Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with RR-MS, according to the revised McDonald Criteria (2010)
Participants with an expanded disability status scale (EDSS) score between 0 and 3 before screening visit and before relapse
Participants receiving treatment with IFN beta 1a 44 mcg three times a week for at least 6 months but for no more than 10 years before the screening visit
Female participants must be neither pregnant nor breastfeeding and must lack childbearing potential
Participants willing and able to comply with the protocol for the total duration of the study
Participants able to understand the purposes and the risks of the study
Participants have signed the appropriate written informed consent form, approved by the Independent Ethics Committee (IEC), prior to the performance of any study activities
For MS participants with relapse:
Deterioration of at least one step in a relevant Functional Systems Scale (FSS) or an increase in EDSS of 1 point or more compatible, according to physician's judgment, with the therapy prosecution
Relapse started within maximum 5 days before the inclusion in the study
MS participants without relapse with clinically stable RR-MS
You may not be if
Participants with diagnosis of primary progressive MS (PP-MS)
Participants have any disease other than MS that could better explain his/her signs and symptoms
Participants with any comorbidity with diseases that might alter synaptic plasticity (example Parkinson Disease, Alzheimer Disease, Stroke)
Participants receiving concomitant treatment with drugs that may alter synaptic plasticity (example, cannabinoids)
Participants with history or presence of any unstable medical condition (tumor or chronic infection or severe life threatening infection within the last 6 months)
Participants who have received any corticosteroids therapy within 3 months prior to the screening
Participants with any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressive agents during the course of the study
Participants who have received any immunosuppressive agents other to corticosteroids, as monotherapy or combination therapy within 3 months prior to the screening visit
Participants with history or currently active primary or secondary immunodeficiency
Participants with inadequate liver function, defined by alanine aminotransferase (ALT) \> 3 \* upper limit of normal (ULN), or alkaline phosphatase (AP) \> 2 \* ULN, or total bilirubin \> 2 \* ULN if associated with any elevation of ALT or AP
Participants with inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 \* lower limit of normal (LLN)
Participants with moderate to severe renal impairment
Participants unable to complete an magnetic resonance imaging (MRI) (contraindications for MRI include but are not restricted to weight \>=140 kilogram (kg), pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc)
Participants with contraindication to gadolinium (Gd) can be enrolled into the study but cannot receive Gd contrast dyes during their MRI scans
Participants receiving supplements that, in the Investigator's opinion, may affect the evaluation of fatigue
Participants with any known contraindications or hypersensitivity to D-aspartate or any excipient
Participants with any other significant disease that in the Investigator's opinion would impede study assessments or endanger the participant
Female participants with positive pregnancy test at baseline or participants with active project of pregnancy during the study
Participants with legal incapacity or limited legal capacity
Participants have participated in any other investigational study within 8 weeks before the screening visit
Clareo Health | A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
