SOM3355

Recruiting

SPONSOR

SOM Biotech

PARTICIPANTS

129

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.

Catherine Scart presents updates on SOM3355

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
  • Principal investigator: Pr. Christophe Verny
  • Contact: +33 241355615

Recruiting

  • TRIAL SITE:
    CHU Hôpital Henri Mondor (APHP)
  • Address: Créteil, France
  • First investigator: Dr. Katia Youssov (NC)
  • Contact: +33 1 49 81 37 93

Recruiting

  • TRIAL SITE:
    Hôpital Roger Salengro – CHU Lille
  • Address: Lille, France
  • First investigator: Dr. Clemence Simonin
  • Contact: +33 320445962 poste 30583

Recruiting

  • TRIAL SITE:
    Hopital de Hautepierre
  • Address: Strasbourg, France
  • Principal investigator: Pr. Christine Tranchant
  • Contact: +33 3 88 12 86 42

Recruiting

  • TRIAL SITE:
    Hôpital Purpan – CHU Toulouse
  • Address:Toulouse, France
  • Principal investigator: Pr. Jérémie Pariente
  • Contact: +33 5 61 77 91 14

Not recruiting yet

Germany

  • TRIAL SITE:
    Charité – Universitätsmedizin Berlin
  • Address: Berlin, Germany
  • Principal investigator: Prof Dr. Josef Priller
  • Contact: +49 30 450 617 236

Not recruiting yet

  • TRIAL SITE:
    George Huntington Institut
  • Address: Münster, Germany
  • Principal investigator: Dr. Ralf Reilmann
  • Contact: +49-251-788-788-0

Not recruiting yet

  • TRIAL SITE:
    Hospital of University of Ulm
  • Address: Ulm, Germany
  • Principal investigator: Prof Dr. Jan Lewerenz
  • Contact: +49 731 500 63083

Not recruiting yet

Italy

  • TRIAL SITE:
    IRCCS Istituto delle Scienze Neurologiche di Bologna
  • Address: Bologna, Italy
  • Principal investigator: Pietro Cortelli
  • Contact: +39 0514966919

Not recruiting yet

  • TRIAL SITE:
    Azienda Ospedaliera Universitaria Federico II
  • Address: Napoli, Italy
  • Principal investigator: Elena Salvatore

Not recruiting yet

TRIAL SITE:
IRCCS Casa Sollievo della Sofferenza

Address: Roma, Italy

Recruiting

  • TRIAL SITE:
    Sant’Andrea University Hospital
  • Address: Roma, Italy
  • Principal investigator: Giovanni Ristori

Not recruiting yet

Poland

  • TRIAL SITE:
    Krakowska Akademia Neurologii Sp. z o.o.
  • Address: Kraków, Poland
  • Principal investigator: Prof. Monika Rudzińska-Bar
  • Contact: 48 663 506 016

Recruiting

  • TRIAL SITE:
    Indywidualna Praktyka Lekarska Daniel Zielonka
  • Address: Poznań, Poland
  • Principal investigator: Dr. Daniel Zielonka
  • Contact: 48 798-870-488

Not recruiting yet

Spain

  • TRIAL SITE:
    Hospital de la Santa Creu i Sant Pau
  • Address: Barcelona, Spain
  • Principal investigator: Dr. Jaime Kulisevsky (CI)
  • Contact: +34 649 14 23 60

Recruiting

  • TRIAL SITE:
    Hospital Universitario de Cruces
  • Address: Bilbao, Spain
  • Principal investigator: Dr. Tamara Fernandez Valle
  • Contact: +34 644819239

Recruiting

TRIAL SITE:
Hospital Universitario de Burgos

Address:Burgos, Spain

Recruiting

  • TRIAL SITE:
    Hospital Ramón y Cajal
  • Address: Madrid, Spain
  • Principal investigator: Dr Jose Luis Lopez-Sendón Moreno
  • Contact: +34 91 336 82 63

Recruiting

  • TRIAL SITE:
    Hospital Universitario de Burgos
  • Address: Burgos, Spain
  • Principal investigator: Esther Cubo
  • Contact: +34 638783683 

Switzerland

  • TRIAL SITE:
    Universitaetsspital Bern – Inselspital
  • Address: Bern, Switzerland
  • Principal investigator: Prof. Michael Orth
  • Contact: +41 31 352 20 70

Not recruiting yet

United Kingdom

  • TRIAL SITE:
    Cambridge University Hospitals NHS Foundation Trust Addenbrooke’s Hospital
  • Address: Cambridge, United Kingdom
  • Principal investigator: Prof. Roger Barker
  • Contact: +44 (0) 7720612637

Not recruiting yet

  • TRIAL SITE:
    NIHR Wellcome Trust Manchester Clinical Research Facility
  • Address: Manchester, United Kingdom
  • Principal investigator: Dr David Craufurd
  • Contact: +44 (0) 161 906 7540

Not recruiting yet

  • TRIAL SITE:
    Oxford University Hospitals NHS Foundation Trust
  • Address: Oxford, United Kingdom
  • Principal investigator: Dr Richard Armstrong
  • Contact: +44 (0) 7768864833

Not recruiting yet

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dictionary:

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.

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Inclusion Criteria

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.

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CAG repeat

The stretch of DNA at the beginning of the HD gene, which contains the sequence CAG repeated many times, and is abnormally long in people who will develop HD. (from HDbuzz.org)

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Exclusion Criteria

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.