Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01626378




Registration number
NCT01626378
Ethics application status
Date submitted
20/06/2012
Date registered
22/06/2012
Date last updated
14/03/2018

Titles & IDs
Public title
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
Scientific 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)
Secondary ID [1] 0 0
TRx-237-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioral Variant Frontotemporal Dementia (bvFTD) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TRx0237
Treatment: Drugs - Placebo

Experimental: TRx0237 200 mg/day group -

Placebo comparator: Placebo -


Treatment: Drugs: TRx0237
TRx0237 100 mg tablet will be administered twice daily.

Treatment: Drugs: Placebo
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline on Addenbrooke's Cognitive Examination - Revised (ACE-R)
Timepoint [1] 0 0
52 weeks
Primary outcome [2] 0 0
Change from Baseline on Functional Activities Questionnaire (FAQ)
Timepoint [2] 0 0
52 weeks
Primary outcome [3] 0 0
Change from Baseline on whole brain volume (assessed by brain MRI)
Timepoint [3] 0 0
52 weeks
Secondary outcome [1] 0 0
Change from Baseline on Unified Parkinson's Disease Rating Scale (UPDRS Parts II and III)
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Change from Baseline on Frontotemporal Dementia Rating Scale (FRS)
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Change from Baseline on Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (modified ADCS-CGIC)
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
Timepoint [4] 0 0
52 weeks

Eligibility
Key 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
Minimum age
No limit
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Neurodegenerative Disorders Research Pty Ltd - West Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
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Oklahoma
Country [14] 0 0
United States of America
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Pennsylvania
Country [15] 0 0
United States of America
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Utah
Country [16] 0 0
United States of America
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Vermont
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United States of America
State/province [17] 0 0
Virginia
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Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Croatia
State/province [23] 0 0
Zagreb
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
München
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Italy
State/province [28] 0 0
Brescia
Country [29] 0 0
Italy
State/province [29] 0 0
Chieti Scalo
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Torino
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Netherlands
State/province [32] 0 0
Amsterdam
Country [33] 0 0
Netherlands
State/province [33] 0 0
Den Bosch
Country [34] 0 0
Netherlands
State/province [34] 0 0
Rotterdam
Country [35] 0 0
Poland
State/province [35] 0 0
Poznan
Country [36] 0 0
Poland
State/province [36] 0 0
Szczecin
Country [37] 0 0
Romania
State/province [37] 0 0
Bucharest
Country [38] 0 0
Singapore
State/province [38] 0 0
Singapore
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Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
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Ceuta
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Spain
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Zaragoza
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United Kingdom
State/province [42] 0 0
Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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Cheltenham
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United Kingdom
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Derby
Country [46] 0 0
United Kingdom
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Epping
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Oxford
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Shrewsbury
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TauRx Therapeutics Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01626378