A Trial of LMTM in Patients with bvFTD (TRx-237-007)
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD)
IRAS ID
109199
Contact name
Christopher Kipps
Sponsor organisation
Worldwide Clinical Trials Limited
Eudract number
2011-005529-34
Clinicaltrials.gov Identifier
Research summary
BvFTD is a rare, progressive neurodegenerative disease characterized by progressive deterioration of behaviour and language, associated with atrophy of the frontal and temporal lobes. It typically occurs sometime in the 50s, though it can occur as early as age 20 or as late as age 80. There are currently no licensed treatments for any form of FTD. TRx-237-007 is a Phase III study aiming to assess the efficacy, safety and tolerability in LMTM in subjects with bvFTD. Subjects enrolled in this study must have an identified caregiver able and willing to assist with the subject??s study participation. Eligible patients will receive at the baseline visit to one of the following two treatment groups: the TRx0237 or the placebo group. Placebo tablets will include 4 mg LMTM as a urinary and faecal colorant to maintain blinding. The target recruitment number is approximately 180 subjects (90 per arm). This study is designed as Multinational, randomized, placebo-controlled, double-blind, parallel-group, 52-week, outpatient study with seven post-baseline on-treatment visits planned and an off-treatment follow-up visit for subjects who either discontinue early or complete treatment but chose not to enter a separate open-label extension study. Unscheduled visits and housing may occur as needed for assessment. A number of rating scales will be administered to assess the benefit of patients through defined primary and secondary outcomes measures. Safety will be monitored during the study through a number of safety measures, blood samples, ECGs, MRI imaging and rating scales. The total duration of participation for an individual subject will be up to 62 weeks, including a Screening period of up to 42 days, a double-blind treatment study of 52 weeks, and a post-treatment assessment 28 days after completion of randomized treatment. It is anticipated that the study will have an overall duration of approximately 28 months, assuming an enrolment period of approximately 1 year. In addition, a separate open-label extension study is planned.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
12/SC/0538
Date of REC Opinion
17 Jan 2013
REC opinion
Further Information Favourable Opinion