Clinical trial NCT03387046
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing remitting multiple sclerosis D-Aspartate interferon beta-1a
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2018-03-26; Completion date: 2019-01-11
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse. arm 2: Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
Interventions: intervention 1: D-aspartate intervention 2: Placebo intervention 3: IFN beta-1a intervention 4: Methylprednisolone
Intervention descriptions: intervention 1: D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks. intervention 2: Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks. intervention 3: IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks. intervention 4: Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days.

Protocol documents:
Prot_SAP_000.pdf: 
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