The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in subjects with Huntington's disease (HD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Unnamed facility
San Diego, California, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Tampa, Florida, United States
Assess the Safety of OMS643762
Safety as assessed by adverse events
Time frame: 28 days
Assess the Safety of OMS643762
Safety as assessed by vital signs
Time frame: 28 days
Assess the Safety of OMS643762
Safety as assessed by clinical lab-tests
Time frame: 28 days
Assess the Safety of OMS643762
Safety as assessed by ECG
Time frame: 28 days
Assess the Safety of OMS643762
Safety as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 28 days
Motor function
Change from baseline in the UHDRS - Total Motor Score
Time frame: Pre-dose and day 15 and 28 post-dose
Motor function
Change from baseline in the Speeded Tapping Test score
Time frame: Pre-dose and day 15 and 28 post-dose
Cognition
Change from baseline in the Cognitive Assessment Battery composite score
Time frame: Pre-dose and day 28 post-dose
Behavior
Change from baseline in the Problem Behavior Assessment score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Memphis, Tennessee, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Kirkland, Washington, United States
Time frame: Pre-dose and day 28 of dosing
Pharmacokinetics profile
Maximum plasma concentration of OMS643762 following multiple-dose administration
Time frame: Pre-dose, day 15 and 28 of dosing and up to 14 days post-dose