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

Phase 2TerminatedNCT03387046

Merck KGaA, Darmstadt, Germany7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

D-aspartateDIETARY_SUPPLEMENT

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

PlaceboDRUG

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

IFN beta-1aBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (17)

Ospedale Binaghi, Università di Cagliari,ASL 8

Cagliari, Italy

Ospedale Clinicizzato SS. Annunziata

Chieti, Italy

Outcomes

Primary Outcomes

Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).

Time frame: Baseline, Week 8

Secondary Outcomes

Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis. It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).

Time frame: Baseline, Week 12 and 24

25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment

The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The participants is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance. Participants may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. The data for the 25-FWT is reported for the 2 completed trials. Participant wise data was reported for this outcome.

Time frame: At Week 8, 12 and 24

9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment

The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The data for the 29HPT is reported for the 2 completed trials. Participant wise data was reported for this outcome.

Data from ClinicalTrials.gov

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