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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02245568




Registration number
NCT02245568
Ethics application status
Date submitted
27/08/2014
Date registered
19/09/2014
Date last updated
24/05/2023

Titles & IDs
Public title
Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Scientific title
An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)
Secondary ID [1] 0 0
TRx-237-020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Behavioral Variant Frontotemporal Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - LMTM

Experimental: LMTM -


Treatment: Drugs: LMTM
The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious or Non-serious Adverse Events
Timepoint [1] 0 0
Up to 34 months

Eligibility
Key inclusion criteria
- Subjects with all cause dementia and probable Alzheimer's disease at enrollment and
who completed participation in one of the following three TauRx studies (inclusive of
the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.

- Subjects with a diagnosis of probable bvFTD at enrollment and who completed
participation in TauRx study TRx-237-007 through Visit 9 (Week 52).

- Females, if of child-bearing potential, must practice true abstinence or continue 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 and ethics approval is/are able to
read, understand, and provide written informed consent

- Has an 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 =1
hour/day =3 days/week; agrees to accompany the subject to each study visit; and is
able to verify daily compliance with study drug

- Able to comply with the study procedures
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of swallowing difficulties

- Pregnant or breastfeeding

- Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging
abnormality (in originating study) or emergent intercurrent illness that, in the
judgment of the principal investigator, could result in the risk of participation
outweighing the potential benefit

- Current participation in, or intent to enroll in, another clinical trial of a drug,
biologic, device, or medical food

- In Germany, subjects mandated to reside in a continuous care or assisted living
facility or those whose willingness to participate in the clinical trial may be unduly
influenced

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
913
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Frontotemporal Research Group - Camperdown
Recruitment hospital [2] 0 0
Division of Rehabilitation and Aged Care - Hornsby
Recruitment hospital [3] 0 0
Southern Neurology Pty Limited - Kogarah
Recruitment hospital [4] 0 0
Discipline of Psychiatry, University of Queensland - Herston
Recruitment hospital [5] 0 0
Royal Adelaide Hospital Memory Trials Centre - Adelaide
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [8] 0 0
McCusker Alzheimer's Research Foundation Inc - Nedlands
Recruitment hospital [9] 0 0
Neurodegenerative Disorders Research Pty Ltd - Subiaco
Recruitment postcode(s) [1] 0 0
2000 - Camperdown
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Arizona
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California
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Illinois
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Iowa
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Massachusetts
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Oklahoma
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Ghent
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Hasselt
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Wilrijk
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Taipei
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Taoyuan
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Aberdeen
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Bath
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Belfast
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Birmingham
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Blackpool
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Cannock
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Crowborough
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Epping
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Guildford
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Leeds
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London
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Manchester
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Oxford
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Shrewsbury
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Southampton
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Swindon

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide subjects who have completed participation in a Phase
2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety
of LMTM.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02245568
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02245568