Efficacy and Safety of SOM3355 in Huntington's Disease Chorea
Phase IIa, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of SOM3355 in Huntington's Disease (HD) Patients With Chorea Movements.
2 other identifiers
interventional
32
1 country
4
Brief Summary
Phase IIa study to evaluate the efficacy and safety of SOM3355 in chorea movements associated with Huntington's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2018
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedStudy Start
First participant enrolled
August 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedSeptember 16, 2019
September 1, 2019
1 year
June 11, 2018
September 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UHDRS (Unified Huntington's Disease Rating Scale) Total Maximal Chorea (TMC) score
UHDRS subscore used to measure the effectiveness of SOM3355 on HD chorea.
6 months
Secondary Outcomes (8)
Clinical Global Impression of Change (CGIC) scale
6 months
Patient Global Impression of Change (PGIC) scale
6 months
UHDRS Total Functional Capacity (TFC)
6 months
UHDRS Functional Assessment
6 months
UHDRS Gait score
6 months
- +3 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALAdministration 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.
Group B
EXPERIMENTALAdministration 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
Related Publications (1)
Gamez J, Calopa M, Munoz E, Ferre A, Huertas O, McAllister K, Reig N, Scart-Gres C, Insa R, Kulisevsky J. A proof-of-concept study with SOM3355 (bevantolol hydrochloride) for reducing chorea in Huntington's disease. Br J Clin Pharmacol. 2023 May;89(5):1656-1664. doi: 10.1111/bcp.15635. Epub 2022 Dec 28.
PMID: 36494329DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
July 2, 2018
Study Start
August 8, 2018
Primary Completion
August 22, 2019
Study Completion
August 22, 2019
Last Updated
September 16, 2019
Record last verified: 2019-09