Reduced lymphocyte count. Reduced white bloodcell count.
Conditions
Interventions
All subjects enrolled in this study will be administered deuterated water for 9
weeks. The administration of deuterated water is a methodological intervention,
and as such deuterated water is not re
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria, MS patients - male and female subjects; - minimal age 18 years at the time of informed consent; - confirmed relapsing remitting multiple sclerosis (RRMS) patients, with: - a diagnosis of RRMS according to the revised McDonald criteria; - a baseline score of 0 to 5.0 on the Expanded Disability Status Scale; - patients on Tecfidera treatment for at least 6 months; - ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.;Inclusion criteria, healthy subjects - healthy male and female subjects; - minimal age of 18 years at the time of informed consent; - ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.
Exclusion criteria
Exclusion criteria: Exclusion criteria, MS patients - positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), and/or hepatitis B surface antigen (HbsAg) at screening; - evidence of any active or chronic disease or condition, other than MS (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subject; - a treatment history that includes steroids within one month prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period); - body weight
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Protein or lipid composition and incorporation of deuterium in stratum corneum proteins or lipids, including ceramides and other lipid classes. | — |
Primary
| Measure | Time frame |
|---|---|
| Standard safety: - nature, frequency, and severity of adverse events; - concomitant medication. Immuno-monitoring: - total leukocyte count and (automated) differential count; - immunophenotyping for absolute cell counts of the target populations (CD4+ T-cells, naïve and memory CD8+ T-cells, CD19+ B-cells) from whole blood, including Annexin V expression and PI incorporation (FACS); - mitochondrial membrane potential for target populations (Mitoscreen according to GBS SOP T272E, from PBMCs, when sufficient material is available); - lymphocyte dynamics per isolated target population* (deuterium incorporation by GCMS, after immunomagnetic purification of target populations from PBMCs): o production rate; o disappearance rate. * also requires assessment of deuterium enrichment in granulocytes and deuterium enrichment in urine (GCMS) The specific markers mentioned above are indicative. Other or additional markers may be selected, as long as no deviation is made from the number and volume of blood samples reported in the study protocol. | — |
Countries
Netherlands
Outcome results
None listed