NCT02245568

Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 913 (actual)
• Sponsor: TauRx Therapeutics Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease
• Behavioral Variant Frontotemporal Dementia

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-09-19
• Last updated: 2023-05-24
• Results posted: 2020-06-02

Locations

135 sites across 17 countries: United States, Australia, Belgium, Canada, Croatia, Finland, France, Germany, Malaysia, Netherlands, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study