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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 79
Updated:4/17/2018
Start Date:May 2013
End Date:February 2016

Use our guide to learn which trials are right for you!

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Clozapine, olanzapine (and there is no intent to initiate therapy during the
course of the study)

- Carbamazepine, primidone

- Drugs for which there is a warning or precaution in the labeling about
methemoglobinemia at approved doses

- Current or prior participation in a clinical trial as follows:

- Clinical trial of a product for cognition within 3 months of Screening (unless
confirmed to have been randomized to placebo)

- A clinical trial of a drug, biologic, device, or medical food in which the last
dose/administration was received within 28 days prior to Baseline
We found this trial at
25
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bennington, Vermont 05201
?
mi
from
Bennington, VT
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brooklyn, New York 11229
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Randwick, New South Wales 2031
?
mi
from
Randwick,
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94158
?
mi
from
San Francisco, CA
Click here to add this to my saved trials