EUCTR2013-002899-41-DE进行中（未招募）1 期
A dose escalation, proof of concept, phase IIa study to investigate the safety and tolerability, the pharmacokinetic and thepharmacodynamic of BN82451B, administered twice daily over 4 weeks, in male patients with Huntington’s disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •(1) Male subjects = 20 to = 70 years old.
- •(2) Provision of written informed consent prior to any study related procedures.
- •(3) Confirmed symptomatic HD diagnosed based on clinical features (i.e. Diagnostic Confidence Level = 4) and presence
- •of = 36 CAG repeats in the Huntington gene as documented by a copy of a previous genetic test report.
- •(4) UDHRS-TMS = 15.
- •(5) Ambulatory.
- •(6) UHDRS-Total Functional Capacity (TFC) =3 (i.e. Shoulson & Fahn Scale stages 1-3 inclusive)
- •(7) Subjects on antipsychotic, antidepressant, anxiolytic and hypnotic therapy must have been on stable treatment
- •4 weeks prior to study drug start and during the study period.
- •(8) Able to swallow study medication.
- •(9) Able to perform Q-Motor tests.
- •(10) If his partner is at risk of pregnancy, the subject agrees to use a condom or be abstinent for 14 days after the last intake of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •(1) Juvenile forms of HD.
- •(2) Any form of chorea other than HD.
- •(3) History of seizure, epilepsy or other convulsive disorder.
- •(4) History of conditions susceptible to induce seizures such as severe traumatic brain injury, brain tumours, stroke.
- •(5) History of neurosurgical procedure.
- •(6) Current evidence or history (within 1 year of Baseline) of psychosis, hallucinations or delusions, including major
- •depression with psychotic features, as defined in the Diagnostic and Statistical Manual, Fourth Edition, Text
- •Revision (DSM-IV-TR). Patients currently experiencing mild depression, or moderate depression which is adequately
- •and appropriately treated in the judgement of the investigator, can participate if depression is not expected to
- •interfere with study participation.
- •(7) History of drug and/or alcohol abuse as per the DSM IV-TR criteria within 12 months prior to Baseline.
- •(8) At imminent risk of self harm based on investigator’s clinical judgment, with a yes” answer on item 4 or 5 on the
- •CSSRS questionnaire.
- •(9) Mini Mental State Exam (MMSE) total score = 23.
- •(10) Used any investigational drugs within 30 days prior to Screening or 5 half lives, whichever is the longest.
- •(11) Known allergy/sensitivity to the study drugs or their excipients.
- •(12) A severe or ongoing unstable medical condition (e.g. cardiac, hepatic, renal, metabolic or endocrine).
- •(13) Any clinically significant condition which, in the opinion of the investigator, would interfere with the trial evaluations or
- •optimal participation in the trial.
- •(14) Any significant laboratory results which, in the investigator’s opinion, would not be compatible with study
- •participation or represent a risk for subjects while in the study.
- •(15) History of malignant disease within the 5 years prior to Screening (with the exception of basal cell and squamous
- •cell carcinomas of the skin that have been completely excised, in situ prostate cancer with a normal prostate
- •specific antigen).
- •(16) An estimated Creatinine Clearance (CrCl) of <60 mL/minute (using the Cockcroft-Gault formula).
- •(17) ALT or AST values =2x the Upper Limit of Normal range (ULN) or both or both GGT and ALP >3x ULN
- •(18) Known history of hepatitis B or C or Human Immunodeficiency Virus (HIV) or positive serology at
- •(19) Corrected QT interval using Bazett's correction (QTcB) >450 ms or other clinically significant ECG findings.
- •(20) Receiving tetrabenazine within 4 weeks prior to Baseline
- •(21) Receiving drugs at doses known to induce seizures with an incidence of more than 1% as per the reference list
- •(22) Taking the following prohibited medications/substances: Strong Cytochrome (CYP) 3A4 inhibitors, strong CYP3A4 inducers and CYP2B6 substrates (Wash out prior to Baseline 30 days or 5 half lives,whichever is the longest). CYP1A2 substrates, CYP3A4 substrates and CYP2C19 substrates may be allowed and will be assessed on a case by case basis according to the dose received.
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