NL-OMON52414已完成不适用
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 - Buccal Apomorphine (APORON) administration
Criceto0 个研究点目标入组 40 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
- 已完成
- 发起方
- 入组人数
- 40
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 99（—）
入选标准
- •Part A and B
- •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.
- •6) Mini-Mental State Examination (MMSE) score >= 20 and assessed by the
- •investigator or qualified designee as able to provide informed consent.
- •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
- •11) Subjects who experience motor fluctuations with recognizable OFF periods at
- •least once per day.
排除标准
- •Part A and B:
- •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.
- •As in part A, but with the following differences:
- •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 prior to first
- •dose, or history of long QT syndrome.
- •3) Contraindications to the excipients of the buccal or sublingual apomorphine
- •formulation, or contraindications to domperidone.
- •12) Elevated hepatic panel, defined as serum levels of ALT, AST, GGT, ALP or
- •TBL higher than 2 times the upper limit of normal.
- •19) Use of any apomorphine formulation in the 4 weeks prior to first dosing.
- •20) Use of 5HT3 antagonists.
- •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.
研究者
相似试验
进行中（未招募）
1 期
A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.Parkinson's DiseaseEUCTR2019-003315-60-NLCriceto IKM B.V.46
进行中（未招募）
1 期
Safety, pharmacokinetics and efficacy of Dupilumab in patients =6 months to <6 years with moderate-to-severe atopic dermatitisPart B: Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2016-000955-28-GBRegeneron Pharmaceuticals, Inc.200
进行中（未招募）
1 期
Safety, pharmacokinetics and efficacy of Dupilumab in patients =6 months to <6 years with moderate-to-severe atopic dermatitisPart B: Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2016-000955-28-PLRegeneron Pharmaceuticals, Inc.202
进行中（未招募）
1 期
Safety, pharmacokinetics and efficacy of Dupilumab in patients =6 months to <6 years with moderate-to-severe atopic dermatitisEUCTR2016-000955-28-DERegeneron Pharmaceuticals, Inc.202
招募中
不适用
Buccal Apomorphine (APORON) administratioParkinson's DiseaseNL-OMON26898Criceto46