Trials / Completed
CompletedNCT01626378
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- TauRx Therapeutics Ltd · Industry
- Sex
- All
- Age
- 79 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2012-06-22
- Last updated
- 2018-03-14
Locations
67 sites across 12 countries: United States, Australia, Canada, Croatia, Germany, Italy, Netherlands, Poland, Romania, Singapore, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01626378. Inclusion in this directory is not an endorsement.