NCT05357781Recruiting
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? - A Prospective Observational Fatigue Trial
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 106 (estimated)
- First submitted
- 19 Apr 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Multiple sclerosis
- NCT number
- NCT05357781
What you commit to
- Study type: Observational
- Planned participants: 106
- From 1 Jul 2022 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy
Other illness
- Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis
- Fatigue aggravating factors such: liver/renal/thyroid dysfunction, substance abuse, medication (tranquilizers /antiepileptics/psychopharmaceuticals), chronic infectious disease (like hepatitis/HIV).
- Other neurodegenerative/autoimmune disease.
Other
- Immunodeficiency other than hypogammaglobulinemia
- Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) \>16 points)
- Patients not able to give written consent
- Vulnerable patients such as children, pregnant women and prisoners
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Bern (Inselspital) Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.