NCT06994026

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 20, 2025

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    June 2025 - August 2025

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Gonesse, France, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

June 15, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations