EUCTR2015-005626-19-ES进行中（未招募）1 期
A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Civitas Therapeutics, a wholly owned subsidiary of Acorda0 个研究点目标入组 440 人开始时间: 2016年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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
- •Inclusion Criteria (not assessed for the CVT-301-004 study
- •? Has signed and dated an IRB/IEC-approved informed
- •consent form before any protocol-specific screening
- •procedures are performed.
- •? Is a male or female aged 30 to 86 years, inclusive. Women
- •of child-bearing potential must use protocol-defined
- •contraceptive measures and must have a
- •negative serum human chorionic gonadotropin (hCG) test at
- •screening. These patients must be willing to remain on their
- •current form of contraception for the duration of the study.
- •? Patients who have idiopathic PD (i.e., not induced by drugs
- •or other diseases) as defined by fulfilling Steps 1 and 2 of
- •the United Kingdom (UK) Brain Bank criteria, diagnosed
- •after the age of 30 years.
- •? Patients who are classified as Stage 1 to 3 (in the ON state)
- •on the modified Hoehn and Yahr scale for staging of PD
- •? Patients who have experienced motor fluctuations for a
- •minimum of 2 hours of average daily OFF time per waking
- •day (excluding early morning OFF time) by self-report and
- •confirmed by the PD Diary (on 3 consecutive days) during
- •the screening period.
- •? Patients who are on a LD-containing therapy, not including
- •Rytary (or equivalent), must be stable on oral LD-containing
- •therapy for at least 2 weeks prior to SV1 with a
- •LD/dopamine decarboxylase inhibitor (DDI)-containing
- •? Patients who are on a LD-containing therapy, when
- •including Rytary (or equivalent), should be on a stable dose
- •for at least 6 weeks prior to SV1
- •? The frequency of L-dopa administrations must be at least 3
- •times during the waking day and a total daily LD dose of ?
- •? Patients should be stable on other PD medications for at
- •least 4 weeks prior to SV1.
- •? Patients must have a ?25% difference between UPDRS Part
- •3 scores recorded in their ON and OFF states at screening.
- •? Patients must have normal cognition as confirmed by a score
- •of ?25 on the MMSE (in the ON state).
- •? Patients must be able to perform a spirometry maneuver in
- •the ON and OFF states and must have a screening FEV1 ?
- •50% of predicted, and an FEV1/FVC ratio > 60% in the ON
- •state at screening. (A pulmonologist will review the
- •spirometry tracings/morphology of any patients with an
- •FEV1 that is ? 50% to < 60% of predicted or an FEV1/FVC
- •ratio that is >60% to <70% in order to determine eligibility.
- •Patients with an FEV1/FVC ratio that is >60% to <70% will
- •complete spirometry before and after the administration of a
- •bronchodilator in a pulmonary function laboratory. Testing
- •will be performed in accordance with the 2005
- •ATS/European Respiratory Society [ERS] criteria prior to
- •randomization. The results of the bronchodilator challenge
- •will be reviewed by a pulmonologist prior to potential
- 另有 7 项未显示
排除标准
- •? Patients who have dyskinesia of a severity that would
- •significantly interfere with their ability to participate or
- •perform study procedures.
- •? Pregnant or lactating females or females wishing to become
- •? Patients who have any known contraindication to the use of
- •LD, including a history of malignant melanoma or a history
- •of narrow-angle glaucoma.
- •? Patients who have had previous surgery for PD (including
- •but not limited to cell transplantation) or plan to have
- •stereotactic surgery during the study period. Patients who
- •have had deep brain stimulation [DBS] will also be excluded
- •unless the procedure was performed more than 6 months
- •prior to study enrollment.
- •? Patients with a history of psychotic symptoms requiring
- •treatment, or suicidal ideation or attempt within the prior
- •? Patients who have cancer with the exception of the
- •following: basal cell carcinoma or successfully treated
- •squamous cell carcinoma of the skin; cervical carcinoma in
- •situ; prostatic carcinoma in situ; or other malignancies
- •curatively treated and with no evidence of disease recurrence
- •for at least 3 years.
- •? Patients taking certain prohibited medications.
- •? Patients with a history of drug or alcohol abuse within the
- •prior 12 months.
- •? Patients with chronic obstructive pulmonary disease
- •(COPD), asthma, or other chronic respiratory disease within
- •the last 5 years
- •? Patients with any contraindication to performing routine
- •spirometry or who are unable to perform a spirometry
- •? Patients with a current history of symptomatic orthostatic
- •hypotension despite adequate treatment.
- •? Patients with any condition that in the investigator?s opinion
- •would make patients unable to comply with study procedures or make them unsuitable for their participation in the study.
- •? Patients who have any clinically significant abnormality or
- •finding from examination, tests, or history that may
- •compromise patient safety. Potential issues of concern
- •should be raised to the medical monitor during eligibility
- •? For new CVT-301 naïve patients, patients who have been
- •treated with an investigational drug within 4 weeks or 5 halflives (whichever is longer) prior to the beginning of the
- •screening period (this includes investigational formulations
- •of marketed products).
研究者
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