Huntington's Disease with choreic movements. MedDRA version: 20.0 Level: LLT Classification code 10020469 Term: Huntington's chorea System Organ Class: 100000004850
Conditions
Interventions
Trade Name: Calvan (bevantolol hydrochloride)
Product Name: SOM3355 (bevantolol hydrochloride)
Product Code: [SOM3355]
Pharmaceutical Form: Capsule
INN or Proposed INN: BEVANTOLOLO CLORIDRATO
CAS Numb
Sponsors
SOM Innovation Biotech S.A.
Eligibility
Sex/Gender
All
Inclusion 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 be negative to serum pregnancy test performed at the screening visit. 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
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 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 >470 msec for females), 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, within 1 month prior to entry in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of two doses of SOM3355 (400 mg/day and 600 mg/day taken twice daily [BID] over at least 8 weeks at maintenance dose) compared to placebo to reduce chorea in HD patients measured by the change in TMC score (primary efficacy endpoint).;Secondary Objective: To evaluate the safety and tolerability of two doses of SOM3355 (400 mg/day and 600 mg/day taken) compared with placebo in HD patients, with particular attention to depression and suicidality and to the cardiovascular hemodynamic parameters. And to evaluate the efficacy of the two doses of SOM3355 (400 mg/day and 600 mg/day taken BID) compared with placebo on:the change of Clinical Global Impression (CGI C), the change of Patient Global Impression (PGI-C), the percentage of responders based on the improvement =2 in TMC score, the percentage of change of TMC score.;Primary end point(s): Change in Total Maximal Chorea (TMC) sub-score of the Unified Huntington's Disease Rating Scale (UHDRS);Timepoint(s) of evaluation of this end point: Between baseline and end of maintenance dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change from baseline in the Clinical Global Impression (CGI-C). •Change from baseline in the Patient Global Impression (PGI-C). •TMC-response defined as improvement =2 in TMC score between baseline and end of maintenance dose. •Percentage of change in TMC score between baseline and the end of maintenance dose. •Change from baseline in Total Motor Score (TMS) of the UHDRS. •Change from baseline in Gait sub-score of the UHDRS. •Change from baseline in Dystonia sub-score of the UHDRS. •Change from baseline in EQ5D-5L measuring quality of life.;Timepoint(s) of evaluation of this end point: Between baseline and end of maintenance dose | — |
Countries
France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
SOM Innovation Biotech SA (SOM Biotech)
Outcome results
None listed