Abstract:
BACKGROUND:Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal biomarkers for phase II PMS trials is unknown. Ibudilast is an inhibitor of macrophage migration inhibitor factor and phosphodiesterases-4 and -10 and exhibits possible neuroprotective properties. The goals of SPRINT-MS study are to evaluate the safety and efficacy of ibudilast in PMS and to directly compare several imaging metrics for utility in PMS trials. METHODS:SPRINT-MS is a randomized, placebo-controlled, phase II trial of ibudilast in patients with PMS. Eligible subjects were randomized 1:1 to receive either ibudilast (100mg/day) or placebo for 96weeks. Imaging is conducted every 24weeks for whole brain atrophy, magnetization transfer ratio, diffusion tensor imaging, cortical brain atrophy, and retinal nerve fiber layer thickness. Clinical outcomes include neurologic disability and patient reported quality of life. Safety assessments include laboratory testing, electrocardiography, and suicidality screening. RESULTS:A total of 331 subjects were enrolled, of which 255 were randomized onto active study treatment. Randomized subjects were 53.7% female and mean age 55.7 (SD 7.3) years. The last subject is projected to complete the study in May 2017. CONCLUSION:SPRINT-MS is designed to evaluate the safety and efficacy of ibudilast as a treatment for PMS while simultaneously validating five different imaging biomarkers as outcome metrics for use in future phase II proof-of-concept PMS trials.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Fox RJ,Coffey CS,Cudkowicz ME,Gleason T,Goodman A,Klawiter EC,Matsuda K,McGovern M,Conwit R,Naismith R,Ashokkumar A,Bermel R,Ecklund D,Koepp M,Long J,Natarajan S,Ramachandran S,Skaramagas T,Thornell B,Yankey J,Agidoi
10.1016/j.cct.2016.08.009subject
Has Abstractpub_date
2016-09-01 00:00:00pages
166-77eissn
1551-7144issn
1559-2030pii
S1551-7144(16)30207-5journal_volume
50pub_type
杂志文章,随机对照试验abstract::The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106218
更新日期:2020-11-14 00:00:00
abstract:BACKGROUND:Low back pain (LBP) is one of the most common reasons for seeking medical care. Manipulative therapies are a common treatment for LBP. Few studies have compared the effectiveness of different types of manipulative therapies. Moreover, the physiologic mechanisms underlying these treatments are not fully under...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.05.012
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.001
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abstract::Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.03.004
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abstract:BACKGROUND:Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2012.10.005
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abstract::Establishing a holistic approach for the enrollment of subjects into clinical trials that includes strategies for the recruitment of non-traditional and minority populations has been an elusive task. The existence of such a design, that is understood and embraced by investigators and the target communities, would stre...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.11.003
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abstract::First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interv...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.07.020
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.12.021
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.11.019
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2004.11.020
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abstract::Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., b...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.08.013
更新日期:2013-11-01 00:00:00
abstract:BACKGROUND:Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. METHODS: EXPOSURE:Randomization to cin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.04.001
更新日期:2016-05-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.06.002
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abstract::The Flexibility, Toning, and Balance (FlexToBa) Trial is a two-armed randomized controlled trial which will contrast the effects of a DVD-delivered, home-based, physical activity intervention and a Healthy Aging attention control condition on physical activity, functional performance, functional limitations, and quali...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.10.002
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.09.004
更新日期:2017-11-01 00:00:00
abstract:BACKGROUND:Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evid...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2021.106267
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.06.011
更新日期:2017-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2013.06.005
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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abstract::Slow or insufficient enrollment in clinical research and a high demand for research participants raises questions about the need for and use of incentives to participate, including payment. Much of the available literature on payment to research participants focuses on ethical concerns, and rarely addresses guidelines...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.05.001
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.05.008
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.05.002
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106053
更新日期:2020-08-01 00:00:00
abstract:BACKGROUND:Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and die...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.09.004
更新日期:2013-01-01 00:00:00
abstract::Hepatitis C virus (HCV) is a leading cause of chronic liver disease. The natural history of HCV infection is heterogeneous, and a person infected with HCV can clear the virus or progress to a chronic infection. The chronic infection can remain asymptomatic for decades before the development of liver cirrhosis and/or c...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2008.03.006
更新日期:2008-09-01 00:00:00
abstract::The prevalence of type 2 diabetes continues to increase in minority and underserved patients, who are also more likely to have poorer control of diabetes and related risk factors for complications. Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients w...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.12.005
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.03.014
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:Anxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs. METHODS:Presen...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.05.002
更新日期:2012-09-01 00:00:00
abstract::The convention in clinical trials is to regard outcomes as independently distributed, possibly conditional on covariates, but in some situations they may be correlated. For example, in infectious diseases, correlation may be induced if participants have contact with a common infectious source, or share hygienic tips t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.08.001
更新日期:2014-09-01 00:00:00