This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Change from baseline to day 21 in QMG total score for NMD670 vs placebo
Scale goes from 0-39 and higher score indicates worse symptomatology
Time frame: Baseline to day 21
Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo
Scale goes from 0-24 and higher score indicates worse symptomatology
Time frame: Baseline to day 21
Change from baseline to day 21 in MGC total score for NMD670 vs placebo
Scale goes from 0-50 and higher score indicate worse symptomatology
Time frame: Baseline to day 21
Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo
Scale goes from 0-30 and higher score indicate worse quality of life
Time frame: Baseline to day 21
Change from baseline to day 21 in Neuro-QoL Fatigue Short Form
Scale goes from 8-40 and higher score indicate worse symptomalogy
Time frame: Baseline to day 21
Incidence of treatment emergent adverse event
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of serious treatment emergent adverse events
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on physical examinations
Summarised per treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Profound Research LLC
Carlsbad, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California Irvine Medical Center
Irvine, California, United States
RECRUITINGUniversity of Colorado Neuromuscular Division
Aurora, Colorado, United States
RECRUITINGSFM Clinical Research, LLC
Boca Raton, Florida, United States
RECRUITINGNeuromuscular Research Division | University of South Florida
Tampa, Florida, United States
RECRUITINGAugusta University, Neuroscience Center
Augusta, Georgia, United States
RECRUITINGNextGen Precision Health
Columbia, Missouri, United States
RECRUITINGThe University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Oregon
Portland, Oregon, United States
RECRUITING...and 29 more locations
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on safety laboratory parameters
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of clinically significant vital signs abnormalities
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of clinically significant ECG abnormalities
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of Suicidal Ideation or Suicidal Behavior
Summarised per treatment
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on opthalmological examinations
Summarised per treatment
Time frame: From screening (day -28 to day -1) until follow up (day 28)