The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is administered orally over 12 weeks to male and female patients with Huntington's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
50 mg oral once daily tablet
200 mg oral once daily tablet
oral once daily tablet
Dept. of Neurology, University of Münster
Münster, Germany
Safety and tolerability
Adverse event (AE) reporting, 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and laboratory safety tests. Suicide risk (Columbia Suicide Severity Rating Scale,C-SSRS).
Time frame: 12 weeks
Short-term clinical effects
Global Clinical Impression (GCI, patient and clinician-based), UHDRS, Total Motor Scale (UHDRS-TMS), Functional Assessment, Independence Scale Assessment, Problem Behaviours Assessment, Cognitive Battery (Symbol Digit Modalities Test, Stroop Word Test, Verbal fluency, Mini-Mental State Examination \[MMSE\]).
Time frame: 12 weeks
Modulation of candidate pharmacodynamic markers
Acetylation status of mutant huntingtin, levels of soluble huntingtin.
Time frame: 12 weeks
Pharmacokinetic profile
Time frame: 12 weeks
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