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Trial record 4 of 9 for:    TauRx

Open-Label Study of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02245568
First Posted: September 19, 2014
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TauRx Therapeutics Ltd
  Purpose
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial with TRx0237 continued access to therapy and to evaluate the long-term safety of TRx0237.

Condition Intervention Phase
Alzheimer's Disease Behavioral Variant Frontotemporal Dementia Drug: TRx0237 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Study of the Effects of TRx0237 in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

Resource links provided by NLM:


Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • Number of participants with serious and non-serious adverse events [ Time Frame: Up to 37 months ]
  • Change from Baseline in laboratory test values [ Time Frame: Up to 37 months ]
    Standard hematology and serum chemistry parameters to be measured

  • Change from Baseline in vital signs [ Time Frame: Up to 37 months ]
    Vital signs to be measured include blood pressure and pulse, temperature, respiratory rate and weight


Other Outcome Measures:
  • Score of Euro Quality of Life - 5-level version (EQ-5D-5L) [ Time Frame: Up to 37 months ]
  • Score of Resource Utilization in Dementia Questionnaire-Lite (RUD-Lite) [ Time Frame: Up to 37 months ]

Estimated Enrollment: 1000
Study Start Date: August 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRx0237 Drug: TRx0237
All subjects will initially be given 200 mg/day of TRx0237 (one 100-mg tablet in the morning and one 100-mg tablet in the evening). Thereafter, dosing is flexible (100 mg/day to 300 mg/day).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245568


  Show 136 Study Locations
Sponsors and Collaborators
TauRx Therapeutics Ltd
  More Information

Responsible Party: TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02245568     History of Changes
Other Study ID Numbers: TRx-237-020
First Submitted: August 27, 2014
First Posted: September 19, 2014
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by TauRx Therapeutics Ltd:
Dementia
Alzheimer Disease
bvFTD
Frontotemporal Dementia
Neurodegenerative Diseases
Brain Diseases
Cognitive Disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms