EUCTR2016-003456-70-DE进行中（未招募）1 期
An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 106
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
- •1 The subject (and caregiver, if applicable) must be fully informed of and
- •understand the objectives, procedures, and possible benefits and risks of
- •the study, and give written informed consent prior to performing any
- •study-related activities.
- •2 Male or female = 18 years of age.
- •3 Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank
- •Criteria (excluding the more than one affected relative criterion).
- •4 Clinically meaningful response to levodopa (L-Dopa), as determined by
- •the Investigator.
- •5 Subjects at Screening must demonstrate an adequate L-Dopa response
- •on the MDS-UPDRS Part III in the ON state compared to the MDS
- •Part III in the OFF state and on the Hoehn and Yahr, as
- •determined during the review by Enrollment Adjudication Committee
- •(EAC), Sponsor, and Medical Monitor.
- •6 Receiving stable doses of L-Dopa/carbidopa and/or L-Dopa/
- •benserazide and/or L-Dopa/carbidopa/entacapone (immediate or
- •chronic release) administered at least 4 times per day OR RytaryTM
- •administered at least 3 times per day for at least 4 weeks before the
- •Initial Screening Visit (SV1). Adjunctive PD medication regimens are
- •permitted but must be maintained at a stable dose for at least 4 weeks
- •prior to SV1 with the exception of monoamine oxidase B (MAO-B)
- •inhibitors, which must be maintained at a stable level for at least 8
- •weeks prior to SV1. Use of Madopar PRN in the 4 weeks prior to screening
- •is permitted. Current use of a sc apomorphine by injection at the
- •time of screening is permitted.
- •7 No planned medication change(s) or surgical intervention anticipated
- •during the course of study.
- •8 Subjects must experience at least one well defined OFF episode per
- •day and have a total daily OFF time duration of > 2 hours during the
- •waking day, based on judgment of physician and subject self
- •assessment.
- •9 Subject must have predictable morning OFF periods, based on
- •judgment of physician and subject self-assessment.
- •10 Subject, and where appropriate caregiver, must be trained in
- •completing the home dosing diaries and able to recognize ON and
- •OFF states.
- •11 Stage III or less on the modified Hoehn and Yahr scale in the ON
- •12 Mini–Mental State Examination (MMSE) score > 25.
- •13 Female subject of childbearing potential and male subject with
- •female partner of childbearing potential must agree to either remain
- •abstinent or use adequate and reliable contraception (see Section 10.4.1
- •for additional information on acceptable methods of birth control)
- •throughout the study and for at least 7 days after the last dose of study
- •drug has been taken. Note: Continued use of adequate and reliable
- •contraception is recommended through 30 days after study completion.
- •14 Willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests, and other study-related procedures to complete the
- •15 Must be approved as a satisfactory candidate by the Enrollment
- •Adjudication Committee (EAC), Medical Monitor, and Sponsor.
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •1 Atypical or secondary parkinsonism.
- •2 Major focal brain disorders including malignancy or stroke.
- •3 Prior treatment with any of the following: a neurosurgical procedure
- •for PD; continuous subcutaneous (sc) apomorphine infusion; sc
- •apomorphine injection; Duodopa/Duopa; or APL-130277.
- •4. Subjects who have permanently stopped use of s.c. apomorphine
- •(injection).
- •5 Female who is pregnant or lactating.
- •6 Participation in an interventional clinical study and/or receipt of any
- •investigational (ie, unapproved) medication within 30 days prior to SV1.
- •7 Currently taking selective 5HT3 antagonists (ie, ondansetron,
- •granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists
- •(excluding quetiapine or clozapine) or dopamine depleting agents.
- •Subjects receiving anti-depressants must be on a stable daily dose for at
- •least 8 weeks prior to SV1.
- •8 current diagnosis or history of substance abuse (excluding nicotine
- •and caffeine) or alcohol abuse (in the opinion of the investigator) < 6
- •months prior to SV1.
- •9 positive urine drug screen result. NOTE: Benzodiazepines, opiates, and
- •oxycodone will be allowed provided the subject has been on a stable
- •dose for 4 weeks prior to SV1, provided the subject has a valid
- •prescription. Cotinine is not exclusionary.
- •10 The recreational use of cannabinoids and hallucinogenic(including
- •formulations of CBD) and hallucinogenics are excluded, as well any use
- •of a sublingual formulation of any drug.
- •11 history of malignancy within 5 years prior to SV1, except for
- •adequately treated basal cell or squamous cell skin cancer or in situ
- •cervical cancer.
- •12 clinically significant abnormality on screening evaluation including
- •physical examination, vital signs, electrocardiogram (ECG), or laboratory
- •tests that the Investigator considers to be inappropriate to allow
- •participation in the study.
- •13 screening laboratory test results of: BUN value = 1.5 times the upper
- •limit of normal (ULN) for the reference range; serum creatinine > 1.5
- •times the ULN for the reference range; or ALT or AST value = 2 times the
- •ULN for the reference laboratory.
- •14 random (non-fasting) screening glucose of = 200 mg/dL (11.1
- •mmol/L) or HbA1c > 7.0%.
- •15 Subjects with type 1 diabetes, or insulin-dependent diabetics are
- •excluded. Subjects with type 2 diabetes are eligible for study inclusion if
- •the following conditions are met:
- •Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note:
- •Subjects with random (non-fasting) blood glucose at screening = 200
- •mg/dL (11.1 mmol/L) must be retested in a fasted state; and
- •Subject's HbA1c = 7.0%; and
- •If the subject is currently being treated with oral anti-diabetic
- •medication(s), the dose must have been stable for at least 4 weeks prior
- •to SV1. Such medication may be adjusted or discontinued during the
- •study, as clinically indicated.
- •16 The subject's screening ECG results of corrected QT interval using
- 另有 9 项未显示
研究者
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