8. ハンチントン病 Huntington disease Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01521585 (ClinicalTrials.gov) | November 2011 | 26/1/2012 | A Phase II Safety and Tolerability Study With SEN0014196 | A Double-blind, Placebo-controlled Study in Huntington's Disease Patients to Determine the Safety and Tolerability of SEN0014196 | Huntington's Disease | Drug: SEN0014196;Drug: Placebo | Siena Biotech S.p.A. | NULL | Completed | 30 Years | 70 Years | Both | 144 | Phase 2 | Germany |
| 2 | NCT01485965 (ClinicalTrials.gov) | November 2011 | 29/11/2011 | A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease | A 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 SEN0014196 | Huntington's Disease | Drug: SEN0014196 | Siena Biotech S.p.A. | NULL | Completed | 25 Years | 65 Years | Both | 26 | Phase 1 | United States |
| 3 | EUCTR2011-001131-23-GB (EUCTR) | 24/10/2011 | 18/07/2011 | A 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 SpA | NULL | Not Recruiting | Female: yes Male: yes | 144 | Germany;Italy;United Kingdom | |||
| 4 | EUCTR2011-001131-23-IT (EUCTR) | 20/10/2011 | 22/11/2011 | A 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 SPA | NULL | Not Recruiting | Female: yes Male: yes | 144 | Germany;United Kingdom;Italy | |||
| 5 | EUCTR2011-001131-23-DE (EUCTR) | 21/09/2011 | 27/06/2011 | A 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 SpA | NULL | Not Recruiting | Female: yes Male: yes | 144 | Germany;Italy;United Kingdom | |||
| 6 | NCT01485952 (ClinicalTrials.gov) | March 2011 | 29/11/2011 | An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196 | An 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 Disease | Drug: SEN0014196 (Low Dose);Drug: SEN0014196 (High Dose);Drug: Placebo | Siena Biotech S.p.A. | Seventh Framework Programme;European Huntington's Disease Network | Completed | 18 Years | 70 Years | Both | 55 | Phase 1 | Germany |
| 7 | NCT01521832 (ClinicalTrials.gov) | October 2009 | 13/1/2012 | Escalating Dose Study in Healthy Volunteers With SEN0014196 | A 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 SEN0014196 | Huntington's Disease | Drug: SEN0014196 | Siena Biotech S.p.A. | NULL | Completed | 18 Years | 65 Years | Both | 88 | Phase 1 | United Kingdom |