EUCTR2014-004902-13-FI进行中（未招募）1 期
A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- All
入选标准
- •1. Males or females, aged 30-80 years.
- •2. Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008).
- •3. High-affinity binder” or mixed-affinity binder” for TSPO, confirmed by prospective genotyping of TSPO polymorphism.
- •4. Female subjects of childbearing potential must:
- •a. Have a negative serum ß-hCG pregnancy test result at screen and a negative urine ß-hCG test result at baseline, and
- •b. Agree not to become pregnant during participation in the study, and
- •c. Agree, if sexually active, to routinely use two methods of contraception during the study, for 40 days after the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28. One method must be a medically approved contraceptive. The other method must be condom use. Hormonal contraceptives sensitive to CYP3A4 induction are not permitted as a method of
- •contraception.
- •5. Postmenopausal females must have follicle-stimulating hormone (FSH) = 38 mIU/mL at screen.
- •6. Males must agree to refrain from donating sperm during the study, for 100 days following the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28. Sexually active male subjects must:
- •a. Agree to use condoms during the study, for 100 days after the last dose of AZD3241, and for 3 months after the last administration of [11C]PBR28.
- •b. Agree to ensure that they and their partners are routinely using a
- •medically approved contraceptive method.
- •7. Medical treatment of MSA and co-morbid medical conditions must be
- •stable for at least 30 days prior to screen and between screen and
- •baseline (Day -1). Intermittently administered treatment may be
- •considered stable if the dose and dosing frequency have been unchanged
- •for the greater of 30 days or three dosing intervals (e.g., a treatment
- •given once a month must be at a stable dose and dosing frequency for 3
- •8. Able to swallow tablets whole.
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •-Prior participation in any AZD3241 studies
- •-MRI performed during screen not consistent with MSA diagnosis
- •-ET scan or other procedure with administration of a radiopharmaceutical in the last 12 months
- •-Negative Allen test in both hands unless brachial artery used for
- •arterial cannulation
- •- Subjects determined as low affinity binders by TSPO genotyping
- •- Claustrophobia contraindicating brain MRI or PET scans
- •-Pregnancy, lactation or positive serum ß-hCG at screen or positive
- •urine ß-hCG at baseline
- •- Initiation or change in pharmacologic therapy for MSA symptoms
- •within 30 days prior to screen or between screen and baseline
- •- Other significant neurological disease affecting CNS , that may affect
- •motor or autonomic function or ability to complete the study including
- •Alzheimer's, idiopathic Parkinson's, other Parkinson plus syndromes or
- •secondary parkinsonism
- •- History of brain surgery for parkinsonism
- •- History of stem cell treatment
- •- Seizure disorder unless well controlled, for which treatment has been stable for at least 30 days prior to screen and between screen and
- •- Presence of any clinically significant medical condition that is clinically
- •unstable, is likely to deteriorate during the study, could put the patient
- •at risk because of participation, affect ability to complete the study or
- •influence study results
- •- History or presence of thyroid disease
- •- An abnormal TSH or FT4 test result at screen or baseline
- •- History or presence of GI or other disease or history of surgery known
- •to interfere with absorption, distribution, metabolism, or excretion of drugs
- •- Evidence of acute suicidal ideationHistory of suicidal behavior
- •- History of alcohol, drug abuse, dependence (except nicotine
- •dependence) within 1 year prior to screen
- •- Urine drug screen positive for a drug of abuse.
- •- Myocardial infarction; hospitalization for congestive heart failure or
- •symptoms of unstable angina; syncope not related to MSA within 1 year
- •prior to screen or between screen and baseline
- •- Moderate or severe congestive heart failure or known ejection fraction
- •- History or presence of renal disease or impaired renal function
- •- Estimated creatinine clearance < 60 mL/min according to the
- •Cockcroft-Gault equation at screen
- •- A QT interval corrected by the Fridericia procedure (QTcF) > 450 msec at screen (single ECG measurement) or baseline (Day -1) (mean of three
- •ECG measurements), or a family history of long-QT syndrome
- •- Uncontrolled hypertension, 2 or more systolic readings > 220 mmHg or
- •diastolic readings > 105 mmHg
- •- History or presence of diabetes unless glucose levels have been well
- •controlled and treatment has been stable for at least 30 days prior to
- •screen and between screen and baseline
- •- HbA1c = 6.5% at screen
- •- Clinically significant infection within 30 days prior to screen or
- •between screen and baseline
- •- History of cancer within the last 5 years except nonmetastatic basal
- •cell skin carcinoma
- •- Any clinically important abnormality on physical examination or vital
- 另有 7 项未显示
研究者
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