SEN0014196 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病7

8. ハンチントン病


臨床試験数 : 229 薬物数 : 193 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT01485965
(ClinicalTrials.gov)
November 201129/11/2011A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington DiseaseA Phase 1b, Open-label, Parallel-group Study in Subjects With Huntington Disease to Assess the Safety, Tolerability, and Fed/Fasted Pharmacokinetics of Repeated Oral Doses of SEN0014196Huntington's DiseaseDrug: SEN0014196Siena Biotech S.p.A.NULLCompleted25 Years65 YearsBoth26Phase 1United States
2NCT01521585
(ClinicalTrials.gov)
November 201126/1/2012A Phase II Safety and Tolerability Study With SEN0014196A Double-blind, Placebo-controlled Study in Huntington's Disease Patients to Determine the Safety and Tolerability of SEN0014196Huntington's DiseaseDrug: SEN0014196;Drug: PlaceboSiena Biotech S.p.A.NULLCompleted30 Years70 YearsBoth144Phase 2Germany
3EUCTR2011-001131-23-GB
(EUCTR)
24/10/201118/07/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington’s Disease patients to determine the safety and tolerability of SEN0014196 - N/A Huntington's disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Siena Biotech SpANULLNot RecruitingFemale: yes
Male: yes
144Germany;Italy;United Kingdom
4EUCTR2011-001131-23-IT
(EUCTR)
20/10/201122/11/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington's Disease patients to determine the safety and tolerability of SEN0014196 Huntington's disease
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.0;Level: LLT;Classification code 10020469;Term: Huntington's chorea;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
SIENA BIOTECH SPANULLNot RecruitingFemale: yes
Male: yes
144Germany;United Kingdom;Italy
5EUCTR2011-001131-23-DE
(EUCTR)
21/09/201127/06/2011A study to determine how safe and tolerable the study drug is, when given to patients with Huntingtons Disease.A double-blind, placebo-controlled study in Huntington’s Disease patients to determine the safety and tolerability of SEN0014196 - N/A Huntington's disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Product Name: SEN0014196
Product Code: SEN0014196
INN or Proposed INN: selisistat
Siena Biotech SpANULLNot RecruitingFemale: yes
Male: yes
144Germany;Italy;United Kingdom
6NCT01485952
(ClinicalTrials.gov)
March 201129/11/2011An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients to Assess Pharmacokinetics, Candidate Pharmacodynamic Measures of Target Engagement and Disease Modulation as Well as Acute Phenotypical Effects Following Multiple Oral Doses of SEN0014196.Huntington DiseaseDrug: SEN0014196 (Low Dose);Drug: SEN0014196 (High Dose);Drug: PlaceboSiena Biotech S.p.A.Seventh Framework Programme;European Huntington's Disease NetworkCompleted18 Years70 YearsBoth55Phase 1Germany
7NCT01521832
(ClinicalTrials.gov)
October 200913/1/2012Escalating Dose Study in Healthy Volunteers With SEN0014196A Phase I, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study Consisting of Single and Multiple Oral Dose Escalation to Determine, Safety, Tolerability and Pharmacokinetics of SEN0014196Huntington's DiseaseDrug: SEN0014196Siena Biotech S.p.A.NULLCompleted18 Years65 YearsBoth88Phase 1United Kingdom