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.

Completed

Conditions: Multiple sclerosis
10012303

Registration Number: NL-OMON55562

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 125

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

* 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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