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

NCT01626378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-03-14

No results posted yet for this study

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).

Conditions

  • Behavioral Variant Frontotemporal Dementia (bvFTD)

Interventions

DRUG

TRx0237

TRx0237 100 mg tablet will be administered twice daily.

DRUG

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.

Sponsors & Collaborators

  • TauRx Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Australia
  • Canada
  • Croatia
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Singapore
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01626378 on ClinicalTrials.gov