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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEN0014196 50 mg oral tablet | Experimental |
| |
| SEN0014196 200 mg oral tablet | Experimental |
| |
| Placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEN0014196 | Drug | 50 mg oral once daily tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term clinical effects | 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]). | 12 weeks |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Reilmann, MD | Dept. of Neurology, University of Münster - Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Neurology, University of Münster | Münster | 48149 | Germany |
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| Label | URL |
|---|---|
| The European Huntington's Disease Network | View source |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C550547 | 6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide |
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| SEN0014196 |
| Drug |
200 mg oral once daily tablet |
|
| Placebo | Drug | oral once daily tablet |
|
| Modulation of candidate pharmacodynamic markers | Acetylation status of mutant huntingtin, levels of soluble huntingtin. | 12 weeks |
| Pharmacokinetic profile | 12 weeks |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |