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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03387046
• Date of registration: 22/12/2017
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA, Darmstadt, Germany
• Public title: A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS) INCREASE
• Scientific title: Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)
• Date of first enrolment: March 26, 2018
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03387046
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany, Italy

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Placebo

Biological: IFN beta-1a

Dietary Supplement: D-aspartate

Drug: Methylprednisolone

Primary Outcome(s)

Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 [Time Frame: Baseline, Week 8]

Secondary Outcome(s)

25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment [Time Frame: At Week 8, 12 and 24]

Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS) [Time Frame: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8]

Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24 [Time Frame: Week 8, 12 and 24]

Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment [Time Frame: Week 8, 12 and 24]

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

Number of Treated Participants With Immune-metabolic Response of Lymphocytes [Time Frame: Baseline, Week 8 and 12]

Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment [Time Frame: At Week 8, 12 and 24]

9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment [Time Frame: Week 8, 12 and 24]

Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24 [Time Frame: Week 8, 12 and 24]

Secondary ID(s)

MS200136_0041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03387046