Status:
TERMINATED
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03387046
Start Date
March 26 2018
End Date
January 11 2019
Last Update
February 10 2020
Active Locations (17)
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1
Ospedale Binaghi, Università di Cagliari,ASL 8
Cagliari, Italy
2
Ospedale Clinicizzato SS. Annunziata
Chieti, Italy
3
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
Gallarate, Italy
4
Azienda Ospedaliero Universitaria San Martino
Genova, Italy