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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
913
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).
Number of Participants With Serious or Non-serious Adverse Events
Study-emergent adverse events (including the onset of new adverse events or worsening of pre-existing adverse events) were recorded from the time of first dose in this study to the end of study participation. All laboratory test, vital sign, or electrocardiogram parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.
Time frame: Up to 34 months
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Xenoscience, Inc / 21st Century Neurology
Phoenix, Arizona, United States
Southern California Research, LLC
Fountain Valley, California, United States
Feldman, Robert MD
Laguna Hills, California, United States
Collaborative Neuroscience Network
Long Beach, California, United States
The Shankle Clinic
Newport Beach, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Pacific Research Network
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Memory and Aging Centre
San Francisco, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
...and 125 more locations