A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: D-aspartate; Placebo; IFN beta-1a; Methylprednisolone
Intervention description: D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks.; Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks.; IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks.; Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing remitting multiple sclerosis; D-Aspartate; interferon beta-1a

Summary:

      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.
    

Eligibility criteria:

        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