Trial · NCT07898371
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Socio-demographic Characteristics | Baseline | Number and percentage of participants with socio-demographic characteristics including age, gender, occupational status will be collected. |
| Primary | Disease History: Most Recent Disability Status Scale (EDSS) score | Baseline | Disease history including EDSS score will be collected. The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5. |
| Primary | Disease History: EDSS Progression in Past 12 Months | Baseline | Disease history including EDSS progression in past 12 Months will be collected. The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5. |
| Primary | Disease History: Time Since Relapsing-Remitting Multiple Sclerosis (RRMS) Symptom Onset | Baseline | Disease history including time (in years) since RRMS symptom onset will be collected. |
| Primary | Disease History: Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis | Baseline | Disease history including time (in years) since SPMS diagnosis will be collected. |
| Primary | Disease History: Time Since Most Recent Clinical Relapse | Baseline | Disease history including time (in years) since most recent clinical relapse will be collected. |
| Primary | Disease History: Number and Type of Previous MS Treatments | Baseline | Disease history including number and type of previous MS treatments will be collected. |
| Primary | Disease History: Number and Type of Prior and Current Disease Modifying Therapies (DMTs) | Baseline | Disease history including number and type prior and current DMTs will be collected. |
| Primary | Disease History: Number of Participants with Comorbidities | Baseline | Disease history including comorbidities will be collected. |
| Primary | Disease History: Number of Participants with Medical History | Baseline | Disease history including medical history will be collected. |
| Primary | Disease History: Number of Participants with Concomitant Medication | Baseline | Disease history including concomitant medication will be collected. |
| Primary | Magnetic Resonance Imaging Data | Baseline | MRI data will be collected. |
| Secondary | Change from Baseline in Individual Expanded Disability Status Scale (EDSS) Score | Baseline up to 36 months | The EDSS is a clinician-rated scale, ranging from 0 (normal neurological status) and 10 (death due to MS). Patients with EDSS score up to 4.5 are fully ambulant. Up to this point, the main determinant of EDSS are functional systems (FS), the ambulation status is the main determinant in the degree of disability after 4.5. |
| Secondary | Change from Baseline in Timed 25-Foot Walk Test (T25FW) | Baseline up to 36 months | The mean walk time will be used for assessment of the patient's walking ability. An increase of more than 20 percent (%) from the baseline in the T25-FW test is considered meaningful worsening. |
| Secondary | Change from Baseline in 9-Hole Peg Test (9-HPT) | Baseline up to 36 months | Time to complete the 9-HPT will be used to assess a participant's manual dexterity and fine motor skills. The mean time to test completion will serve for assessment of the patient's hand dexterity. An increase of more than 20 percent (%) from the baseline in the 9-HPT is considered meaningful worsening. |
| Secondary | Change from Baseline in Symbol Digit Modalities Test (SDMT) | Baseline up to 36 months | The SDMT is used to assess visual scanning, tracking and motor speed, and has been designed to detect cognitive impairment. The SDMT involves a simple substitution task that normal children and adults can easily perform. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. |
| Secondary | Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) | Baseline up to 36 months | The MSIS-29 is a scale that measures the physical (20 items) and psychological (9 items) impact of MS. Two summary scores (eg, the physical scale and the psychological scale) are calculated by summing up individual items in each scale and transforming the scores into a 0-100 scale. High scores indicate a higher impact of MS on the patient's physical and/or psychological health. |
| Secondary | Change from Baseline in Short Form Health Survey (SF-36) The | Baseline up to 36 months | The SF-36 is a 36-item questionnaire designed to measure health-related quality of life. It assesses eight domains of health, including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, and mental health. |
| Secondary | Change from Baseline in Multiple Sclerosis International Quality of Life (MuSIQoL) | Baseline up to 36 months | The MusiQoL questionnaire is a 31-item, MS-specific tool that measures quality of life from the patient's perspective. It covers nine domains-daily activities, psychological well-being, symptoms, relationships with friends and family, sentimental/sexual life, coping, and experiences of rejection-plus an overall index score. Items use a five-point scale, with higher scores reflecting better quality of life. |
| Secondary | Change from Baseline in Multiple Sclerosis Walking Scale (MSWS-12) | Baseline up to 36 months | The 12-item MSWS is a validated patient-reported measure of the impact of MS on the individual's walking ability. A low MSWS-12 score indicates minimal impact of MS on walking ability, reflecting better mobility and fewer limitations in daily activities. Conversely, a high MSWS-12 score indicates a greater impact of MS on walking reflecting more significant mobility impairment and increased difficulty performing walking-related tasks. |
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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