NCT05636852终止2 期
An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
研究概览
简要总结
Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study determined if a lower dose (5 millicuries) would suffice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Part 1: a) the participant had a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that showed normal striatal uptake and b) the participant had a clinical diagnosis (made by a board-certified neurologist who was qualified by training and experience in the diagnosis of movement disorders) that was consistent with the DaTscan image.
- •For Part 2 (which was not conducted): a) the participant had a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that showed abnormal (unilateral or bilateral reduced) striatal uptake and b) the participant also had a confirmed clinical diagnosis of a dPS (such as Parkinson's disease, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, etc.) made by a board-certified neurologist who was qualified by training and experience in the diagnosis of movement disorders, and c) the diagnosis was consistent with the DaTscan image.
- •The participant was male or female, ≥18 years of age, of any race and ethnicity.
- •The participant was able and willing to comply with study procedures and signed and dated informed consent was obtained.
- •If the participant was a woman of childbearing potential*, she must have used a highly effective method of contraception** from Screening until 30 days after the last administration of Altropane, and the results of a serum or urine human chorionic gonadotropin (hCG) pregnancy test, performed at Screening and on the day of Altropane administration (with the result known before Altropane administration), must have been negative.
- •* A woman of childbearing potential was defined as neither post-menopausal nor surgically sterile. Post-menopausal means having had no menses for at least 12 months without an alternative medical cause. Surgically sterile means having had a documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or any combination of these.
- •** A highly effective method of contraception was defined as one that had a failure rate of less than 1% per year when used consistently and correctly; such methods included combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/occlusion; vasectomized partner (with medical confirmation of success); and abstinence from heterosexual intercourse involving a woman of childbearing potential.
- •If the participant was a male*** with a sexual partner who was a woman of childbearing potential*, he and his partner must have used adequate contraception** from Screening until 30 days after the last administration of Altropane.
- •(***A male was considered fertile after puberty unless permanently sterile by bilateral orchidectomy, or vasectomized with confirmation of success.)
排除标准
- •The participant was previously included in this study.
- •Fewer than 7 disintegration half-lives had elapsed between the participant's last procedure (therapeutic or diagnostic) involving a radioisotope and Visit 2 (altropane SPECT imaging).
- •Including participation in this study, the participant's total exposure to radiation during medical procedures/tests in the past year would have exceeded 50 mSv.
- •The participant had participated in an investigational drug or device clinical trial within 30 days before the date of informed consent.
- •The participant had any clinically significant or unstable physical or psychological illness, structural brain abnormality, abnormal laboratory results, or abnormal ECG (based on medical history or physical examination at Screening), as determined by the Principal Investigator, that would interfere with study participation.
- •The participant had any history of drug or alcohol abuse in the 2 years prior to the date of informed consent.
- •The participant had a positive urine screen for drugs of abuse at Screening.
- •The participant was a pregnant or breast-feeding female, or was a female of child-bearing potential that was not using appropriate birth control.
- •The participant was unable to lie supine for 1 hour.
- •The participant had any thyroid disease other than adequately treated hypothyroidism.
- •The participant had known or suspected allergy/hypersensitivity to any ingredient in Altropane or to the thyroid blocking medication to be used before imaging.
- •The participant was taking any of the medications/treatments listed in the protocol as disallowed and could not or would not discontinue use at least 12 hours prior to SPECT exam.
- •The participant was referred to DaTscan imaging for evaluation of possible cognitive impairment including dementia.
研究组 & 干预措施
Altropane (123I) Injection
Experimental
干预措施: Altropane (123I) Injection (Drug)
结局指标
主要结局
Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers
时间窗: Day 1, up to 30 minutes
Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers).
次要结局
- Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization)(Day 1, up to 30 minutes)
- Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality)(Day 1, up to 30 minutes)
- Inter-Reader Agreement on Percentage of Participants With Normal Images(Day 1, up to 30 minutes)
- Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)(From administration of Altropane until 24 hours post dose)
- Percentage of Participants With Adverse Drug Reaction (ADR)(From administration of Altropane until 24 hours post dose)
- Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs(From administration of Altropane until 24 hours post dose)
- Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose(From administration of Altropane until 24 hours post dose)
- Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose(From administration of Altropane until 24 hours post dose)
- Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose(From administration of Altropane until 24 hours post dose)
研究者
研究点 (4)
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