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Behavioral Variant Frontotemporal Dementia (bvFTD)Phase 3NCT01626378

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

A Phase 3 study testing TRx0237 in people with Behavioral Variant Frontotemporal Dementia (bvFTD), run by TauRx Therapeutics Ltd at 67 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages Up to 79 years
What is being tested?
TRx0237
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
67 sitesin 12 countries
Study dates
May 2013to Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 79 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

67 sites in 12 countries.

67 sites in 12 countries

United States24 sites

  • Neurological Associates of Albany, P. C.

    Albany, New York, 12208

  • Department of Neurology, Emory University

    Atlanta, Georgia, 30329

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Neurological Clinical Research Institute (NCRI) Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229

  • Meridien Research

    Brooksville, Florida, 34601

  • UNC Department of Neurology, Physicians Office Building

    Chapel Hill, North Carolina, 27599

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University Hospitals Case Medical Center, Neurology Clinical Trials Unit

    Cleveland, Ohio, 44106

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Indiana University Department of Neurology

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • David Geffen School of Medicine at UCLA, UCLA Neurological Services

    Los Angeles, California, 90095

  • The Shankle Clinic

    Newport Beach, California, 92663

  • Rivers Wellness and Research Institute

    Oklahoma City, Oklahoma, 73112

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania, Department of Neurology

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic, Department of Neurology

    Rochester, Minnesota, 55905

  • PRA Health Sciences, Phase 2/3 Outpatient and CNS Clinic

    Salt Lake City, Utah, 84106

  • Memory and Aging Centre

    San Francisco, California, 94158

  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

United Kingdom11 sites

  • NHS Grampian, OAP Directorate

    Aberdeen, AB25 2ZH

  • The Barberry Out-Patients Department

    Birmingham, B15 2FG

  • 2gether NHS foundation trust

    Cheltenham, GL53 9DZ

  • Kingsway Hospital

    Derby, DE22 3LZ

  • St Margaret's Hospital Mental Health Unit

    Epping, CM16 6TN

  • Cognition Health Ltd.

    London, W1G 9JF

  • Imperial College Healthcare NHS Trust - Charing Cross Hospital

    London, W6 8RF

  • Dementia Research Center at Queens Square

    London, WC1N 3BG

  • Nuffield Department of Clinical Neurosciences

    Oxford, OX3 9DU

  • Redwoods Centre

    Shrewsbury, SY3 5DS

  • Wessex Neurological Centre, Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Canada8 sites

  • Heritage Medical Research Clinic-University of Calgary

    Calgary, Alberta, T2N 4Z6

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1M7

  • Geriatric Clinical Trials Group, Parkwood Institute

    London, Ontario, N6C 0A7

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • University Health Network, Toronto Western Hospital, Memory Clinic

    Toronto, Ontario, M5T 2S8

  • University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders

    Vancouver, British Columbia, V6T 2B5

  • McGill Centre for Studies in Aging, Alzheimer Disease Research Unit

    Verdun, Quebec, H4H 1R3

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Germany5 sites

  • Charité-Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie

    Berlin, 10117

  • Memory Clinic, ECRC

    Berlin, 13125

  • Universitätsklinikum Hamburg-Eppendorf Klinik für Psychiatrie und Psychotherapie

    Hamburg, 20246

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie der Technischen Universität München

    München, 81675

  • Universitäts - und Rehabilitationskliniken Ulm, Neurologie

    Ulm, 89081

Other trials in Germany

Italy4 sites

  • Unità di Neuroimmagine e Epidemiologia Alzheimer

    Brescia, 25125

  • Fondazione Universita' Gabriele D'Annunzio di Chieti

    Chieti Scalo, 66100

  • Fondazione IRCCS Istituto Neurologico "Carlo Besta"

    Milan, 20133

  • Neurology I, Department of Neuroscience, University of Torino

    Torino, 10126

Other trials in Italy

Australia3 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Neuroscience Research Australia

    Randwick, New South Wales, 2031

  • Neurodegenerative Disorders Research Pty Ltd

    West Perth, Western Australia, 6005

Other trials in Australia

Netherlands3 sites

  • Jeroen Bosch Ziekenhuis, afdeling geriatrie

    's-Hertogenbosch, 5223

  • Alzheimer Research Center Amsterdam

    Amsterdam, 1081

  • Erasmus University Medical Center

    Rotterdam, 3015

Other trials in Netherlands

Spain3 sites

  • Fundació ACE. Institut Català de Neurociències Aplicades

    Barcelona, 08028

  • Ceuta University Hospital; Neurology

    Ceuta, 51003

  • Hospital Viamed Montecanal, Neurology Department

    Zaragoza, 50012

Other trials in Spain

Croatia2 sites

  • University Hospital Centre Zagreb

    Zagreb, 10000

  • University Psychiatric Hospital Vrapče

    Zagreb, 10090

Other trials in Croatia

Poland2 sites

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska

    Poznan, 61-853

  • Euromedis Sp. z o.o.

    Szczecin, 70-111

Other trials in Poland

Romania1 site

  • Psychomedical Consult

    Bucharest, 024072

Other trials in Romania

Singapore1 site

  • National Neuroscience Institute Department of Neurology

    Singapore, 308433

Other trials in Singapore

About this study

Official title: 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).

Being tested
TRx0237, Placebo
Keywords
Behavioral Variant Frontotemporal Dementia, bvFTD, Frontotemporal Dementia
Medical subject headings
Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRx0237Drug

    TRx0237 100 mg tablet will be administered twice daily.

  • PlaceboDrug

    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.

Study groups in NCT01626378
Study groupRoleWhat they receive
TRx0237 200 mg/day groupExperimentalNot described
Receives: Drug: TRx0237
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)

    Measured: 52 weeks

  2. Change from Baseline on Functional Activities Questionnaire (FAQ)

    Measured: 52 weeks

  3. Change from Baseline on whole brain volume (assessed by brain MRI)

    Measured: 52 weeks

Secondary outcomes (4)

  1. Change from Baseline on Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III)

    Measured: 52 weeks

  2. Change from Baseline on Frontotemporal Dementia Rating Scale (FRS)

    Measured: 52 weeks

  3. Change from Baseline on Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (modified ADCS-CGIC)

    Measured: 52 weeks

  4. Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes

    Safety parameters included adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, assessment of serotonin syndrome, brain magnetic resonance imaging (MRI) and potential for suicidal behavior and thoughts

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626378
Sponsor's protocol ID
TRx-237-007
Status last verified
Mar 2018
First submitted
20 Jun 2012
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24819148

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRx0237 in people with Behavioral Variant Frontotemporal Dementia (bvFTD), run by TauRx Therapeutics Ltd at 67 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, United Kingdom, Canada, Germany, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R) (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01626378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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