Trial · NCT03345940
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | effectiveness of fingolimod 0.5 mg once daily versus dimethyl-fumarate 240 mg twice daily | 24 Months | losing the NEDA status |
| Secondary | Annual relapse rate | over 12 and 24 months | compare the effectiveness of the two oral DMTs in terms of prevention of clinical relapses |
| Secondary | Number of Gd+ MRI lesions | at 12 and 24 months | compare the effectiveness of the two oral DMTs in terms of prevention of MRI activity |
| Secondary | Brain volume loss | at 12 and 24 months | compare the effectiveness of the two oral DMTs in terms of prevention of brain atrophy |
| Secondary | Prevention of sustained disability progression (EDSS worsening) | over 24 months | percentage of patients with confirmed increase of 1 point on the EDSS scale |
| Secondary | Prevention of Objective sustained disability progression | over 12 and 24 months | percentage of patients with change in gait performance (limb range of motion) assessed by inertial sensors |
| Secondary | Patient-NEDA | over 24 months | Percentage of patients maintaining patient-NEDA status |
| Secondary | Prevention of Cognitive decline | over 12 and 24 months | Change in cognitive impairment index (CII) assessed by Brief Repeatable Battery of Neuropsychological tests (BRB-N) |
| Secondary | Evaluation of social cognition | over 12 and 24 months | Change in social cognition assessed by Story based Empathy task (SET) |
| Secondary | Evaluation of quality of decision making | over 12 and 24 months | Change in quality of decision making assessed by Game of Dice Task (GDT) |
| Secondary | Preservation of Quality of life | over 12 and 24 months | Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 subscales along with 2 summary scores, and 2 additional single-item measures. The MSQOL-54 is a structured, self-report questionnaire that the patient can generally complete with little or no assistance. MSQOL-54 scale scores are expressed on a 0-100 scale: higher scores indicating better functioning. There is no single overall score. Two summary scores, physical health and mental health, can be derived from a weighted combination of scale scores. In addition there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, sexual function and satisfaction with sexual function and change in health. |
| Secondary | Convenience perception | over 12 and 24 months | Convenience perception as measured by the convenience scale within Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). The scores in each domain of the TSQM-9 will be calculated as recommended by the instrument's authors (Atkinson MJ, et all. Health Qual Life Outcomes. 2004 Feb 26; 2:12) |
| Secondary | Psychiatric symptoms | over 12 and 24 months | Symptomatic changes as determinated by Hospital Anxiety \& Depression Scale (HADS). HADS anxiety (HADS-A) and depression (HADS-D) scores range from 0 (no symptoms) to 21 (most severe Study Protocol, VS1 Page 26 of 48 symptoms). |
| Secondary | Fatigue | over 12 and 24 months | Symptomatic changes as determinated by Modified Fatigue Impact Scale (MFIS). The MFIS is a valid and reliable 21-question scale (score range, 0-84), with lower total scores indicating lower impact of fatigue on patient function. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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