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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
D-aspartate
Placebo
IFN beta-1a
Methylprednisolone
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Relapsing remitting multiple sclerosis, D-Aspartate, interferon beta-1a

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Binaghi, Università di Cagliari,ASL 8
  • Ospedale Clinicizzato SS. Annunziata
  • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
  • Azienda Ospedaliero Universitaria San Martino
  • Ospedale P.A.Micone
  • Ospedale San Raffaele
  • A.O.U. Federico II
  • Azienda Ospedaliera di Rilievo Nazionale A. CardarelliAzienda Ospedaliera di Rilievo Nazionale A. Cardarelli
  • Seconda Università degli Studi di Napoli
  • Azienda Ospedaliera di Padova
  • I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Policlinico Universitario Agostino Gemelli
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Ospedale S. Paolo
  • Azienda Ospedaliero Universitaria Ospedali Riuniti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-aspartate + IFN beta-1a + Methylprednisolone

Placebo + IFN beta-1a + Methylprednisolone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome.
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome.
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome.
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome.
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome.
Number of Treated Participants With Immune-metabolic Response of Lymphocytes
Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported.

Full Information

First Posted
December 22, 2017
Last Updated
February 6, 2020
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03387046
Brief Title
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
Acronym
INCREASE
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early due to slow recruitment rate.
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Relapsing remitting multiple sclerosis, D-Aspartate, interferon beta-1a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-aspartate + IFN beta-1a + Methylprednisolone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + IFN beta-1a + Methylprednisolone
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
D-aspartate
Intervention Description
D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks.
Intervention Type
Biological
Intervention Name(s)
IFN beta-1a
Intervention Description
IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days.
Primary Outcome Measure Information:
Title
Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
Description
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 Outcome Measure Information:
Title
Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
Description
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
Title
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Description
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
Title
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Description
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.
Time Frame
Week 8, 12 and 24
Title
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Description
Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome.
Time Frame
At Week 8, 12 and 24
Title
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Description
Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome.
Time Frame
Week 8, 12 and 24
Title
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Description
MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome.
Time Frame
Week 8, 12 and 24
Title
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Description
Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome.
Time Frame
Week 8, 12 and 24
Title
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Description
TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome.
Time Frame
Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8
Title
Number of Treated Participants With Immune-metabolic Response of Lymphocytes
Description
Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported.
Time Frame
Baseline, Week 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Binaghi, Università di Cagliari,ASL 8
City
Cagliari
Country
Italy
Facility Name
Ospedale Clinicizzato SS. Annunziata
City
Chieti
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
City
Gallarate
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
Country
Italy
Facility Name
Ospedale P.A.Micone
City
Genova
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
A.O.U. Federico II
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale A. CardarelliAzienda Ospedaliera di Rilievo Nazionale A. Cardarelli
City
Napoli
Country
Italy
Facility Name
Seconda Università degli Studi di Napoli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
City
Pozzilli
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Rome
Country
Italy
Facility Name
Ospedale S. Paolo
City
Savona
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette Di Ancona
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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