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.

SOM Innovation Biotech SA (SOM Biotech)0 sites129 target enrollmentMarch 17, 2022

ConditionsHuntington’s Disease with choreic movements.MedDRA version: 20.0Level: LLTClassification code 10020469Term: Huntington's choreaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsCalvan Tablets 100

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Huntington’s Disease with choreic movements.
Sponsor: SOM Innovation Biotech SA (SOM Biotech)
Enrollment: 129
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 17, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

SOM Innovation Biotech SA (SOM Biotech)

Eligibility 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 cytosine\-adenosine\-guanine (CAG) repeats \=36\.
•3\.UHDRS Total maximal chorea (TMC) score \=10\.
•4\.UHDRS Total Functional Capacity (TFC) \=7 (corresponding to mildly to moderately impaired patients).
•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, agree to continue this method for the duration of the study and for at least 1 month following the last dose of study drug, and be negative to serum pregnancy test performed at the screening visit (Refer to section 5\.4 for complete advice on contraceprtion requirements of this study). Female patients 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 as described in this protocol (e.g. transportation to and from the trial site, self\-rating scales, drug compliance, scheduled visits, etc.).
•8\.Able and willing to provide written informed consent prior to any study\-related procedure being performed at the screening visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\.Onset of HD symptoms prior to age of 21 years, corresponding to juvenile forms of HD.
•2\.HD patients presenting rigid akinesia.
•3\.Use of other vesicular monoamine transporter type 2 (VMAT2\) inhibitors such as tetrabenazine, deutetrabenazine, or valbenazine within 3 months before enrollment, and at any time during the study period; and use of other antichoreic treatment such as any neuroleptic within 2 months or amantadine, memantine, riluzole within 1 month before enrollment and along the study.
•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 (BDI\-21 item \#9 \>0 and active suicidal ideation in C\-SSRS) or depression at screening and/or initiation visit (BDI\-21 items total score \>30\); although patients taking authorized antidepressant therapy at a stable dose for at least 2 months and stabilized can be enrolled.
•6\.Patients with a history of, or current, hypotension (SBP \<110 mmHg), bradycardia (HR \<50 bpm), or orthostatic hypotension as defined by the European Society of Hypertension (reduction in SBP \=20 mmHg or in DBP \=10 mmHg).
•7\.Patients with hypertension already treated with more than 2 antihypertensive drugs.
•8\.Other active clinically significant illness, including unstable cardiovascular disease, angina pectoris, congestive heart failure, pulmonary hypertension, peripheral arterial disease, history of pheochromocytoma, asthma, history of bronchospasm, COPD, diabetic ketoacidosis or metabolic acidosis, or neoplastic pathology, which could interfere with the study conduct, or counter\-indicate the study treatment, or to place the patient at risk during the trial, or compromise their study participation.
•9\.Any significant serious abnormality in the electrocardiogram (ECG), e.g. recent myocardial infarction, significant sinus bradycardia (\<50 bpm), atrioventricular block (grades I to III with PR \>240msec), sinoatrial block, atrial sinus disease or prolonged QTc interval at screening (ECG Bazett’s corrected QT interval (QT /v \[HR/60] \>450 msec for males or \>460 msec for females), or a known history of long QTc syndrome.
•10\.Patients with severe hepatic impairment (AST or ALT\=10 x upper limit of normal (ULN), or with severe renal impairment (creatinine clearance (CLcr) \= 30 mL/min as calculated by the Cockcroft\-Gault equation), 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.