Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-19

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages).

Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis.

One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis.

The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis.

The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?

NCT03983720

Sclerosis, Multiple

TERMINATED PHASE2

FOCUS Fatigue Outcome in Copaxone USers

NCT00267319

Multiple Sclerosis

COMPLETED PHASE4

A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina

NCT01080001

Multiple Sclerosis, Relapsing-remitting

COMPLETED

Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

NCT04002102

Multiple Sclerosis Fatigue

COMPLETED NA

OFSEP Very High Definition Cohort

NCT05622643

Multiple Sclerosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Two-year patient follow-up is planned with data collection at 0, 12 and 24 months.

In addition to data already collected as part of the establishment and monitoring of the ReLSEP registry, more specific data for this study will be collected at 0, 12 and 24 months by self-questionnaires sent to patients' homes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient \> or = 18 years old
* Patient with Multiple Sclerosis according to Mc Donald's diagnostic criteria
* Patient registered in the RelSEP registry
* Being able to fill out a questionnaire
* Person who has received complete information on the organization of the research and who has not objected to the exploitation of his data

Exclusion Criteria

* Patients no longer residing in Lorraine
* Bedridden patients
* Patients under guardianship, curatorship or safeguard of justice
* Patients with other serious pathologies with heavy treatments (eg cancer under chemotherapy or radiotherapy).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No