A prospective, multi-centre study investigating the incidence and prognosis of relapses, pseudo-relapses and other causes of (sub)acute neurological symptoms in patients with relapsing-remitting multiple sclerosis.

A prospective, multi-centre study investigating the incidence and prognosis of relapses, pseudo-relapses and other causes of (sub)acute neurological symptoms in patients with relapsing-remitting multiple sclerosis. - RELAMS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55562

Enrollment

600

Registered

2019-08-23

Start date

2020-02-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * The subject must give written informed consent * The subject is between the age of *18 and *55 years * The subject suffers from RRMS or CIS * The subject has an EDSS of 5.5 or less prior to baseline (e.g. ambulatory without aid for about 100 meters) * The subject has experienced (sub)acute neurological symptoms within 14 days before visit * The subject must be prepared to and considered able to follow the protocol during the whole trial period and to attend the planned visits

Exclusion criteria

Exclusion criteria: * The subject has received treatment with glucocorticoids within one month prior to the inclusion in the study * The subject has experienced a relapse within one month prior to inclusion in the study * The subject has already been included in this study during a previous episode of symptoms

Design outcomes

Primary

Measure	Time frame
The percentage of patients with neurological deterioration based on relapse, pseudo-relapse or other mimics. The cause of deterioration is determined by the treating neurologist, based on history taking, neurological examination, laboratory results and if available MRI and when in doubt on the panel's opinion.	—

Secondary

Measure	Time frame
* The duration, severity (measured on the EDSS/physical examination, comparison based on available information on previous neurological examination and history taking to determine FSS prior to relapse, and patient reported outcomes on the impact on daily activities) and prognosis (no, partial or complete recovery, based on available information on previous neurological examination and patients judgement) of relapses/pseudo-relapses/mimics The diagnostic tools (history taking, EDSS, MRI, laboratory tests) which guide a neurologist to diagnose the cause of the deterioration * Serum NFL	—

Measure

Time frame

* The duration, severity (measured on the EDSS/physical examination, comparison based on available information on previous neurological examination and history taking to determine FSS prior to relapse, and patient reported outcomes on the impact on daily activities) and prognosis (no, partial or complete recovery, based on available information on previous neurological examination and patient*s judgement) of relapses/pseudo-relapses/mimics * The diagnostic tools (history taking, EDSS, MRI, laboratory tests) which guide a neurologist to diagnose the cause of the deterioration * Serum NFL

—

Countries

Netherlands

Outcome results