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

NCT ID: NCT03387046

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-26
• Study Completion Date: 2019-01-11

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

D-aspartate + IFN beta-1a + Methylprednisolone

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.

Group Type: EXPERIMENTAL

D-aspartate

Intervention Type: DIETARY_SUPPLEMENT

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

IFN beta-1a

Intervention Type: BIOLOGICAL

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

Methylprednisolone

Intervention Type: DRUG

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

Placebo + IFN beta-1a + Methylprednisolone

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

IFN beta-1a

Intervention Type: BIOLOGICAL

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

Methylprednisolone

Intervention Type: DRUG

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

Interventions

D-aspartate

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DRUG

IFN beta-1a

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

Intervention Type: BIOLOGICAL

Methylprednisolone

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Ospedale Binaghi, Università di Cagliari,ASL 8

Cagliari, , Italy

Ospedale Clinicizzato SS. Annunziata

Chieti, , Italy

Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

Gallarate, , Italy

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Ospedale P.A.Micone

Genova, , Italy

Ospedale San Raffaele

Milan, , Italy

A.O.U. Federico II

Napoli, , Italy

Azienda Ospedaliera di Rilievo Nazionale A. CardarelliAzienda Ospedaliera di Rilievo Nazionale A. Cardarelli

Napoli, , Italy

Seconda Università degli Studi di Napoli

Napoli, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

Pozzilli, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, , Italy

Ospedale S. Paolo

Savona, , Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette Di Ancona, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MS200136_0041

Identifier Type: -

Identifier Source: org_study_id