Status:
RECRUITING
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Hypogammaglobulinemia
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 be...
Detailed Description
Multiple sclerosis (MS) is the most common cause of mental and physical disability in young adults affecting approximately 10'000-15'000 persons in Switzerland (incidence 16/100000; prevalence 190/100...
Eligibility Criteria
Inclusion
- 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
- Expanded Disability Status Scale (EDSS) level \<4 points indicating fully ambulatory patients.
- Capability of written informed consent
Exclusion
- 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)
- Fatigue aggravating factors such: liver/renal/thyroid dysfunction, substance abuse, medication (tranquilizers /antiepileptics/psychopharmaceuticals), chronic infectious disease (like hepatitis/HIV).
- Other neurodegenerative/autoimmune disease.
- Patients not able to give written consent
- Vulnerable patients such as children, pregnant women and prisoners
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05357781
Start Date
July 1 2022
End Date
December 30 2026
Last Update
March 30 2025
Active Locations (1)
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1
University Hospital of Bern Inselspital
Bern, Canton of Bern, Switzerland, 3010