Clinical Trials List
Protocol NumberTRx-237-020
NCT Number(ClinicalTrials.gov Identfier)NCT02245568
2015-02-01 - 2017-12-31
Phase III
Terminated4
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
TRx-237-020: An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis (hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia
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Trial Applicant
WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
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Sponsor
TauRx Therapeutics Ltd (TauRx)
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- TA-FU CHEN Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Alzheimer’s Disease
Objectives
To provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and
to evaluate the long-term safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) given in
flexible doses of up to 300 mg/day.
Test Drug
Leuco-methylthioninium bis (hydromethanesulfonate) (LMTM, TRx0237)
Active Ingredient
Leuco-methylthioninium bis (hydromethanesulfonate)
Dosage Form
Tablet
Dosage
100
Endpoints
Baseline:
Following the signing of informed consent, the following Baseline assessments are to be performed in order to
confirm continued eligibility for study:
x If the Baseline visit does not coincide with the final double-blind study visit, intervening medical history,
adverse events, and concomitant medication use are to be recorded; serum pregnancy testing in women of
childbearing potential is to be performed.
x If the final double-blind study visit occurred more than 42 days prior, safety assessments are to be repeated,
including seated vital signs, clinical laboratory tests, and if indicated, targeted physical and neurological
examinations.
Safety and Tolerability:
At each post-Baseline visit (unless otherwise noted), whether or not subjects are on study medication, all adverse
events (AEs), concomitant medications, vital signs, and clinical laboratory findings will be assessed (unless
otherwise noted) according to the following:
x Adverse events recording.
x Concomitant medication use.
x Seated blood pressure and pulse (after the subject has been at rest in a seated position for approximately
5 minutes, with pulse recorded over 60 seconds).
x Body weight.
x Standard clinical laboratory testing, including hematology and serum chemistry.
x A serum pregnancy test (women of childbearing potential).
x Targeted physical and neurological assessments (as needed in response to an AE or to changes in the subject’s
physical condition or medical history).
Resource Utilization and Quality of Life:
The following scales will be evaluated at Baseline (if not available from within the prior 42 days in the previous
study of participation) and approximately every 6 months:
x RUD-Lite.
x EQ-5D-5L.
Following the signing of informed consent, the following Baseline assessments are to be performed in order to
confirm continued eligibility for study:
x If the Baseline visit does not coincide with the final double-blind study visit, intervening medical history,
adverse events, and concomitant medication use are to be recorded; serum pregnancy testing in women of
childbearing potential is to be performed.
x If the final double-blind study visit occurred more than 42 days prior, safety assessments are to be repeated,
including seated vital signs, clinical laboratory tests, and if indicated, targeted physical and neurological
examinations.
Safety and Tolerability:
At each post-Baseline visit (unless otherwise noted), whether or not subjects are on study medication, all adverse
events (AEs), concomitant medications, vital signs, and clinical laboratory findings will be assessed (unless
otherwise noted) according to the following:
x Adverse events recording.
x Concomitant medication use.
x Seated blood pressure and pulse (after the subject has been at rest in a seated position for approximately
5 minutes, with pulse recorded over 60 seconds).
x Body weight.
x Standard clinical laboratory testing, including hematology and serum chemistry.
x A serum pregnancy test (women of childbearing potential).
x Targeted physical and neurological assessments (as needed in response to an AE or to changes in the subject’s
physical condition or medical history).
Resource Utilization and Quality of Life:
The following scales will be evaluated at Baseline (if not available from within the prior 42 days in the previous
study of participation) and approximately every 6 months:
x RUD-Lite.
x EQ-5D-5L.
Inclution Criteria
Inclusion Criteria
1. Subjects with a diagnosis according to NIA/AA criteria of all cause dementia and probable Alzheimer’s
disease (AD) 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-237-008, TRx-237-015, and TRx-237-005.
OR
Subjects with a diagnosis of probable bvFTD according to the International Consensus Criteria for behavioral
variant frontotemporal dementia (bvFTD) at enrollment and who completed participation in TauRx study TRx237-007 through Visit 9 (Week 52).
Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior
participation prior to completion.
2. Females of child-bearing potential must continue to use adequate contraception (or, if in Italy, agree to avoid
pregnancy) defined as follows:
x barrier method (such as condom, diaphragm or cervical/vault cap) with spermicidal foam, gel, film, cream,
or suppository; intrauterine device (IUD) or system; oral or long-acting injected or implanted hormonal
contraceptives for at least 3 months prior to Baseline; or vasectomized partner (with the appropriate postvasectomy documentation of the absence of spermatozoa in the ejaculate); or true abstinence (when this is
in line with the preferred and usual lifestyle of the subject)
x subjects must agree to continue to maintain adequate contraception throughout participation in the study
3. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent
with national law and IRB/EC approval, is/are able to read, understand, and provide written informed consent
in the designated language of the study site
x In Germany, subjects must be able to provide their own written informed consent
4. Has an identified adult caregiver who meets the following criteria:
x Either lives with the subject or sees the subject on average for 1 hour/day 3 days/week, and in the
investigator’s opinion, the extent of contact is sufficient to provide meaningful assessment of changes in
subject behavior and function over time and provide information on safety and tolerability
x Is willing to provide written informed consent for his/her own participation
x Is able to read, understand, and speak the designated language at the study site
x Agrees to accompany the subject to each study visit
x Is able to verify daily compliance with study drug
5. Able to comply with the study procedures in the view of the investigator
1. Subjects with a diagnosis according to NIA/AA criteria of all cause dementia and probable Alzheimer’s
disease (AD) 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-237-008, TRx-237-015, and TRx-237-005.
OR
Subjects with a diagnosis of probable bvFTD according to the International Consensus Criteria for behavioral
variant frontotemporal dementia (bvFTD) at enrollment and who completed participation in TauRx study TRx237-007 through Visit 9 (Week 52).
Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior
participation prior to completion.
2. Females of child-bearing potential must continue to use adequate contraception (or, if in Italy, agree to avoid
pregnancy) defined as follows:
x barrier method (such as condom, diaphragm or cervical/vault cap) with spermicidal foam, gel, film, cream,
or suppository; intrauterine device (IUD) or system; oral or long-acting injected or implanted hormonal
contraceptives for at least 3 months prior to Baseline; or vasectomized partner (with the appropriate postvasectomy documentation of the absence of spermatozoa in the ejaculate); or true abstinence (when this is
in line with the preferred and usual lifestyle of the subject)
x subjects must agree to continue to maintain adequate contraception throughout participation in the study
3. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent
with national law and IRB/EC approval, is/are able to read, understand, and provide written informed consent
in the designated language of the study site
x In Germany, subjects must be able to provide their own written informed consent
4. Has an identified adult caregiver who meets the following criteria:
x Either lives with the subject or sees the subject on average for 1 hour/day 3 days/week, and in the
investigator’s opinion, the extent of contact is sufficient to provide meaningful assessment of changes in
subject behavior and function over time and provide information on safety and tolerability
x Is willing to provide written informed consent for his/her own participation
x Is able to read, understand, and speak the designated language at the study site
x Agrees to accompany the subject to each study visit
x Is able to verify daily compliance with study drug
5. Able to comply with the study procedures in the view of the investigator
Exclusion Criteria
Exclusion Criteria
1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken
crushed, chewed or dissolved in fluids prior to ingestion)
2. Pregnant or breastfeeding
3. Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in original
study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk
of participation outweighing the potential benefit
4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food
1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken
crushed, chewed or dissolved in fluids prior to ingestion)
2. Pregnant or breastfeeding
3. Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in original
study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk
of participation outweighing the potential benefit
4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1400 participants
