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Trial record 1 of 1 for:    SOMCT03
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Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

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ClinicalTrials.gov Identifier: NCT05475483
Recruitment Status : Recruiting
First Posted : July 27, 2022
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
SOM Innovation Biotech SA

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Huntington Chorea Drug: SOM3355 capsules Drug: Placebo capsules Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SOM3355 300 mg BID
Administration of SOM3355 in up-titration for 3 weeks up to the maintenance dose of 300 mg BID (twice daily) administered for 7 additional weeks, and down-titration for 2 weeks.
 Drug: SOM3355 capsules
Treatment will be blind for the whole duration of the study.
Other Name: Bevantolol hydrochloride
Experimental: SOM3355 200 mg BID
Administration of SOM3355 in up-titration for 2 weeks up to the maintenance dose of 200 mg BID (twice daily) administered for 8 additional weeks, and down-titration for 2 weeks.
 Drug: SOM3355 capsules
Treatment will be blind for the whole duration of the study.
Other Name: Bevantolol hydrochloride
Placebo Comparator: Placebo BID
Administration of matching Placebo BID (twice daily) for 12 weeks.
 Drug: Placebo capsules
Treatment will be blind for the whole duration of the study.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Total Maximal Chorea (TMC) score of the UHDRS® [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
    Total Maximal Chorea score of the Unified Huntington Disease Rating Scale is 0-28 and decrease means improvement.


Secondary Outcome Measures :
  1. Change in the Clinical Global Impression (CGI) [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  2. Change in the Patient Global Impression (PGI) [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  3. TMC-response defined as improvement ≥2 in TMC score [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  4. Percentage of change in TMC score [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  5. Change in the Total Motor Score (TMS) of the UHDRS® [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
    Total Motor Score is 0-124 and decrease means improvement.

  6. Change in the Gait sub-score of the UHDRS® [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  7. Change in the Dystonia sub-score of the UHDRS® [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]
  8. Change in the European Quality of Life scale (EQ-5D-5L) [ Time Frame: Between baseline and end of maintenance dose (after 10 weeks of treatment) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ≥21 years old.
  2. Patients with a diagnosis of Huntington's Disease determined by a movement disorders expert and confirmed by a number of HTT gene CAG repeats ≥36.
  3. UHDRS® Total maximal chorea (TMC) score ≥10.
  4. UHDRS® Total Functional Capacity (TFC) ≥7.
  5. Able to walk independently or with minimal assistance.
  6. Females of child-bearing potential must use a medically accepted effective method of birth control and should not be breast-feeding.
  7. In the opinion of the Investigator, the patient must have adequate support to comply with the entire study requirements.
  8. Able and willing to provide written informed consent.

Exclusion Criteria:

  1. Onset of HD symptoms prior to age of 21 years (juvenile forms of HD).
  2. HD patients presenting rigid akinesia.
  3. Use of other VMAT2 inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine; and use of other antichoreic treatment such as any neuroleptic, or amantadine, memantine, riluzole.
  4. Patients who experienced severe depression or suicide attempt in the last 5 years.
  5. Severe untreated or under-treated psychiatric illness such as active suicidal ideation or behavior or depression.
  6. Patients with a history of, or current, hypotension, bradycardia, or orthostatic hypotension.
  7. Patients with hypertension already treated with more than 2 antihypertensive drugs.
  8. Other active clinically significant illness, which could interfere with the study conduct, counter-indicate the study treatment, place the patient at risk during the trial, or compromise their study participation.
  9. Any significant serious abnormality in the electrocardiogram (ECG), or a known history of long QTc syndrome.
  10. Patients with severe hepatic impairment, or with severe renal impairment, or with any other significant abnormality in the physical examination or clinical laboratory results that, in the Investigator's opinion, would not be compatible with study participation or represent a risk for the patient while in the study.
  11. Females who are pregnant or lactating, or who intend to become pregnant during the study period.
  12. Patients with allergy under desensitization, with known psoriasis, or a known allergy/hypersensitivity to any ingredients of the trial medication or placebo.
  13. History of alcohol or substance abuse in the previous 12 months.
  14. Patients participating in any other study, and the use of any investigational therapy.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05475483


Contacts
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Contact: Aileen Ferré 934020150 ferre@sombiotech.com

Locations
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Sponsors and Collaborators
SOM Innovation Biotech SA
More Information
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Additional Information:

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Responsible Party: SOM Innovation Biotech SA
ClinicalTrials.gov Identifier: NCT05475483    
Other Study ID Numbers: SOMCT03
2021-003453-28 ( EudraCT Number )
First Posted: July 27, 2022    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SOM Innovation Biotech SA:
Huntington
Chorea
SOM3355
Additional relevant MeSH terms:
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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
Bevantolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs