Trial · NCT05475483
Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
NCT05475483, Phase 2, Completed, SOM Innovation Biotech SA; results first posted 2025-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety on SOM3355 in Huntington's Disease Chorea. Trials, record NCT05475483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05475483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety on SOM3355 in Huntington's Disease Chorea
- NCT number
- NCT05475483
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- SOM Innovation Biotech SA
- Conditions
- Huntington Chorea
- Interventions
- Placebo capsules, SOM3355 200 mg capsules, SOM3355 300 mg capsules
- First posted
- 2022-07-27
- Last updated
- 2025-08-28
- Other registries' IDs
- eudract:2021-003453-28
- Results first posted
- 2025-08-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | From baseline to end of maintenance dose (10 weeks of treatment). | Pre-defined analysis of the primary efficacy endpoint (change in TMC score from baseline to the end of maintenance dose) performed with the 122 subjects of the mITT not taking neuroleptics during the trial. The TMC is part of the motor assessment of the Unified Huntington's Disease Rating Scale (UHDRS) and measures chorea in 7 different body parts, including the face, oral-buccal-lingual region, trunk, and each limb independently. The TMC score is the sum of the individual scores, ranging from 0 to 28. A decrease in TMC scores indicates improvement in chorea symptoms. |
| Secondary | Change in the Clinical Global Impression (CGI) (mITT - N=139) | From baseline to end of maintenance dose (10 weeks of treatment). | The key secondary endpoint was the Clinical Global Impression of Change (CGI-C) at Visit 5 (week 10). The key secondary efficacy analysis was conducted on the mITT Population, including 139 subjects. Subjects with a score of 1 (Very much improved), 2 (Much improved), or 3 (Minimally improved) were defined as "Improved", and patients with a score of 4 (No change), 5 (Worse), 6 (Much worse), and 7 (Very much worse) were defined as "Not Improved". |
| Secondary | Change in the Patient Global Impression (PGI) (mITT - N=139) | From baseline to end of maintenance dose (10 weeks of treatment). | Another relevant secondary endpoint was the Patient Global Impression of Change (PGI-C) at Visit 5 (week 10). The efficacy analysis was conducted on the mITT Population, including 139 subjects. Subjects with a score of 1 (Very much improved), 2 (Much improved), or 3 (Minimally improved) were defined as "Improved", and patients with a score of 4 (No change), 5 (Worse), 6 (Much worse), and 7 (Very much worse) were defined as "Not Improved". |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | From baseline to end of maintenance dose (10 weeks of treatment). | 122 subjects of the mITT not taking neuroleptics during the trial. The modified Intention-to-Treat (mITT) population comprises all patients randomized to a treatment arm who received at least one dose of study drug and had at least one post-baseline assessment of the TMC score (N=139). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Clinical Global Impression (CGI) (mITT - N=139) | From baseline to end of maintenance dose (10 weeks of treatment). | Modified Intention-to-Treat (mITT) population included all patients randomized to a treatment arm, who received at least one dose of study drug and had at least one post-baseline assessment of the TMC score. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Patient Global Impression (PGI) (mITT - N=139) | From baseline to end of maintenance dose (10 weeks of treatment). | Modified Intention-to-Treat (mITT) population included all patients randomized to a treatment arm, who received at least one dose of study drug and had at least one post-baseline assessment of the TMC score. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Change in Total Maximal Chorea (TMC) Score for Subjects Not Taking Neuroleptics and With Mean Baseline TMC Score >12 (mITT - N=57) | From baseline to end of maintenance dose (10 weeks of treatment). | 57 subjects of the mITT not taking neuroleptics during the trial and with a mean baseline TMC score \>12. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | Placebo | -2.19 | 95% Confidence Interval -3.07 to -1.32 | units on a scale | |
| Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | SOM3355 400 mg/Day | -2.42 | 95% Confidence Interval -3.32 to -1.51 | units on a scale | |
| Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | SOM3355 600 mg/Day | -3.46 | 95% Confidence Interval -4.35 to -2.58 | units on a scale | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | Placebo | Improved | 15 | Participants | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | SOM3355 400 mg/Day | Improved | 26 | Participants | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | SOM3355 600 mg/Day | Improved | 23 | Participants | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | Placebo | Not Improved | 26 | Participants | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | SOM3355 400 mg/Day | Not Improved | 11 | Participants | |
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | SOM3355 600 mg/Day | Not Improved | 18 | Participants | |
| Change in the Patient Global Impression (PGI) (mITT - N=139) | Placebo | Improved | 20 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | STARTED | SOM3355 400 mg/Day | 41 | |
| Overall Study | STARTED | SOM3355 600 mg/Day | 50 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | COMPLETED | SOM3355 400 mg/Day | 36 | |
| Overall Study | COMPLETED | SOM3355 600 mg/Day | 41 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | SOM3355 400 mg/Day | 5 | |
| Overall Study | NOT COMPLETED | SOM3355 600 mg/Day | 9 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fall | Injury, poisoning and procedural complications | Placebo | 2 | 48 | 5 |
| other | Fall | Injury, poisoning and procedural complications | SOM3355 400 mg/Day | 3 | 41 | 6 |
| other | Fall | Injury, poisoning and procedural complications | SOM3355 600 mg/Day | 4 | 50 | 7 |
| other | Bradycardia | Vascular disorders | Placebo | 0 | 48 | 0 |
| other | Bradycardia | Vascular disorders | SOM3355 400 mg/Day | 2 | 41 | 2 |
| other | Bradycardia | Vascular disorders | SOM3355 600 mg/Day | 6 | 50 | 7 |
| other | Somnolence | Nervous system disorders | Placebo | 3 | 48 | 3 |
| other | Somnolence | Nervous system disorders | SOM3355 400 mg/Day | 1 | 41 | 1 |
| other | Somnolence | Nervous system disorders | SOM3355 600 mg/Day | 3 | 50 | 3 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 48 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 48 |
| Total, all-cause mortality | SOM3355 400 mg/Day | 0 | 41 |
| Total, all-cause mortality | SOM3355 600 mg/Day | 0 | 50 |
| Total, other adverse events | Placebo | 10 | 48 |
| Total, other adverse events | SOM3355 400 mg/Day | 15 | 41 |
| Total, other adverse events | SOM3355 600 mg/Day | 22 | 50 |
| Total, serious adverse events | Placebo | 1 | 48 |
| Total, serious adverse events | SOM3355 400 mg/Day | 1 | 41 |
| Total, serious adverse events | SOM3355 600 mg/Day | 1 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42857615 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05475483
GET https://conductscience.org/api/trials/v1/NCT05475483/events?page=2