Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score
UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
Time frame: 6 months
Clinical Global Impression of Change (CGIC) scale
PGIC reflects clinician's belief about the efficacy of treatment.
Time frame: 6 months
Patient Global Impression of Change (PGIC) scale
PGIC reflects a patient's belief about the efficacy of treatment.
Time frame: 6 months
UHDRS Total Functional Capacity (TFC)
A standardized rating scale used to assess capacity to work, handle finances, perform domestic chores and self-care tasks.
Time frame: 6 months
UHDRS Functional Assessment
Functional Assessment should be judged according to the investigator's opinion of capacity to perform the activity rather than the actual performance of this activity.
Time frame: 6 months
UHDRS Gait score
UHDRS subscore used to assess patient's gait.
Time frame: 6 months
UHDRS Total Motor Score (TMS)
Categoric clinical rating scale assessing multiple domains of motor disability in HD.
Time frame: 6 months
Columbia Suicide Severity Rating Scale (C-SSRS)
International validated questionnaire used for suicide assessment.
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Time frame: 6 months
Safety (number of participants with adverse events)
The maximum grade for each type of AE will be recorded for each subject, and frequency tables will be presented and reviewed to determine patterns. The relationship of the AE to the study treatment will be taken into consideration. Hypotension and cardiovascular events will be specifically analyzed.
Time frame: 6 months