A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
The purpose of this study was to evaluate the improvement in spontaneous recovery from
 clinical deficits at the time of an acute relapse in RR-MS participants already receiving
 interferon (IFN) beta 1a with D-aspartate (versus placebo) as add-on therapy.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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