a pilot study in participants with relapsing remitting multiple sclerosis (rr-ms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

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

Keywords: relapsing remitting multiple sclerosis d-aspartate interferon beta-1a