Veterans with MS: does ocrelizumab help with brain fog and tiredness?
NCT ID NCT07181811
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study will follow 30 veterans with multiple sclerosis who have been taking ocrelizumab for at least a year. Researchers will test their memory, attention, and fatigue levels at the start, 6 months, and 12 months using questionnaires and cognitive tests. The goal is to see how long-term ocrelizumab therapy relates to thinking skills and tiredness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab
- What this could lead to
- If successful, this could help doctors better understand and manage fatigue and cognitive issues in MS patients on ocrelizumab.
- What could go wrong
- This is a small, observational study with no control group, so results may not apply broadly. It only measures changes, not whether ocrelizumab causes them.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2025
An estimate. Start dates often move.
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75, men and women. * Confirmed diagnosis of Multiple Sclerosis (MS) (relapsing or progressive forms). * Expanded Disability Status Scale score between 0 and 7.5. * On continuous ocrelizumab therapy for at least 1 year. * Women of childbearing potential: Must agree to remain abstinent or use acceptable contraceptive methods during the study and for 6 months after the. last ocrelizumab dose; must have a negative pregnancy test before enrollment. Exclusion Criteria: * Patients without a confirmed diagnosis of MS based on McDonald 2017 Criteria. * Not on ocrelizumab therapy for at least 6 months prior to study start. * Currently receiving other disease-modifying therapies for MS in addition to Ocrelizumab. * Experienced an MS relapse or corticosteroid use within the last 30 months prior to enrollment. * History of major psychiatric conditions (severe depression, schizophrenia, bipolar disorder) interfering with assessments. * Significant cognitive impairment due to non-MS-related conditions (Traumatic brain injury, dementia, other neurodegenerative diseases). * Other major neurological disorders (e.g., Parkinson's, epilepsy, stroke). * History of alcohol or substance abuse within the past year. * Uncontrolled comorbidities (severe cardiovascular disease, diabetes with complications, renal/liver failure). * Uncorrected vision or hearing impairments interfering with cognitive testing. * Unable to provide informed consent due to cognitive or legal reasons. * Pregnant, lactating, or planning to become pregnant during the study period. * Currently enrolled in other interventional clinical trials affecting cognitive or fatigue outcomes. * Known presence of recurrent or chronic infections (Human Immunodeficiency Virus, syphilis, tuberculosis). * History or presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, Human T-lymphotropic virus type 1). * Active bacterial, viral, fungal, mycobacterial infection requiring recent hospitalization or IV antibiotics. * History of cancer (except treated basal cell, in situ squamous cell, or resolved cervical carcinoma). * History of or currently active primary or secondary immunodeficiency. * Severe allergic or anaphylactic reactions to monoclonal antibodies. * Systemic autoimmune disorders causing progressive neurological disease (e.g., lupus, Sjögren's). * Concomitant diseases requiring chronic systemic corticosteroid or immunosuppressant use. * Significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease. * History of other neurologic disorders (e.g., progressive multifocal leukoencephalopathy, central nervous system/spinal tumors, hereditary spastic paraparesis, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes syndrome, neuromyelitis optica-spectrum disorder). * Recent systemic corticosteroid therapy within 4 weeks prior to baseline. * Prior MS treatments with cyclophosphamide, mitoxantrone, or bone marrow transplant. * Receipt of live, attenuated, or inactivated/component vaccine within 6 weeks before enrollment. * Laboratory abnormalities: Positive hepatitis B markers, elevated liver enzymes (AST/ALT ≥2x ULN), cytopenias, low IgG/IgM.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple sclerosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
John D. Dingell VA Medical Center
Detroit, Michigan, 48201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise rebuild muscle and balance in MS?
- Can diet ease the crushing fatigue of multiple sclerosis?
- One-Time CAR-T infusion tested against progressive MS
- Can PET scans reveal hidden brain inflammation in MS?
- Can a pill rebuild the Brain's insulation? MS trial puts remyelination to the test
- Migraines and tension headaches may be hidden companions to multiple sclerosis