Efficacy and Safety of SOM3355 in Huntington's Disease Chorea
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03575676 |
Recruitment Status :
Completed
First Posted : July 2, 2018
Last Update Posted : September 16, 2019
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Condition or disease | Intervention/treatment | Phase |
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Huntington's Chorea | Drug: SOM3355 100mg BID Drug: SOM3355 200mg BID Drug: Placebo BID | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements. |
Actual Study Start Date : | August 8, 2018 |
Actual Primary Completion Date : | August 22, 2019 |
Actual Study Completion Date : | August 22, 2019 |

Arm | Intervention/treatment |
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Experimental: Group A
Administration of SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks, SOM3355 100mg BID for 6 weeks and placebo BID for 6 weeks.
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Drug: SOM3355 100mg BID
Oral Drug: SOM3355 200mg BID Oral Drug: Placebo BID Oral |
Experimental: Group B
Administration of placebo BID for 6 weeks, SOM3355 100mg BID for 6 weeks, SOM3355 200mg BID for 6 weeks and SOM3355 100mg BID for 6 weeks.
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Drug: SOM3355 100mg BID
Oral Drug: SOM3355 200mg BID Oral Drug: Placebo BID Oral |
- UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score [ Time Frame: 6 months ]UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
- Clinical Global Impression of Change (CGIC) scale [ Time Frame: 6 months ]PGIC reflects clinician's belief about the efficacy of treatment.
- Patient Global Impression of Change (PGIC) scale [ Time Frame: 6 months ]PGIC reflects a patient's belief about the efficacy of treatment.
- UHDRS Total Functional Capacity (TFC) [ Time Frame: 6 months ]A standardized rating scale used to assess capacity to work, handle finances, perform domestic chores and self-care tasks.
- UHDRS Functional Assessment [ Time Frame: 6 months ]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.
- UHDRS Gait score [ Time Frame: 6 months ]UHDRS subscore used to assess patient's gait.
- UHDRS Total Motor Score (TMS) [ Time Frame: 6 months ]Categoric clinical rating scale assessing multiple domains of motor disability in HD.
- Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months ]International validated questionnaire used for suicide assessment.
- Safety (number of participants with adverse events) [ Time Frame: 6 months ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is at least 18 years of age at time of consent.
- Diagnosis of HD definite by a movement disorders expert and confirmed by a number of HTT gene CAG repeats equal or greater than 36.
- Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control.
- Ability to walk independently or with minimal assistance.
- UHDRS TMC score equal or greater than 8.
- UHDRS TFC equal or greater than 4.
- Subject has provided written informed consent or through his/her legally authorized representative.
Exclusion Criteria:
- Onset of HD symptoms prior to age 18 (Juvenile forms of HD).
- Non-ambulatory patients.
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
- Pregnant or breastfeeding female patients, including those planning to conceive during the period of the trial.
- Patients with psychiatric symptoms, or other impairments, that would interfere with their full compliance with the Investigator instructions and testing, unless there is an identified caregiver to support the patient.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical laboratory test results at screening and baseline.
- Known allergy/sensitivity/intolerance to the study drugs or their excipients.
- Any significant laboratory results which, in the Investigator's opinion, would not be compatible with study participation or represent a risk for the subject while in the study.
- Prescribed anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine within 15 days prior starting the investigational treatment.
- Excluded concomitant medications: any anti-hypertensive medication, tetrabenazine, deutetrabenazine or valbenazine, all typical neuroleptics and all MAO inhibitors
- Subject has a history of alcohol or substance abuse in the previous 12 months.
- Patients with diabetic ketoacidosis or metabolic acidosis.
- Patients with cardiogenic shock, congestive heart failure, pulmonary hypertension due to right-sided heart failure, severe sinus bradycardia, atrioventricular block (grades II and III) or sinoatrial block.
- Subject has participated in an investigational drug or device trial within 30 days prior starting the investigational treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575676
Spain | |
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 |
Responsible Party: | SOM Biotech SL |
ClinicalTrials.gov Identifier: | NCT03575676 |
Other Study ID Numbers: |
SOMCT02 2018-000203-16 ( EudraCT Number ) |
First Posted: | July 2, 2018 Key Record Dates |
Last Update Posted: | September 16, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Huntington Chorea SOM3355 |
Huntington Disease Chorea Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Dyskinesias |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders Neurologic Manifestations |