TRIALS FUNDED BY NATIONAL MS SOCIETY Updated September 2014 Abbreviations Key: AAN – American Academy of Neurology ECTRIMS – European Committee of Treatment and Research in MS IM – intramuscular, injected into muscle IV – intravenous, injected into vein PP - primary progressive PR - progressive relapsing RR - relapsing-remitting SC – subcutaneous, injected under the skin SP - secondary progressive AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY Aspirin Restore improve fatigue Dean M. Wingerchuk Mayo Clinic, RR, SP/135 Scottsdale, AZ Terminated due to unfavorable interim analysis and slow recruitment, read more: http://clinicaltrials.gov/show/NCT00467584 . be safe and tolerable David Wraith Apitope Technology (Bristol), Ltd. Completed, read more: http://www.nationalmssociety.org/About-theSociety/News/Apitope-Announces-Successful; phase 2 underway, read more: http://clinicaltrials.gov/show/NCT01973491 ATX-MS-1467 Stop TYPE OF MS/NUMBER OF SUBJECTS Relapsing/ 40 STATUS/RESULTS AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS AVACore® (cooling device) Restore improve fatigue, ambulation, and cognition Barbara S. Giesser University of California, Los Angeles All types/30 Recruiting, read more: http://www.nationalmssociety.org/Research/Pa rticipate-in-Research-Studies/Participate-inClinical-Trials/Clinical-Trials/Clinical-TrialEstriol Axona® (caprylic triglyceride) Restore improve cognitive function University of Miami; Accera, Inc. All types/158 Recruiting, read more http://clinicaltrials.gov/show/NCT01848327. Estriol + glatiramer acetate (Copaxone®, Teva Pharm. Industries, Ltd.) Stop control disease course Melissa R. Ortega and Heather Katzen Rhonda R. Voskuhl University of California, Los Angeles RR (women)/ 130 Completed; in preliminary results, no statistical difference in primary endpoint, read more: http://www.nationalmssociety.org/About-theSociety/News/Preliminary-Results-from-Phase2-Clinical-Trial-of Helminthinduced immunemodulation therapy Stop be safe and effective in reducing disease activity (also known as HINT 1 Study) John Fleming University of Wisconsin, Madison RR/20 Completed; number of active brain lesions moderately reduced compared to the beginning of the trial, some evidence that treatment could promote activity of diseasesuppressing white blood cells (Abstract P3.149, AAN 2014, read more http://www.abstracts2view.com/aan/view.php? nu=AAN14L1_P3.149) AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Ibudilast Stop Robert Fox Cleveland Clinic Foundation, OH SP, PP/250 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01982942 Lipoic acid Restore to protect nervous system and stop progression relieve optic nerve injury Vijayshree Yadav Optic neuritis/54 Recruiting, read more here http://clinicaltrials.gov/ct2/show/NCT01294176. Lipoic Acid and Omega-3 Fatty Acids Restore to improve cognitive function Lynne Shinto RR, SP/53 Not yet recruiting, read more: http://clinicaltrials.gov/show/NCT02133664. Meditation Restore to improve emotional function slow or stop MS progression Ruchika Prakash Oregon Health & Science University, Portland Oregon Health & Science University, Portland Ohio State University, Columbus RR/24 Ongoing, no further information available. MS Clinical Trials Network established by the MS Society in the United Kingdom London, UK SP/350 Not yet recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01910259. prevent optic nerve injury Raju Kapoor University College, London, UK Optic neuritis/90 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01451593. MS SMART Stop (three therapies with nerveprotecting potential: Ibudilast, Amiloride, and Riluzole) Phenytoin Stop AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Rehabilitation Restore improve cognitive function Barbara S. Giesser All types/50 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01219647. Restore improve cognitive function Charles Bombardier University of California, Los Angeles University of All types/125 Recruiting, read more: http://clinicaltrials.gov/show/NCT02106052. RR, SP/20 Recruiting, read more, http://clinicaltrials.gov/show/NCT01783665. All types/12 Ongoing, no further information available. Brown Relapsing/ University, 10 Providence University All types/88 of Colorado, Denver Ongoing, no further information available. (aerobic exercise) Rehabilitation (aerobic exercise) Rehabilitation Restore (aerobic exercise) Rehabilitation Restore (anticipatory postural control) Rehabilitation Restore (backwards walking) Rehabilitation Restore (balance and eye movement exercises) Rehabilitation (computerized Cognitive Exercise Training) Restore Washington, improve cognitive function and sleep quality improve balance Catherine Siengsukon improve gait problems Improve stability and reduce fatigue improve cognitive function Albert Lo Alexander Aruin Jeffrey Hebert Lauren Krupp Seattle University of Kansas Medical Center, Kansas City University of Illinois at Chicago State University of New York, Stony Brook All types/136 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01698086. Recruiting, read more: http://clinicaltrials.gov/show/NCT02141386. AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Rehabilitation (constraintinduced movement therapy) Restore Rehabilitate extremity use Victor Mark University of Alabama at Birmingham SP, PP/66 Completed; use of the weaker arm improved, and brain tissue in the cortex (the outer layer of the brain) increased significantly, read more here: http://www.nationalmssociety.org/Aboutthe-Society/News/Emerging-Therapies,Wellness,-Progression-and-Othe (Restrain an arm, rebuild the brain) Rehabilitation (dance intervention) Rehabilitation (dual task rehabilitation) Restore Albert Lo Brown University, Providence University of Illinois at UrbanaChampaign All types/70 Ongoing, no further information available. Restore With significant mobility impairment/ 30 RR/50 Ongoing, no further information available. Rehabilitation (internetbased program to increase physical activity) increase physical activity imrpove walking and cognitive function increase physical activity Restore Jacob Sosnoff Robert Motl University of Illinois at UrbanaChampaign Completed; significant improvements in increasing physical activity, and reducing fatigue, depression and anxiety (Abstract #SX23, CMSC 2013) and improvements in bone health and body composition among the video-chatting group as well as improvements in cognitive function in those with mild disability (Abstract #RH24, #CG12, CMSC 2014). AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Rehabilitation (iPad-based program of intellectually engaging and enriching activities) Rehabilitation (leg cycling) Restore improve cognitive function Victoria Leavitt Kessler Foundation Research Center, West Orange, NJ All types/16 Ongoing, no further information available. Restore reduce spasticity Jacob Sosnoff All types/30 Ongoing, no further information available. Rehabilitation (lung volume recruitment) Rehabilitation (manualized cognitive rehabilitation program) Restore All types/69 Recruiting, read more http://clinicaltrials.gov/show/NCT01891071. All types/20 Ongoing, no further information available. Rehabilitation (multi-modal exercise program) Restore All types/40 Ongoing, no further information available. Rehabilitation (progressive resistance training) Restore All types/60 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01632293. Restore University of Illinois at UrbanaChampaign improve Nadim Srour University respiratory of Ottawa, function Ontario, CA improve Michael Basso University memory of Tulsa, and the OK ability to perform activities reduce Robert Motl University progressi of Illinois at on of Urbanamobility Champaign disability predict Kathleen Johns improve Zackowski Hopkins ment in University functional School of moveme Medicine, nt Baltimore, MD AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Rehabilitation (selfgenerated treatment protocol) Restore to improve memory Yael Goverover All types/40 Recruiting, read more: http://clinicaltrials.gov/show/NCT02032589. Rehabilitation (speed of processing training) Restore improve cognitive function Nancy Chiaravalloti All types/20 Recruiting, read more here http://clinicaltrials.gov/show/NCT01838824. Rehabilitation Restore (stylistic memory enhancement) improve learning and memory Nancy Chiaravalloti All types/30 Ongoing, no further information available. Rehabilitation (talk therapy intervention) protocol) Stop improve treatment Jared Bruce Kessler Foundation Research Center, West Orange, NJ Kessler Foundation Research Center, West Orange, NJ Kessler Foundation Research Center, West Orange, NJ University of Missouri, Kansas City RR/60 Recruiting, read more: http://clinicaltrials.gov/show/NCT0192569. Rehabilitation (telehealth selfmanagement Intervention) Restore Matthew Plow Cleveland Clinic Foundation, OH All types/215 Recruiting, read more http://clinicaltrials.gov/show/NCT01572714. Rehabilitation (virtual reality intervention) Restore Alon Kalron Sheba RR/30 Medical Center, Ramat Gan, Israel adherence manage fatigue and increase physical activity to improve balance Ongoing, no further information available. AGENT RESEARCH STRATEGY PURPOSE OF STUDY INVESTIGATOR UNIVERSITY/ COMPANY TYPE OF MS/NUMBER OF SUBJECTS STATUS/RESULTS Rehabilitation (working memory training) Restore to improve memory Janet Shucard RR/24 Ongoing, no further information available. Vitamin D + glatiramer acetate (Copaxone®, Teva Pharm. Industries, Ltd.) Stop be safe and effective in reducing disease activity Ellen M. Mowry State University of New York, Buffalo Johns Hopkins University School of Medicine, Baltimore, MD RR/172 Recruiting, read more http://clinicaltrials.gov/ct2/show/NCT01490502.
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