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A Phase II Safety and Tolerability Study With SEN0014196

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521585
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : November 25, 2015
Information provided by (Responsible Party):
Siena Biotech S.p.A.

Brief Summary:
The principal aim of this study is to obtain safety and tolerability data when SEN0014196 is administered orally over 12 weeks to male and female patients with Huntington's Disease.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: SEN0014196 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study in Huntington's Disease Patients to Determine the Safety and Tolerability of SEN0014196
Study Start Date : November 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SEN0014196 50 mg oral tablet Drug: SEN0014196
50 mg oral once daily tablet

Experimental: SEN0014196 200 mg oral tablet Drug: SEN0014196
200 mg oral once daily tablet

Placebo Comparator: Placebo tablet Drug: Placebo
oral once daily tablet

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 12 weeks ]
    Adverse event (AE) reporting, 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and laboratory safety tests. Suicide risk (Columbia Suicide Severity Rating Scale,C-SSRS).

Secondary Outcome Measures :
  1. Short-term clinical effects [ Time Frame: 12 weeks ]
    Global Clinical Impression (GCI, patient and clinician-based), UHDRS, Total Motor Scale (UHDRS-TMS), Functional Assessment, Independence Scale Assessment, Problem Behaviours Assessment, Cognitive Battery (Symbol Digit Modalities Test, Stroop Word Test, Verbal fluency, Mini-Mental State Examination [MMSE]).

  2. Modulation of candidate pharmacodynamic markers [ Time Frame: 12 weeks ]
    Acetylation status of mutant huntingtin, levels of soluble huntingtin.

  3. Pharmacokinetic profile [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521585

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Dept. of Neurology, University of Münster
Münster, Germany, 48149
Sponsors and Collaborators
Siena Biotech S.p.A.
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Principal Investigator: Ralf Reilmann, MD Dept. of Neurology, University of Münster - Germany

Additional Information:
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Responsible Party: Siena Biotech S.p.A. Identifier: NCT01521585    
Other Study ID Numbers: S015-002
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders