SOM3355
Completed
The main purpose of this trial is to study the efficacy and safety of SOM3355 in patients with Huntington’s disease. SOM3355, which has been used for hypertension, will be looked at in this phase 2b trial to establish if it helps with chorea in HD. 2 doses and a placebo group will receive the drug orally twice a day for 12 weeks. 129 participants will be recruited.
EHA interview Catherine Scart about SOM3355
SOM3355 - The drug for long term chronic treatment of chorea in Huntington's Disease patients
Ages Eligible
for Study:
21 Years and older (adult)
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- 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.
- UHDRS Total maximal chorea (TMC) score ≥10.
- UHDRS Total Functional Capacity (TFC) ≥7.
- Able to walk independently or with minimal assistance.
- Females of child-bearing potential must use a medically accepted effective method of birth control and should not be breast-feeding.
- In the opinion of the Investigator, the patient must have adequate support to comply with the entire study requirements.
- Able and willing to provide written informed consent.
- Onset of HD symptoms prior to age of 21 years (juvenile forms of HD).
- HD patients presenting rigid akinesia.
- 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.
- Patients who experienced severe depression or suicide attempt in the last 5 years.
- Severe untreated or under-treated psychiatric illness such as active suicidal ideation or behavior or depression.
- Patients with a history of, or current, hypotension, bradycardia, or orthostatic hypotension.
- Patients with hypertension already treated with more than 2 antihypertensive drugs.
- 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.
- Any significant serious abnormality in the electrocardiogram (ECG), or a known history of long QTc syndrome.
- 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.
- Females who are pregnant or lactating, or who intend to become pregnant during the study period.
- Patients with allergy under desensitization, with known psoriasis, or a known allergy/hypersensitivity to any ingredients of the trial medication or placebo.
- History of alcohol or substance abuse in the previous 12 months.
- Patients participating in any other study, and the use of any investigational therapy.
LOCATIONS
COUNTRIES
France
- TRIAL SITE:
Centre Hospitalier Universitaire Angers - Address: Angers, France
- TRIAL SITE:
CHU Hôpital Henri Mondor (APHP) - Address: Créteil, France
- TRIAL SITE:
Hôpital Roger Salengro – CHU Lille - Address: Lille, France
- TRIAL SITE:
Hopital de Hautepierre - Address: Strasbourg, France
- TRIAL SITE:
Hôpital Purpan – CHU Toulouse - Address:Toulouse, France
Germany
- TRIAL SITE:
Charité – Universitätsmedizin Berlin - Address: Berlin, Germany
- TRIAL SITE:
George Huntington Institut - Address: Münster, Germany
- TRIAL SITE:
Hospital of University of Ulm - Address: Ulm, Germany
- TRIAL SITE:
kbo-Isar-Amper-Klinikum - Address:München,Germany
Italy
- TRIAL SITE:
IRCCS Istituto delle Scienze Neurologiche di Bologna - Address: Bologna, Italy
- TRIAL SITE:
Azienda Ospedaliera Universitaria Federico II - Address: Napoli, Italy
TRIAL SITE:
IRCCS Casa Sollievo della Sofferenza
Address: Roma, Italy
- TRIAL SITE:
Sant’Andrea University Hospital - Address: Roma, Italy
Poland
- TRIAL SITE:
Krakowska Akademia Neurologii Sp. z o.o. - Address: Kraków, Poland
- TRIAL SITE:
Indywidualna Praktyka Lekarska Daniel Zielonka - Address: Poznań, Poland
Spain
- TRIAL SITE:
Hospital de la Santa Creu i Sant Pau - Address: Barcelona, Spain
- TRIAL SITE:
Hospital Universitario de Cruces - Address: Bilbao, Spain
TRIAL SITE:
Hospital Universitario de Burgos
Address:Burgos, Spain
- TRIAL SITE:
Hospital Ramón y Cajal - Address: Madrid, Spain
Switzerland
- TRIAL SITE:
Universitaetsspital Bern – Inselspital - Address: Bern, Switzerland
United Kingdom
- TRIAL SITE:
Cambridge University Hospitals NHS Foundation Trust Addenbrooke’s Hospital - Address: Cambridge, United Kingdom
- TRIAL SITE:
NIHR Wellcome Trust Manchester Clinical Research Facility - Address: Manchester, United Kingdom
- TRIAL SITE:
Oxford University Hospitals NHS Foundation Trust - Address: Oxford, United Kingdom
