Stopped earlyPhase 2Relapsing MSNCT03387046

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Study was terminated early due to slow recruitment rate.

What was tested

Treatment tested

  • D-aspartate
  • Interferon beta-1a

    Interferon alpha/beta receptor agonist

  • Methylprednisolone

    Glucocorticoid receptor agonist

Placebo or sham

  • Placebo

Results by group

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

Baseline, Week 8

GroupValueIntervalNumber analysed
D-aspartate + IFN Beta-1a + Methylprednisolone1 Participants5
Placebo + IFN Beta-1a + Methylprednisolone0 Participants2

D-aspartate + IFN Beta-1a + Methylprednisolone

1

Placebo + IFN Beta-1a + Methylprednisolone

0

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
D-aspartate + IFN Beta-1a + Methylprednisolone50 (0.0%)0
Placebo + IFN Beta-1a + Methylprednisolone20 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    Baseline, Week 8

    Disability progressionBladder, bowel and sexual function

Other measures (9)

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

    Baseline, Week 12 and 24

    Disability progressionBladder, bowel and sexual function
  • 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment

    At Week 8, 12 and 24

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

    Week 8, 12 and 24

    Disability progressionThinking and memoryArm and hand function
  • Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment

    At Week 8, 12 and 24

    Thinking and memory
  • Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment

    Week 8, 12 and 24

    VisionThinking and memory
  • Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

    Week 8, 12 and 24

    Fatigue
  • Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

    Week 8, 12 and 24

    FatigueMood and sleep
  • Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

    Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

    Myelin repairNerve conduction tests
  • Number of Treated Participants With Immune-metabolic Response of Lymphocytes

    Baseline, Week 8 and 12

    Immune response

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Mar 2018

      2. Main results due

        Jan 2019

      3. Finished

        Jan 2019

      4. Results posted

        Feb 2020

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