Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Behavioral Variant Frontotemporal Dementia (bvFTD)

In brief

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).

Key facts

Study ID

NCT01626378

Run by

TauRx Therapeutics Ltd

People needed

220

Starts

2013-05-01

Expected to finish

2016-02-01

Last updated by the study team

2018-03-14

Who can join

Age: any, up to 79. Sex: any. Healthy volunteers: not accepted.

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
• History of significant hematological abnormality or current acute or chronic clinically significant abnormality
• Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
• Clinically significant cardiovascular disease or abnormal assessments
• Preexisting or current signs or symptoms of respiratory failure
• Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than bvFTD
• Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
• Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
• Treatment currently or within 90 days before Baseline with any of the following medications (unless otherwise noted):
• Tacrine
• Amphetamine or dexamphetamine

Where it is running

• The Shankle Clinic — Newport Beach, California, United States
• Memory and Aging Centre — San Francisco, California, United States
• Meridien Research — Brooksville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Department of Neurology, Emory University — Atlanta, Georgia, United States
• Alexian Brothers Neurosciences Institute Clinical Research — Elk Grove Village, Illinois, United States
• Indiana University Department of Neurology — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Neurological Clinical Research Institute (NCRI) Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic, Department of Neurology — Rochester, Minnesota, United States
• Memory Enhancement Center of America, Inc. — Eatontown, New Jersey, United States
• Neurological Associates of Albany, P. C. — Albany, New York, United States
• Integrative Clinical Trials LLC — Brooklyn, New York, United States
• UNC Department of Neurology, Physicians Office Building — Chapel Hill, North Carolina, United States
• University Hospitals Case Medical Center, Neurology Clinical Trials Unit — Cleveland, Ohio, United States
• Rivers 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
• PRA Health Sciences, Phase 2/3 Outpatient and CNS Clinic — Salt Lake City, Utah, United States
• The Memory Clinic — Bennington, Vermont, United States
• University of Virginia — Charlottesville, Virginia, United States
• Neuroscience Research Australia — Randwick, New South Wales, Australia
• David Geffen School of Medicine at UCLA, UCLA Neurological Services — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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