EUCTR2019-001100-38-IT进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study) - M-STAR Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
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
- •Informed Consent
- •a. Subjects must provide a written signed and dated informed consent form/forms prior to the initiation of any protocol required procedures. Only patients with the capacity to understand the nature, significance, and scope of the clinical trial interventions and to express their wishes accordingly may provide consent to participate in the study.
- •b. Caregivers must be willing to sign and date an IRB/EC-approved written informed consent form that outlines the caregiver expectations and responsibilities in this study in accordance with regulatory and institutional guidelines.
- •Age and Sex
- •a. Male and female subjects between the ages of greater than or equal to 40 to less than or equal to 80 years at time of Screening.
- •Target Population
- •a. Diagnosis of probable or possible MSA according to consensus clinical
- •criteria including subjects with MSA of either subtype (MSA-P or MSAC).
- •b. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed.
- •c. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.
- •d. A brain MRI scan (conducted within the 14 days prior to Baseline/Day 1, approximately) that does not rule out a diagnosis of MSA.
- •e. Able to tolerate MRI.
- •f. Body mass index (BMI) < 40 kg/m2 at Screening.
- •g. Able to swallow tablets whole and anticipated to be able to do so throughout the duration of the study.
- •h. Willing and able to adhere to the study drug regimen.
- •i. Willing and able to perform all protocol-specified assessments and comply with the study visit schedule.
- •j. Able to read, understand, and speak local language fluently to ensure comprehension of informed consent and protocol-specified assessments.
- •k. Must have reliable caregiver to accompany subject to all study visits. With the same Caregiver giving caregiver completing assessments at Baseline, Week 24 and Week 48/ Early discontinuation, when possible.
- •Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and protocol-specified assessments. Caregiver must also have frequent contact with subject (at least 3 hours per week at one time or different times) and be willing to monitor the subject's health and concomitant medications throughout the study.
- •l. If subject is receiving treatment for MSA, the doses must have been stable for at least 30 days prior to Baseline/Randomization and medication present at Baseline expected to remain relatively stable during the study period. This may include medications commonly used for Parkinson's disease or those for autonomic dysfunction.
- •m. Stable on other chronic medications and supplements for at least 30 days prior to Baseline/Randomization and expected to remain relatively stable during the study period.
- •n. Women of child bearing potential (WOCBP) and fertile men (including those vasectomized for less than 6 months) with female partners who are WOCBP (not surgically sterile and not post-menopausal) must agree to use highly effective birth control, including two methods og contraception, for the duration of the study (beginning 30 days prior to Baseline/Randomization and extending to 30 days for women and 90 days for men after the last dose of study drug). The two methods of contraception should include:
- •- one barrier method (e.g. diaphragm with spermicide, condom with spermicidal gel, intrauterine contraceptive devices [pl
排除标准
- •Target Disease Exceptions
- •a. Subjects having advanced disease as defined in the protocol.
- •b. Subjects having significant cognitive impairment, defined by a score of less than or equal to 20 on the MoCA
- •Medical History Exclusions
- •a. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
- •b. Diagnosis of neurological disorders, other than MSA as defined in the protocol
- •c. History of or Screening brain MRI scan indicative of significant abnormality.
- •d. Contraindication to MRI examination for any reason.
- •e. For optional CSF sub-study: contraindication to undergoing an LP.
- •f. Presence of clinically significant thyroid disease with abnormal free T4 levels and TSH >10mIU/L (despite treatment) at Screening , confirmed by repeat.
- •g. Within 1 year prior to screening or between screening and Baseline (Day 1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to MSA.
- •h. Diagnosis of clinically significant psychiatric disorder as defined in the protocol.
- •i. History of substance use disorder (drug or alcohol) in the last 12 months, with the exception of nicotine, as defined by DSM-V criteria.
- •j. History or presence of gastrointestinal or other disease known to interfere with absorption, distribution, metabolism, or excretion of drugs, or a history of surgery known to interfere with absorption or excretion of drugs excretion of drugs (i.e. gastric bypass).
- •k. History of any other clinically significant disease that, based on the judgment of the Investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results.
- •l. History of human immunodeficiency virus infection.
- •m. Hematologic or solid malignancy diagnosis within 5 years prior to Screening.
- •n. Any major surgery within 4 weeks of Screening.
- •o. Blood transfusion within 4 weeks of Screening.
- •p. History of brain surgery for Parkinsonism.
- •q. History of stem-cell treatment.
- •r. Women who are pregnant or breastfeeding.
- •s. Subjects or prisoners who are involuntarily detained or incarcerated for treatment of either a psychiatric or physical illness must not be enrolled into the study.
- •t. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
- •Physical and Laboratory Test Findings
- •Please refer to Protocol for other criteria.
研究者
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