Phase 2
Completed N=139
Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
Huntington Chorea
Source: ClinicalTrials.gov NCT05475483 ↗
Enrolled (actual)
139
Serious AEs
2.2%
Results posted
Aug 2025
Primary outcomePrimary: Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) — -2.19; -2.42; -3.46 units on a scale — p== 0.045
Summary
Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) |
-2.19; -2.42; -3.46 | = 0.045 sig |
| SECONDARY Change in the Clinical Global Impression (CGI) (mITT - N=139) |
15; 26; 23; 26; 11; 18 | = 0.078 |
| SECONDARY Change in the Patient Global Impression (PGI) (mITT - N=139) |
20; 25; 26; 21; 12; 14 | 0.143 |
Eligibility Criteria
Inclusion Criteria: Males or females ≥21 years old, a diagnosis of Huntington's Disease determined by a movement disorders expert and confirmed by a number of HTT gene CAG repeats ≥36, a UHDRS® Total maximal chorea (TMC) score ≥10, and a UHDRS® Total Functional Capacity (TFC) ≥7.
Exclusion Criteria: Onset of HD symptoms prior to age of 21 years (juvenile forms of HD), HD patients presenting rigid akinesia, and use of other VMAT2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine, or other antichoreic treatment such as any neuroleptic, or amantadine, memantine, riluzole.
Data sourced from ClinicalTrials.gov (NCT05475483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.