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

NCT03387046 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-02-10

Study results available
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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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DIETARY_SUPPLEMENT

D-aspartate

D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks.

DRUG

Placebo

Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks.

BIOLOGICAL

IFN beta-1a

IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks.

DRUG

Methylprednisolone

Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-01-11
Completion
2019-01-11

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387046 on ClinicalTrials.gov