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Multiple Sclerosis clinical trials at UCSF

22 in progress, 7 open to eligible people

Showing trials for
  • Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

    open to eligible females ages 40-65

    The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple sclerosis (RRMS). The investigators will utilize electrophysiologic techniques and magnetic resonance imaging to quantify the effect of treatment in 50 women over the course of 6 months. Participants may remain on their standard disease modifying treatment during the course of the trial but may not concurrently participate in any other investigational new drug research study.

    San Francisco, California

  • Computerized Cognitive Training in MS

    open to eligible people ages 18-60

    WHO: 40 participants with a confirmed diagnosis of Multiple Sclerosis (MS) able to engage in moderate physical activity. WHY: The purpose of this study is to evaluate two computerized brain training tools, which include light physical activity, to see if they can help improve cognitive functions, such as memory and attention, for patients with MS. WHAT: Complete a set of tests (physical and cognitive) at baseline, wear a Fitbit Flex device at home for the duration of the study, 3 supervised sessions for 4 weeks at UCSF, one visit for physical and cognitive tests at one week after the final supervised session, and one final visit 6 months after the final supervised session. WHERE: 20 participants at the UCSF Weill Institute for Neurosciences (675 Nelson Rising Lane, San Francisco, CA); 20 participants at Lausanne University Hospital (Rue du Bugnon 46, 1005 Lausanne, Switzerland)

    San Francisco, California and other locations

  • ECoG BMI for Motor and Speech Control

    open to eligible people ages 21 years and up

    Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

    San Francisco, California

  • Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis

    open to eligible people ages 18-60

    In this Phase 1b open-label prospective clinical trial, patients with relapsing-remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points. The active phase of the study will continue for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures. The study duration for the Observational Control Arm is 12 weeks.

    San Francisco, California

  • Melatonin for Sleep in MS

    open to eligible people ages 20-70

    Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration. To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.

    San Francisco, California

  • Ocrelizumab in Breastmilk

    open to eligible females ages 18-64

    The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infections) in their offspring. This study will fill a significant unmet need as many women with MS at high risk for postpartum relapses are not effectively treated for their MS in the postpartum period due to lack of information about the presence, concentration and effects of medications in breastmilk.

    San Francisco, California

  • Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

    open to eligible people ages 18-60

    FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

    San Francisco, California and other locations

  • A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

    San Francisco, California and other locations

  • A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

    Sorry, not currently recruiting here

    This 2-year study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages >/= 10 to < 18 years with relapsing-remitting multiple sclerosis (RRMS). The first 24-week period will serve to determine the dose of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

    San Francisco, California and other locations

  • A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

    San Francisco, California and other locations

  • A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

    San Francisco, California and other locations

  • A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

    San Francisco, California and other locations

  • A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with progressive Multiple Sclerosis (PMS).

    San Francisco, California and other locations

  • A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety and efficacy of elezanumab in subjects with relapsing Multiple Sclerosis (RMS).

    San Francisco, California and other locations

  • A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

    San Francisco, California and other locations

  • A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

    Sorry, not yet accepting patients

    This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.

    San Francisco, California and other locations

  • Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

    Sorry, not yet accepting patients

    The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.

    San Francisco, California and other locations

  • Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)

    Sorry, in progress, not accepting new patients

    The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

    San Francisco, California and other locations

  • Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

    Sorry, not yet accepting patients

    Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.

    San Francisco, California

  • Non-invasive Transcranial Electrical Stimulation in MS

    Sorry, not yet accepting patients

    The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.

    San Francisco, California

  • Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

    Sorry, in progress, not accepting new patients

    This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 [control group]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab, to be administered every 6 months starting at Week 72 for up to 4 years.

    San Francisco, California and other locations

  • Vitamin D Supplementation in Multiple Sclerosis

    Sorry, in progress, not accepting new patients

    Low vitamin D levels have been shown to increase a person's risk of developing multiple sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of having attacks. However, it is not known if giving supplemental vitamin D to those with MS reduces the risk of attacks, and some research suggests that vitamin D could even be harmful to people with MS. In this clinical trial, patients with relapsing-remitting MS will receive high-dose or low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate. Patients will be evaluated for two years, and the effect of high-dose vitamin D supplementation on the rate of MS attacks and on the number of new lesions and change in brain volume on MRI will be determined. Establishing this association will have major implications for the treatment of individuals with MS throughout the world.

    San Francisco, California and other locations

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