Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
1 other identifier
interventional
220
12 countries
67
Brief Summary
The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2013
Typical duration for phase_3
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 14, 2018
March 1, 2018
2.8 years
June 20, 2012
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)
52 weeks
Change from Baseline on Functional Activities Questionnaire (FAQ)
52 weeks
Change from Baseline on whole brain volume (assessed by brain MRI)
52 weeks
Secondary Outcomes (4)
Change from Baseline on Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III)
52 weeks
Change from Baseline on Frontotemporal Dementia Rating Scale (FRS)
52 weeks
Change from Baseline on Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (modified ADCS-CGIC)
52 weeks
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
52 weeks
Other Outcomes (5)
Early effect on modified ADCS-CGIC (change from Baseline)
8 weeks
Change from Baseline on the rate of atrophy in frontal and temporal lobes as well as ventricular volume (assessed by brain MRI)
52 weeks
Change from Baseline on Mini-Mental Status Examination (MMSE)
52 weeks
- +2 more other outcomes
Study Arms (2)
TRx0237 200 mg/day group
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Placebo tablets will be administered twice daily. The placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.
Eligibility Criteria
You may qualify if:
- Diagnosis of probable bvFTD
- Centrally rated frontotemporal atrophy score of 2 or greater on brain MRI
- MMSE ≥20
- Age \<80 years
- Modified Hachinski ischemic score of ≤ 4
- Females, if of child-bearing potential, must practice true abstinence or be competent 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 is/are able to read, understand, and provide written informed consent
- Has one (or more) 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 ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
- If currently taking an acetylcholinesterase inhibitor and/or memantine, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
- Able to comply with the study procedures
You may not qualify if:
- Significant central nervous system (CNS) disorder other than bvFTD
- Significant intracranial pathology seen on brain MRI scan
- Biomarker evidence of underlying Alzheimer's disease pathology
- Expressive language deficits
- Meets research criteria for Amyotrophic Lateral Sclerosis or motor neuron disease
- Meets diagnostic criteria for probable bvFTD but has a proven mutation producing non-tau, non-TDP-43 pathology
- Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
- Epilepsy
- Rapid eye movement sleep behavior disorder
- Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
- Resides in hospital or moderate to high dependency continuous care facility
- History of swallowing difficulties
- Pregnant or breastfeeding
- Glucose-6-phosphate dehydrogenase deficiency
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
David Geffen School of Medicine at UCLA, UCLA Neurological Services
Los Angeles, California, 90095, United States
The Shankle Clinic
Newport Beach, California, 92663, United States
Memory and Aging Centre
San Francisco, California, 94158, United States
Meridien Research
Brooksville, Florida, 34601, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33613, United States
Department of Neurology, Emory University
Atlanta, Georgia, 30329, United States
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, 60007, United States
Indiana University Department of Neurology
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Neurological Clinical Research Institute (NCRI) Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic, Department of Neurology
Rochester, Minnesota, 55905, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Neurological Associates of Albany, P. C.
Albany, New York, 12208, United States
Integrative Clinical Trials LLC
Brooklyn, New York, 11229, United States
UNC Department of Neurology, Physicians Office Building
Chapel Hill, North Carolina, 27599, United States
University Hospitals Case Medical Center, Neurology Clinical Trials Unit
Cleveland, Ohio, 44106, United States
Rivers Wellness and Research Institute
Oklahoma City, Oklahoma, 73112, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Hospital of the University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, 19104, United States
PRA Health Sciences, Phase 2/3 Outpatient and CNS Clinic
Salt Lake City, Utah, 84106, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Neuroscience Research Australia
Randwick, New South Wales, 2031, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Neurodegenerative Disorders Research Pty Ltd
West Perth, Western Australia, 6005, Australia
Heritage Medical Research Clinic-University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders
Vancouver, British Columbia, V6T 2B5, Canada
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8, Canada
True North Clinical Research
Halifax, Nova Scotia, B3S 1M7, Canada
Geriatric Clinical Trials Group, Parkwood Institute
London, Ontario, N6C 0A7, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
University Health Network, Toronto Western Hospital, Memory Clinic
Toronto, Ontario, M5T 2S8, Canada
McGill Centre for Studies in Aging, Alzheimer Disease Research Unit
Verdun, Quebec, H4H 1R3, Canada
University Hospital Centre Zagreb
Zagreb, 10000, Croatia
University Psychiatric Hospital Vrapče
Zagreb, 10090, Croatia
Charité-Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie
Berlin, 10117, Germany
Memory Clinic, ECRC
Berlin, 13125, Germany
Universitätsklinikum Hamburg-Eppendorf Klinik für Psychiatrie und Psychotherapie
Hamburg, 20246, Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Technischen Universität München
München, 81675, Germany
Universitäts - und Rehabilitationskliniken Ulm, Neurologie
Ulm, 89081, Germany
Unità di Neuroimmagine e Epidemiologia Alzheimer
Brescia, 25125, Italy
Fondazione Universita' Gabriele D'Annunzio di Chieti
Chieti Scalo, 66100, Italy
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan, 20133, Italy
Neurology I, Department of Neuroscience, University of Torino
Torino, 10126, Italy
Jeroen Bosch Ziekenhuis, afdeling geriatrie
's-Hertogenbosch, 5223, Netherlands
Alzheimer Research Center Amsterdam
Amsterdam, 1081, Netherlands
Erasmus University Medical Center
Rotterdam, 3015, Netherlands
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska
Poznan, 61-853, Poland
Euromedis Sp. z o.o.
Szczecin, 70-111, Poland
Psychomedical Consult
Bucharest, 024072, Romania
National Neuroscience Institute Department of Neurology
Singapore, 308433, Singapore
Fundació ACE. Institut Català de Neurociències Aplicades
Barcelona, 08028, Spain
Ceuta University Hospital; Neurology
Ceuta, 51003, Spain
Hospital Viamed Montecanal, Neurology Department
Zaragoza, 50012, Spain
NHS Grampian, OAP Directorate
Aberdeen, AB25 2ZH, United Kingdom
The Barberry Out-Patients Department
Birmingham, B15 2FG, United Kingdom
2gether NHS foundation trust
Cheltenham, GL53 9DZ, United Kingdom
Kingsway Hospital
Derby, DE22 3LZ, United Kingdom
St Margaret's Hospital Mental Health Unit
Epping, CM16 6TN, United Kingdom
Cognition Health Ltd.
London, W1G 9JF, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF, United Kingdom
Dementia Research Center at Queens Square
London, WC1N 3BG, United Kingdom
Nuffield Department of Clinical Neurosciences
Oxford, OX3 9DU, United Kingdom
Redwoods Centre
Shrewsbury, SY3 5DS, United Kingdom
Wessex Neurological Centre, Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Pletnikova O, Sloane KL, Renton AE, Traynor BJ, Crain BJ, Reid T, Zu T, Ranum LP, Troncoso JC, Rabins PV, Onyike CU. Hippocampal sclerosis dementia with the C9ORF72 hexanucleotide repeat expansion. Neurobiol Aging. 2014 Oct;35(10):2419.e17-21. doi: 10.1016/j.neurobiolaging.2014.04.009. Epub 2014 Apr 18.
PMID: 24819148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2012
First Posted
June 22, 2012
Study Start
May 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 14, 2018
Record last verified: 2018-03