CTIS2023-504876-12-00招募中1 期
A Phase 3, Multi-center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy - 0197
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participant is male or female and at least 30 years old., Participant is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures., Participant is able to communicate well with the Investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions., Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008)., Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) confirmed by the Enrollment Steering Committee (ESC)., Participant must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of =20 mmHg (systolic) or =10 mmHg (diastolic) within 3 min of standing as part of the orthostatic standing test or being tilted up =60 degrees from a supine position as determined by a tilt-table test., Participant must score =4 on UMSARS Part IV at Visit 1 (Screening)., Participant must score at least a 4 on the OHSA item 1 at Visit 2 (Day 1)., Participant must be willing to not take any prohibited medications during the study., If participant is female, the participant must not be pregnant, breastfeeding, or planning a pregnancy during the course of the study. A woman of childbearing potential must have a documented negative pregnancy test at screening. NOTE: A woman is considered to be of childbearing potential unless she is postmenopausal (amenorrheic for at least 2 years) or documented to be surgically sterile (bilateral tubal ligation or total hysterectomy). A female participant may be admitted to the study on the basis of a negative urine pregnancy test. If the urine beta human chorionic gonadotropin (bHCG) test is positive, a serum bHCG test must be performed. The pregnancy test must be confirmed negative for a participant to be eligible for this study., During the study and for 30 days after receiving the last dose of the study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse (Refer to Section 4.3 of the protocol for more information).
排除标准
- •Participant has a systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Participant with diabetes mellitus (DM) will be evaluated on a case-by-case basis by the medical monitor and considered ineligible unless they meet all of the following criteria: a. Well controlled type-2 DM in treatment with only oral medications and diet b. HbA1C of =7.5% performed during screening or up to 12 weeks before screening c. No clinically evident peripheral neuropathy (e.g., normal sensory examination on peripheral extremities) d. No known retinopathy (e.g., annual ophthalmic exam is sufficient) e. No nephropathy (e.g., absence of albuminuria and GFR >60), Participant is currently receiving any investigational drug or has received an investigational drug within 30 days prior to Screening or within 5X the half-life of the investigational drug, whichever is longer. An investigational drug is defined as a drug that is not approved by a regulatory agency (e.g., Food and Drug Administration [FDA])., Participant has a clinically significant abnormal laboratory finding(s) (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] =3.0 x upper limit of normal [ULN]; blood bilirubin [total] =3.0 x ULN; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any abnormal laboratory value that could interfere with safety of the participant)., Participant has a known intolerance to other norepinephrine reuptake inhibitors (NRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)., Participant has demonstrated lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Baseline/Screening Version). Participant should be assessed by the rater for risk of suicide and the participant’s appropriateness for inclusion in the study., Participant has a concurrent disease or condition (e.g., COVID-19), or recent surgery, that in the opinion of the Investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or absorption of the study drug., Participant has known hypersensitivity to ampreloxetine (ampreloxetine hydrochloride), or any excipients in the formulation., Major surgery (i.e., procedures involving higher risk for infection and extended recovery period, such as, joint replacement, gastric bypass, open heart surgery, organ transplant, etc.) occurring less than 4 weeks prior to enrollment., Participant currently uses concomitant antihypertensive medication for the treatment of essential hypertension., Participant has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to Visit 2 (Day 1) or requires concomitant use until the Safety Follow-up Visit., Participant has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to Visit 2 (Day 1). • Midodrine and droxidopa (if applicable) must be tapered off and stopped at least 7 days prior to Visit 2 (Day 1)., Participant has used any monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 (Day 1)., Participant has known or suspected alcohol or substance abuse within the past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR®] definition of alcohol or substance abuse)., Participant has clinically unstable coronary artery disease or had a major cardiovascular event (e.g., myocardial infarction) in t
研究者
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