Clinical trial NCT01521585 (phase 2, status: completed)
Conditions: huntington's disease
ICD codes: G10
Drugs: sen0014196, sen0014196, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Genetically confirmed, manifest HD (CAG repeat length ≥ 36) and motor signs of HD
             (including motor score of the UHDRS ≥ 5).

          -  Clinical Stages I to III (Total Functional Capacity Subscale Score [TFC] of ≥ 3).

          -  Patients must be anticipated to be ambulatory and able to attend outpatient visits for
             the duration of the study.

          -  Patients must be aged ≥ 30 years and ≤ 70 years.

          -  Body mass index between 18 and 31 kg/m2 inclusive, and a body weight greater than 50
             kg.

          -  Patients must be able to give informed consent or have a legal representative who can
             consent on their behalf. Patients must be able to comply with trial procedures.

          -  Patients must have no clinically significant and relevant medical or psychiatric
             history that could affect the conduct of the study and evaluation of the data, as
             ascertained by the Investigator through detailed medical history and screening
             assessments.

          -  Male patients must agree to use condoms during the entire duration of the study and
             for 3 months following the last dose of study drug.

          -  Females of childbearing potential (last menses less than 1 year prior to enrolment).

        Exclusion Criteria:

          -  Participation in a study with an investigational drug within 30 days of the Baseline
             Visit.

          -  Any prior or concomitant use of Class I or Class II histone deacetylase (HDAC)
             inhibitors such as Zolinza®/vorinostat or belinostat.

          -  Clinical evidence of significant or unstable medical illness in the Investigator's
             judgement, including screening transaminases (AST or ALT) ≥ 3 times the upper limit of
             normal (ULN), or an estimated GFR < 60 mL/min, or unexplained proteinuria or
             microscopic haematuria in an uncontaminated sample obtained at Screening and confirmed
             on repeat testing.

          -  QTcF interval >450 ms in men and >470 ms in women or PR >220 ms, or other clinically
             relevant abnormal ECG findings

          -  Women who are pregnant or breastfeeding.

          -  Clinically significant abnormalities in the screening laboratory studies which, in the
             opinion of the Investigator, would interfere with participation in the study.

          -  Current evidence or history (within 1 year of baseline) of psychosis, hallucinations
             or delusions, including major depression with psychotic features, as defined in the
             DSM-IV-TR. Patients currently experiencing mild depression, or moderate depression
             which is adequately and appropriately treated in the judgment of the Investigator, can
             participate if depression is not expected to interfere with study participation.

          -  Suicide risk, as determined by meeting any of the following criteria:

               -  A suicide attempt within the past year or suicidal ideation within 60 days of the
                  Baseline Visit (Day 1).

               -  Significant risk of suicide, as judged by the Principal Investigator, based on
                  the psychiatric interview or information collected in the C-SSRS.

          -  Current diagnosis or history (within 1 year of baseline) of any alcohol or substance
             abuse (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.

          -  Known allergy to any ingredient in the study drug (active and/or placebo).

          -  A history of malignancy of any type within 2 years prior to screening. A history of
             surgically excised non-melanoma skin cancers is permitted.

          -  Any relevant condition, behaviour, laboratory value, or concomitant medication which,
             in the opinion of the Investigator, makes the patient unsuitable for entry into the
             study.