Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
NCT ID: NCT02245568
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
913 participants
INTERVENTIONAL
2014-08-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LMTM
LMTM
The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Interventions
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LMTM
The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Eligibility Criteria
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Inclusion Criteria
* Subjects with a diagnosis of probable bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
* Females, if of child-bearing potential, must practice true abstinence or continue to use adequate contraception and agree to maintain this throughout the study
* Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent
* Has an identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
* Able to comply with the study procedures
Exclusion Criteria
* Pregnant or breastfeeding
* Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
* Current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food
* In Germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced
ALL
No
Sponsors
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TauRx Therapeutics Ltd
INDUSTRY
Responsible Party
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Locations
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Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States
Southern California Research, LLC
Fountain Valley, California, United States
Feldman, Robert MD
Laguna Hills, California, United States
Collaborative Neuroscience Network
Long Beach, California, United States
The Shankle Clinic
Newport Beach, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Pacific Research Network
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Memory and Aging Centre
San Francisco, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Mile High Research Center
Denver, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
JEM Research
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
CNS Healthcare, Inc
Jacksonville, Florida, United States
Miami Research Associates
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
The Roskamp Institute, Inc.
Sarasota, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Compass Research, LLC - North Clinic
The Villages, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Neurostudies.net
Decatur, Georgia, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
Mayo Clinic, Alzheimer's Disease Research Center
Rochester, Minnesota, United States
Neurological Research Center - Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States
Memory Enhancement Center of America, Inc
Eatontown, New Jersey, United States
The Atlantic Neuroscience Institute
Springfield, New Jersey, United States
Advanced Memory Research Institute of NJ PC
Toms River, New Jersey, United States
Neurological Associates of Albany, P. C.
Albany, New York, United States
SPRI
Brooklyn, New York, United States
Columbia University Taub Institute
New York, New York, United States
Research Foundation for Mental Hygiene, Inc.
Orangeburg, New York, United States
UNC Department of Neurology, Physicians Office Building
Chapel Hill, North Carolina, United States
Clinical Trials of America, Inc
Winston-Salem, North Carolina, United States
Neurobehavioral Clinical Research
Canton, Ohio, United States
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland, Ohio, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, United States
RI Hospital
Providence, Rhode Island, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Clinical Neuroscience Solutions CNS Healthcare
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Senior Adults Specialty Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
University of Virginia Adult Neurology, Primary Care Center
Charlottesville, Virginia, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States
Frontotemporal Research Group
Camperdown, New South Wales, Australia
Division of Rehabilitation and Aged Care
Hornsby, New South Wales, Australia
Southern Neurology Pty Limited
Kogarah, New South Wales, Australia
Discipline of Psychiatry, University of Queensland
Herston, Queensland, Australia
Royal Adelaide Hospital Memory Trials Centre
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia
McCusker Alzheimer's Research Foundation Inc
Nedlands, Western Australia, Australia
Neurodegenerative Disorders Research Pty Ltd
Subiaco, Western Australia, Australia
University Hospital Ghent Department of Neurology
Ghent, , Belgium
Jessa Hospital
Hasselt, , Belgium
GZA Sint-Augustinus
Wilrijk, , Belgium
Heritage Medical Research Clinic
Calgary, Alberta, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, Canada
Vancouver Island Health Authority
Victoria, British Columbia, Canada
True North Clinical Research Halifax Inc
Halifax, Nova Scotia, Canada
True North Clinical Research Kentville Inc
Kentville, Nova Scotia, Canada
Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site
London, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun, Quebec, Canada
University Hospital Centre Zagreb, Department of Neurology
Zagreb, , Croatia
University Psychiatric Hospital Vrapče
Zagreb, , Croatia
University of Eastern Finland, Brain Research Unit Mediteknia
Kuopio, , Finland
Clinical Research Services Turku (CRST)
Turku, , Finland
Hôpitaux Civils de Colmar
Colmar, Cedex, France
Centre de Recherche Clinique
Toulouse, , France
Hôpital de Charpennes
Villeurbanne, , France
Charité, University Medicine Berlin, CBF, Neurology
Berlin, , Germany
Arzeneimittelforschung Leipzig GmbH
Leipzig, , Germany
University Kuala Lumpur Royal College of Medicine
Ipoh, , Malaysia
Hospital Sultan Ismail
Johor Bahru, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Erasmus University Medical Center
Rotterdam, , Netherlands
Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III
Sibiu, , Romania
Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"
Moscow, , Russia
Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department
Moscow, , Russia
Mental Health Research Center of the Russian Academy of Medical Sciences
Moscow, , Russia
City Clinical Hospital #34, City Scientific Practical Neurological Center
Novosibirsk, , Russia
City Geriatric Medical and Social Center
Saint Petersburg, , Russia
Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev
Saint Petersburg, , Russia
State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"
Yekaterinburg, , Russia
National University Hospital (NUH)
Singapore, , Singapore
National Neuroscience Institute (NNI)
Singapore, , Singapore
Dong-A University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Fundació ACE
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Viamed Montecanal
Zaragoza, , Spain
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Grampian NHS, Royal Cornhill Hospital
Aberdeen, , United Kingdom
RICE - The Research Institute for the Care of Older People
Bath, , United Kingdom
Belfast Health and Social Care Trust (BHSCT)
Belfast, , United Kingdom
The Barberry Centre
Birmingham, , United Kingdom
MAC Clinical Research Ltd
Blackpool, , United Kingdom
MAC Clinical Research Ltd
Cannock, , United Kingdom
Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit
Crowborough, , United Kingdom
St Margaret's Hospital Mental Health Unit
Epping, , United Kingdom
Cognition Health Ltd
Guildford, , United Kingdom
MAC Clinical Research Ltd
Leeds, , United Kingdom
Cognition Health Ltd.
London, , United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, , United Kingdom
Leonard Wolfson Experimental Neurology Centre
London, , United Kingdom
MAC Clinical Research Ltd
Manchester, , United Kingdom
Nuffield Department of Clinical Neurosciences
Oxford, , United Kingdom
Redwoods Centre
Shrewsbury, , United Kingdom
Wessex Neurological Centre, Southampton General Hospital
Southampton, , United Kingdom
Memory Assessment and Research Centre (MARC)
Southampton, , United Kingdom
Kingshill Research Centre, Victoria Hospital
Swindon, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TRx-237-020
Identifier Type: -
Identifier Source: org_study_id
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