There are 5 clinical trials
The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily can prevent worsening of walking ability in people secondary progressive MS. The number of participants in this study will be 62. A maximum of 75 people with secondary progressive MS will be included. Each patient will be followed for 12 months from inclusion. Domperidone is a medication which has been shown to increase levels of the hormone prolactin. The best understood function of prolactin is the stimulation of milk production in women after delivery. However, the increase in prolactin levels seen in patients treated with standard doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore may also improve myelin repair in people with MS. Domperidone is currently approved in Canada to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is available as a tablet that is usually taken four times per day. Doses up to 80mg per day may be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin repair. Domperidone is usually well tolerated.
Timed 25-Foot Walk (T25W). --- T25W ---
Description: quantitative ambulation performance test
Measure: Timed 25-Foot Walk (T25W) Time: up to 12 monthsDescription: brief, standardized, quantitative test of upper extremity
Measure: 9-Hole Peg Test Time: administered at baseline, one month, 6 months, and 12 monthsDescription: measures cognitive processing speed and working memory
Measure: Symbol Digit Modalities Test Time: administered at baseline, one month, 6 months, and 12 monthsDescription: EDSS is the standard measure of neurologic impairment that is used to describe disability in MS. The neurological assessment comprises seven functional systems.
Measure: Functional Systems and Expanded Disability Status Scale (EDSS) Time: administered at baseline, one month, 6 months, and 12 monthsDescription: structured, self-report questionnaire with 21 itmes concerning how fatigue impacts patient's life
Measure: Modified Fatigue Impact Scale (MFIS) Time: administered at baseline, one month, 6 months, and 12 monthsDescription: 54-item multidimensional health-related quality of life measure that combines both generic and MS-specific items
Measure: Multiple Sclerosis Quality of Life Scale 54 item version Time: administered at baseline, one month, 6 months, and 12 monthsOver half of persons with multiple sclerosis (MS) report falling over a 6-month period and a majority of those who fall require medical attention for injuries. Importantly, balance dysfunction, muscle weakness, and spasticity are modifiable risk factors for falls among community-dwelling older adults and likely persons with MS. Indeed, there is evidence that these physiological risk factors can be minimized with exercise training in persons with MS and this might translate into a decrease in fall risk as documented in community-dwelling older adults. The investigation will examine the effectiveness of a home-based exercise program that is designed to reduce fall risk by targeting specific fall risk factors including balance dysfunction and two of its latent causes, muscle weakness and spasticity in persons with multiple sclerosis. It is predicted that persons who receive home-based exercise program will have a reduction in fall risk.
Mobility will be quantified with performance on timed 25 foot walk (T25W), timed up and go (TUG), Six spot step test, 6 minute walk and the MS walking scale-12.. Balance. --- T25W ---
Description: Physiological fall risk will be determined by the physiological profile assessment which assesses physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function.
Measure: Physiological Fall risk Time: 3 monthsDescription: Mobility will be quantified with performance on timed 25 foot walk (T25W), timed up and go (TUG), Six spot step test, 6 minute walk and the MS walking scale-12.
Measure: Mobility Time: 3 monthsDescription: Balance will be quantified with the Berg Balance scale; self-report of balance impairment (ABC); and force platform metrics (sway range and velocity).
Measure: Balance Time: 3 MonthsDescription: Spasticity will be assessed with the modified ashworth scale.
Measure: Spasticity Time: 3 MonthsFalls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.
Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . --- T25W ---
Description: Physiological fall risk will be determined by the short form of the Physiological Profile Assessment (PPA)(Lord, 2003). The PPA is a standardized test battery which assesses vision (edge contrast sensitivity), lower limb proprioception, strength (knee extension), postural sway, and cognitive function (simple hand reaction time). The outcome of each test will be combined to generate an overall fall risk score
Measure: Physiological Fall Risk Time: 3 MonthsDescription: Specific measures of walking speed, endurance, coordination and self-reported walking function scale will be employed to assess overall mobility of each person. Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.
Measure: Mobility Time: 3 monthsDescription: To assess balance (e.g. postural control), we conducted a clinical assessment To measure balance the Berg Balance Scale (BBS) and self-reports of balance confidence will be used. The BBS is a clinical assessment of balance. Scores on the BBS range from 0-56 with higher scores indicating greater balance. The Activities-Specific Balance Confidence (ABC) scale was used as a measure of balance confidence.
Measure: Balance Time: 3 MonthsSpecific Aims The specific aims of the study are: - Primary Objective: To assess the effect of alemtuzumab on microglial activation in MS patients. The hypothesis is that alemtuzumab reduces microglial activation in MS, which may mediate its effect on reducing conversion of RRMS patients to SPMS, and its effects on cognition, including cognitive fatigue. - Secondary Objective: To determine the time course of effect of alemtuzumab on microglial activation. The hypothesis is that alemtuzumab reduces microglial activation at 6 months after initiation of treatment and this effect persists and is accentuated at 18 years, i.e. after administration of the second course
Non Imaging/Clinical Data The following non-imaging/clinical data will be obtained: Expanded Disability Status Scale (EDSS) Timed 25-feet walk (T25W) MS Functional Composite (MSFC) Minimal Assessment of Cognitive Function Scale in MS (MACFIMS) battery Symbol digit modalities test (SDMT) MSQOL-54 scale (QOL) Modified fatigue Impact Scale (MFIS) Pittsburgh Sleep Quality Index (PSQI) Beck's Depression Inventory (BDI) Center for Epidemiological Studies-Depression Scale (CES-D) Hospital Anxiety and Depression Scale (HADS) --- T25W ---
Description: PET outcome measure change at 18 months from baseline
Measure: PET Uptake/Standardized uptake value ratio (SUVR) change Time: baseline and 18 monthsDescription: PET outcome measure change at 6 months from baseline
Measure: PET Uptake/Standardized uptake value ratio (SUVR) change Time: baseline and 6 monthsDescription: MRI outcome measure change at 18 months from baseline
Measure: T2/FLAIR lesion load change Time: baseline and 18 monthsDescription: MRI outcome measure change at 18 months from baseline
Measure: Whole brain/deep gray matter atrophy change Time: baseline and 18 monthsDescription: Clinical outcome measure change at 18 months from baseline; Scale Range: 0-10; Higher values represent worse outcomes
Measure: Expanded Disability Status Scale (EDSS) change Time: baseline and 18 monthsDescription: Clinical outcome measure change at 18 months from baseline
Measure: Timed 25-foot walk (T25FW) change Time: baseline and 18 monthsDescription: Clinical outcome measure change at 18 months from baseline; Physical subscale range: 0-36; Cognitive subscale range: 0-40; Psychosocial subscale range: 0-8; Total MFIS Score scale range (Subscales Summed): 0-84; Higher values represent worse outcomes
Measure: Modified Fatigue Impact Scale (MIFS) change Time: baseline and 18 monthsDescription: Clinical outcome measure change at 18 months from baseline
Measure: Minimal Assessment of Cognitive Function in MS (MACFIMS) change Time: baseline and 18 monthsThe objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
A higher score reflects a better health state.. Change from Baseline Over Time in the Timed 25-Foot Walk (T25W). --- T25W ---
The T25W is the measurement to assess walking ability. --- T25W ---
Description: The VAS for pain is a subjective measure and it consists of a 100 millimeter (mm) line with two end points representing 'no pain' to 'pain as bad as it could be'. Participants are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.
Measure: Change from Baseline to Week 24 in the Visual Analogue Scale (VAS) Score for Pain Time: Baseline, Week 24Description: FACIT fatigue scale includes 13 statements, which measures fatigue/asthenia for participants with chronic, life-threatening illnesses. For each question, a participant rates his/her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). A score is calculated by averaging the individual question scores, with lower scores indicative of less fatigue.
Measure: Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Time: Baseline, Week 24Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the Short Form Generic Health Survey (SF-36) Bodily Pain Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 General Health Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Mental Health Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Physical Functioning Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Role-Emotional Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Role-Physical Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Social Role Functioning Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Vitality Domain Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Mental Component Summary Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The SF-36 domain scores range from 0-100. Higher scores indicate better quality of life.
Measure: Change from Baseline Over Time in the SF-36 Physical Component Summary Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state.
Measure: Change from Baseline Over Time in the EuroQoL-5 Dimensions (EQ-5D) Index Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The T25W is the measurement to assess walking ability. The time (in seconds) that it takes the participant to walk 25 feet is measured.
Measure: Change from Baseline Over Time in the Timed 25-Foot Walk (T25W) Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The mRS is a 7-point disability scale that assesses the degree of disability in patients with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability.
Measure: Change from Baseline Over Time in Modified Rankin Scale (mRS) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden.
Measure: Change from Baseline Over Time in Zarit Burden Interview (ZBI) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)Description: The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measure: Change from Baseline Over Time in Expanded Disability Status Scale (EDSS) Score Time: Baseline and every 24 weeks thereafter until 12 weeks after last dose of satralizumab (up to approximately 6.75 years)