Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS:
The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis.
The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.
Eligibility criteria
Qualifiers
Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria
Age 18-65 years
Stable MS disease at inclusion (definition: no clinical relapse, no MRI activity, stable disability within the last 12 months)
Unchanged immunotherapy within the last 12 months
Disqualifiers
Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis
Immunodeficiency other than hypogammaglobulinemia
Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy
Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) >16 points)
Trial design
Treatments tested in this trial
- Laboratory test
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov