A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)

• Status: Terminated
• Trial end date: 2019-01-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA, Darmstadt, Germany
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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