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| ID | Type | Description | Link |
|---|---|---|---|
| CTA Number: 2010-021563-32 | Other Grant/Funding Number | European Commission 7th Framework Programme |
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| Name | Class |
|---|---|
| Seventh Framework Programme | OTHER |
| European Huntington's Disease Network | NETWORK |
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The primary objective of this study is to provide biological samples from patients with Huntington's disease to allow characterisation of the pharmacological mechanism of action of SEN0014196.
This study will establish the acute phenotypical and biological effects of repeated dose application of SEN0014196 in patients with Huntington's disease, providing biomaterials for biomarker studies (levels of circulating huntingtin, acetylation status of mutant huntingtin, innate immune markers, transcriptional profiles). Evaluation of phenotypic effects will include UHDRS scores, total functional capacity. Safety assessments will include ECG, vital signs, laboratory safety tests and physical examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEN0014196 (Low Dose) | Experimental | 10 mg, once daily administration (immediate release capsule) |
|
| SEN0014196 (High dose) | Experimental | 100 mg, once daily administration (immediate release capsule) |
|
| Placebo | Placebo Comparator | Once daily (immediate release capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEN0014196 (Low Dose) | Drug | 10 mg once daily administration (immediate release capsule) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the change from baseline of a series of pharmacodynamic markers in peripheral blood mononuclear cells | Collection of peripheral blood mononuclear cells for biomarker investigations, specifically acetylation status of mutant huntingtin, levels of circulating huntingtin, innate immune markers and transcriptional profiles | Baseline, Day 7, Day 14, Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability following repeated doses of SEN0014196 over two weeks at two dose levels in patients with Huntington's disease | Safety assessments will include ECG, vital signs, laboratory safety tests, and physical and neurological examination. Tolerability will include type and frequency of adverse events. | Baseline, Day 7, Day 14, Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard G Landwehrmeyer, MD, PhD | European Huntington's Disease Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Ulm, Neurologie | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D003072 | Cognition Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019965 | Neurocognitive Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C550547 | 6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide |
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| SEN0014196 (High Dose) | Drug | 100 mg once daily administration (immediate release capsule) |
|
| Placebo | Drug | Once daily administration (immediate release capsule) |
|
| To determine the pharmacokinetics of repeated doses of SEN0014196 at two dose levels when administered over two weeks in patients with Huntington's disease | The following parameters will be assessed: maximum observed plasma concentration (Cmax), time of maximum observed plasma concentration(tmax), AUC from time zero to the length of the dosing interval (tau) (AUC0-τ), AUC from time zero to the last quantifiable concentration (AUC0-last), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2), and terminal elimination rate constant (λz). Gender differences. Dose proportionality. | Baseline, Day 14 |
| D013568 | Pathological Conditions, Signs and Symptoms |