NCT04239820Active, not recruitingPhase 4
Effect of Cladribine Treatment on Microglial Activation in the CNS
Source: ClinicalTrials.gov · Last updated 15 Jan 2025
Brief summary (registry, in English)
To evaluate the effect of cladribine treatment on microglial activation with conventional MRI, QSM-post processing and TSPO-PET imaging in late stage relapsing remitting multiple sclerosis patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Observational
- Enrollment
- 15 (actual)
- First submitted
- 21 Jan 2020
- Start date
- 10 Jan 2020
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- Turku University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT04239820
- EU CT number
- 2024-519921-39-00
- EudraCT number
- 2019-001960-31
What you commit to
- Study type: Observational · Phase 4
- Participants enrolled: 15
- From 10 Jan 2020 to the primary completion date, 15 Feb 2024
- 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
- Corticosteroid treatment within 4 weeks of imaging
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
- Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
- Patients with previous alemtuzumab administration
- Patients with less than 1 month since previous administration of other disease modifying therapy
Other illness
- Patients with other neurodegenerative disease than MS
- Patients with human immunodeficiency virus (HIV).
- Patients with active chronic infection (tuberculosis or hepatitis).
- Patients with active malignancy.
- Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
Lab values
- Abnormal lymphocyte counts
- Patients with moderate or severe renal impairment (creatinine clearance \<60 mL/min)
- Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts)
Other
- Patients that are pregnant or breast-feeding
- Patients with significant abnormal findings other than MS in the screening MRI.
- Contraindication to PET scan investigations
Who the study is looking for
- Signing the informed consent form
- Cladribine treatment is planned and indicated and is according to label
- 45-55 years of age at the time of signing the research informed consent form
- RRMS diagnosis in accordance with McDonald 2017 criteria
Age in the registry: 45 years to 55 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 |
|---|---|---|---|
| Varsinais-Suomen hyvinvointialue Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
Related publications
- Impact of Oral Cladribine on TSPO-PET-Measurable Immune Cell Activation in Multiple Sclerosis.Neurol Ther · 2026 · PMID 42814343
This page is information, not medical advice. Discuss any trial with your doctor.