Trial · NCT03387046
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
NCT03387046, Phase 2, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2020-02-10
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ConductScience Library. A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS). Trials, record NCT03387046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03387046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
- NCT number
- NCT03387046
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- D-aspartate, Placebo, IFN beta-1a, Methylprednisolone
- First posted
- 2017-12-29
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
- Limitations and caveats
- Study was prematurely terminated, due to slow recruitment rate.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | 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 | 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). |
| Secondary | 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | At Week 8, 12 and 24 | 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. |
| Secondary | 9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Week 8, 12 and 24 | 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. |
| Secondary | Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | At Week 8, 12 and 24 | 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. |
| Secondary | Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Week 8, 12 and 24 | 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. |
| Secondary | Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24 | 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. |
| Secondary | Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24 | 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. |
| Secondary | Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS) | Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8 | 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. |
| Secondary | Number of Treated Participants With Immune-metabolic Response of Lymphocytes | Baseline, Week 8 and 12 | Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | At Week 8, 12 and 24 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | Seconds | NUMBER |
| SECONDARY | 9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Week 8, 12 and 24 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | Seconds | NUMBER |
| SECONDARY | Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | At Week 8, 12 and 24 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | units on a scale | NUMBER |
| SECONDARY | Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | Week 8, 12 and 24 | Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, Number of participants analyzed signifies those who were evaluable for this endpoint and number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | Letters read correctly | NUMBER |
| SECONDARY | Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24 | Week 8, 12 and 24 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | units on a scale | NUMBER |
| SECONDARY | Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24 | Week 8, 12 and 24 | Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint. | units on a scale | NUMBER |
| SECONDARY | Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS) | Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8 | Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, Number of participants analyzed signifies those who were evaluated for this endpoint and number analyzed signifies specific participant evaluated in respective arm. | millivolts | NUMBER |
| SECONDARY | Number of Treated Participants With Immune-metabolic Response of Lymphocytes | Baseline, Week 8 and 12 | Data was not collected since the study was prematurely terminated, due to slow recruitment rate. |
Source ClinicalTrials.gov
Results by group222
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | Participants | ||
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 | Placebo + IFN Beta-1a + Methylprednisolone | 0 | Participants | ||
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | D-aspartate + IFN Beta-1a + Methylprednisolone | Week 12 | 1 | Participants | |
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | Placebo + IFN Beta-1a + Methylprednisolone | Week 12 | 0 | Participants | |
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | D-aspartate + IFN Beta-1a + Methylprednisolone | Week 24 | 1 | Participants | |
| Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24 | Placebo + IFN Beta-1a + Methylprednisolone | Week 24 | 0 | Participants | |
| 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | D-aspartate + IFN Beta-1a + Methylprednisolone | Participant 1: Trial 1: Week 8 | 13.1 | Seconds | |
| 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | D-aspartate + IFN Beta-1a + Methylprednisolone | Participant 1: Trial 2: Week 8 | 12.4 | Seconds | |
| 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | D-aspartate + IFN Beta-1a + Methylprednisolone | Participant 2: Trial 1: Week 8 | 12.7 | Seconds | |
| 25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment | D-aspartate + IFN Beta-1a + Methylprednisolone | Participant 2: Trial 2: Week 8 | 12.6 | Seconds |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | D-aspartate + IFN Beta-1a + Methylprednisolone | 5 | |
| Overall Study | STARTED | Placebo + IFN Beta-1a + Methylprednisolone | 2 | |
| Overall Study | COMPLETED | D-aspartate + IFN Beta-1a + Methylprednisolone | 4 | |
| Overall Study | COMPLETED | Placebo + IFN Beta-1a + Methylprednisolone | 1 | |
| Overall Study | NOT COMPLETED | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | |
| Overall Study | NOT COMPLETED | Placebo + IFN Beta-1a + Methylprednisolone | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypersexuality | Reproductive system and breast disorders | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | 5 | |
| other | Hypersexuality | Reproductive system and breast disorders | Placebo + IFN Beta-1a + Methylprednisolone | 0 | 2 | |
| other | Flu-like symptoms | Infections and infestations | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | 5 | |
| other | Flu-like symptoms | Infections and infestations | Placebo + IFN Beta-1a + Methylprednisolone | 1 | 2 | |
| other | Weight gain | General disorders | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | 5 | |
| other | Weight gain | General disorders | Placebo + IFN Beta-1a + Methylprednisolone | 0 | 2 | |
| other | Pain in the left thigh | General disorders | D-aspartate + IFN Beta-1a + Methylprednisolone | 1 | 5 | |
| other | Pain in the left thigh | General disorders | Placebo + IFN Beta-1a + Methylprednisolone | 0 | 2 | |
| other | Periorbital pain | Eye disorders | D-aspartate + IFN Beta-1a + Methylprednisolone | 0 | 5 | |
| other | Periorbital pain | Eye disorders | Placebo + IFN Beta-1a + Methylprednisolone | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D-aspartate + IFN Beta-1a + Methylprednisolone | 0 | 5 |
| Total, all-cause mortality | Placebo + IFN Beta-1a + Methylprednisolone | 0 | 2 |
| Total, other adverse events | D-aspartate + IFN Beta-1a + Methylprednisolone | 3 | 5 |
| Total, other adverse events | Placebo + IFN Beta-1a + Methylprednisolone | 2 | 2 |
| Total, serious adverse events | D-aspartate + IFN Beta-1a + Methylprednisolone | 0 | 5 |
| Total, serious adverse events | Placebo + IFN Beta-1a + Methylprednisolone | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
D-aspartate + IFN Beta-1a + Methylprednisolone vs Placebo + IFN Beta-1a + Methylprednisolone: Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8 | Trial comparisons |
| D-aspartate + IFN Beta-1a + Methylprednisolone vs Placebo + IFN Beta-1a + Methylprednisolone: deaths from any cause | Trial comparisons |
| D-aspartate + IFN Beta-1a + Methylprednisolone vs Placebo + IFN Beta-1a + Methylprednisolone: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03387046
GET https://conductscience.org/api/trials/v1/NCT03387046/results?page=2