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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003453-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. |
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| SOM3355 400 mg/day | Experimental | SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. |
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| SOM3355 600 mg/day | Experimental | SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo capsules | Drug | Treatment was blind for the whole duration of the study. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | 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. | From baseline to end of maintenance dose (10 weeks of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Clinical Global Impression (CGI) (mITT - N=139) | 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". |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Angers | Angers | France | ||||
| CHU Hôpital Henri Mondor (APHP) |
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| Label | URL |
|---|---|
| SOM Biotech website | View source |
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A total of 139 patients with Huntington's disease were randomized and treated between August 2022 and April 2024 at 23 sites in 7 European countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. Placebo capsules: Treatment was blind for the whole duration of the study. |
| FG001 | SOM3355 400 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2022 | Jun 26, 2025 |
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| SOM3355 200 mg capsules |
| Drug |
Treatment was blind for the whole duration of the study. |
|
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| SOM3355 300 mg capsules | Drug | Treatment was blind for the whole duration of the study. |
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| From baseline to end of maintenance dose (10 weeks of treatment). |
| Change in the Patient Global Impression (PGI) (mITT - N=139) | 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". | From baseline to end of maintenance dose (10 weeks of treatment). |
| Créteil |
| France |
| Hôpital Roger Salengro - CHU Lille | Lille | France |
| Hopital de Hautepierre | Strasbourg | France |
| Hôpital Purpan - CHU Toulouse | Toulouse | France |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| George Huntington Institut | Münster | Germany |
| Kbo-Isar-Amper-Klinikum Taufkirchen | Taufkirchen | Germany |
| Hospital of University of Ulm | Ulm | Germany |
| IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | Italy |
| IRCCS Casa Sollievo della Sofferenza | Roma | Italy |
| Sant'Andrea University Hospital | Roma | Italy |
| Krakowska Akademia Neurologii Sp. z o.o. | Krakow | Poland |
| Indywidualna Praktyka Lekarska Daniel Zielonka | Poznan | Poland |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario de Cruces | Bilbao | Spain |
| Hospital Universitario de Burgos | Burgos | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Universitaetsspital Bern - Inselspital | Bern | Switzerland |
| Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital | Cambridge | United Kingdom |
| NIHR Wellcome Trust Manchester Clinical Research Facility | Manchester | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose.
SOM3355 200 mg capsules: Treatment was blind for the whole duration of the study.
| FG002 | SOM3355 600 mg/Day | SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. Placebo capsules: Treatment was blind for the whole duration of the study. |
| BG001 | SOM3355 400 mg/Day | SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. SOM3355 200 mg capsules: Treatment was blind for the whole duration of the study. |
| BG002 | SOM3355 600 mg/Day | SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Use of Neuroleptics | Antipsychotic drugs (excluding haloperidol, pimozide, and tiapride) prescribed to treat behaviour disorders at a stable dose for at least 3 months before entering the study. | Count of Participants | Participants |
| |||||||||||||||
| Total Maximal Chorea (TMC) score | 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. Lower values in the TMC score represent less chorea symptoms and a better outcome. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Maximal Chorea (TMC) Score of the UHDRS® for Subjects Not Taking Neuroleptics During the Trial (mITT - N=122) | 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. | 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). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From baseline to end of maintenance dose (10 weeks of treatment). |
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| Secondary | Change in the Clinical Global Impression (CGI) (mITT - N=139) | 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". | 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. | Posted | Count of Participants | Participants | From baseline to end of maintenance dose (10 weeks of treatment). |
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| Secondary | Change in the Patient Global Impression (PGI) (mITT - N=139) | 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". | 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. | Posted | Count of Participants | Participants | From baseline to end of maintenance dose (10 weeks of treatment). |
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| Post-Hoc | Change in Total Maximal Chorea (TMC) Score for Subjects Not Taking Neuroleptics and With Mean Baseline TMC Score >12 (mITT - N=57) | Post-hoc analysis of the primary efficacy endpoint (change in TMC score from baseline to the end of maintenance dose) was performed in 57 subjects of the mITT not taking neuroleptics during the trial and with a mean baseline TMC score >12. 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. | 57 subjects of the mITT not taking neuroleptics during the trial and with a mean baseline TMC score >12. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From baseline to end of maintenance dose (10 weeks of treatment). |
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From Baseline (visit 1) until End of Study visit (up to 13 weeks of treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. Placebo capsules: Treatment was blind for the whole duration of the study. | 0 | 48 | 1 | 48 | 10 | 48 |
| EG001 | SOM3355 400 mg/Day | SOM3355 200 mg capsules were administered twice daily (BID) for at least 9 weeks at maintenance dose. SOM3355 200 mg capsules: Treatment was blind for the whole duration of the study. | 0 | 41 | 1 | 41 | 15 | 41 |
| EG002 | SOM3355 600 mg/Day | SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. | 0 | 50 | 1 | 50 | 22 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope (overdose) | Nervous system disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Bradycardia | Vascular disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | SOM Innovation Biotech SA | +41 79 552 15 78 | medori@sombiotech.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2024 | Jun 26, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C021148 | bevantolol |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| African (North) |
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| Latino |
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| Other (in France) |
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| Italy |
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| United Kingdom |
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| France |
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| Switzerland |
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| Germany |
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| Spain |
|
| No |
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SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. |
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SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. |
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| OG002 | SOM3355 600 mg/Day | SOM3355 300 mg capsules were administered twice daily (BID) for at least 8 weeks at maintenance dose. SOM3355 300 mg capsules: Treatment was blind for the whole duration of the study. |
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