NL-OMON26898招募中不适用
A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease
Criceto0 个研究点目标入组 46 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male or female, 30-85 years of age, inclusive at screening.
- •4) Clinical diagnosis (confirmed by a neurologist) of Parkinson’s disease and classified by the investigator as Hoehn and Yahr stage I to IV in the ON state.
- •5) Having clear, self-described motor fluctuations as assessed by the 9-symptom Wearing-off Questionnaire (WOQ-9): at least one motor symptom (Question 1, 2, 4, 6, 9) indicated to improve after the subject’s next antiParkinson medication dose.
- •6) Mini-Mental State Examination (MMSE) score = 20 and assessed by the investigator or qualified designee as able to provide informed consent.
- •Part B and C
- •1) Male or female, 30-85 years of age, inclusive at screening.
- •4) Clinical diagnosis (confirmed by a neurologist) of Parkinson’s disease and classified by the investigator as Hoehn and Yahr stage I to III in the ON state.
- •5) Mini-Mental State Examination (MMSE) score = 20 and assessed by the investigator or qualified designee as able to provide informed consent.
- •8) On a stable dose of 1 to 4 mg subcutaneous apomorphine (APO-GO PEN) for the management of OFF episodes for at least 4 weeks prior to first study drug administration.
- •9) Subject’s at-home subcutaneous apomorphine injection location is the abdomen.
- •11) Subjects who experience motor fluctuations (as assessed by the 9-symptom Wearing-off Questionnaire (WOQ-9): at least one motor symptom (Question 1, 2, 4, 6, 9) indicated to improve after the subject’s next antiParkinson medication dose) with recognizable OFF periods at least once per day.
排除标准
- •1) Atypical or secondary parkinsonism e.g., multiple-system atrophy or progressive supranuclear palsy, or evidence of drug-induced parkinsonism.
- •2) Subjects with a borderline QT interval corrected for heart rate according to Fridericia's formula (QTcF) of >450 ms for male and >470 ms for female, PR interval > 220 msec or QRS duration > 120 msec at screening or history
- •of long QT syndrome.
- •6) Currently taking medication that can influence the efficacy of apomorphine in the opinion of the investigator, such as dopamine antagonists and dopamine depleting drugs, with the exception of domperidone.
- •Part B and C:
- •1) Atypical or secondary parkinsonism e.g., multiple-system atrophy or progressive supranuclear palsy, or evidence of drug-induced parkinsonism.
- •2) Subjects with a borderline QT interval corrected for heart rate according to Fridericia’s formula (QTcF) of >450 ms for male and >470 ms for female, PR interval > 220 msec or QRS duration > 120 msec at screening or history
- •of long QT syndrome.
- •4) Use of apomorphine formulations other than subcutaneous injections in the 4 weeks prior to first dosing.
- •7) Currently taking medication that can influence the efficacy of apomorphine in the opinion of the investigator, such as dopamine antagonists and dopamine depleting drugs, with the exception of domperidone.
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