EUCTR2016-003456-70-GB进行中（未招募）1 期
An Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations
适应症
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 MDSUPDRS 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 LDopa/
- •benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytary™ 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.
- •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
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
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 Contraindications to domperidone, subcutaneous apomorphine, or
- •hypersensitivity to apomorphine hydrochloride or any of the ingredients
- •of subcutaneous apomorphine (notably sodium metabisulfite).
- •6 Female who is pregnant or lactating.
- •7 Participation in an interventional clinical study and/or receipt of any
- •investigational (ie, unapproved) medication within 30 days prior to SV1.
- •8 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.
- •9 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.
- •10 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.
- •11 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.
- •12 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.
- •13 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.
- •14 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.
- •15 random (non-fasting) screening glucose of = 200 mg/dL (11.1
- •mmol/L) or HbA1c > 7.0%.
- •16 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
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研究者
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