Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? (NCT05357781) | Clinical Trial Compass
RecruitingNot Applicable
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Switzerland106 participantsStarted 2022-07-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with fatigue and hypogammaglobulinemia
Timeframe: 1.5 years
2
Number of patients with fatigue without hypogammaglobulinemia