigation questionnaire completed by the MS care coordinator nurse (IDEC) in guiding the patient's care pathway during a suspected relapse, according to the local task-sharing protocol. (time frame: June 2025 - August 2025). 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 29 May 2025.