EUCTR2015-005067-17-CZ进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 339
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. Has signed and dated an IRB/IEC-approved informed consent form before any protocol-specific screening procedures are performed.
- •2. Is a male or female aged 30 to 85 years, inclusive.Women of child-bearing potential must use protocol-defined contraceptive measures (see Section 11.1.5) 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.
- •3. 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.
- •4. Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
- •5. 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.
- •6a. 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/DDI-containing regimen
- •6b. 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.
- •6c. The frequency of L-dopa administrations must be at least 3 times during the waking day and a total daily LD dose of = 1600 mg.
- •7. Patients should be stable on other PD medications for at least 4 weeks prior to SV1.
- •8. Patients must have a = 25% difference between UPDRS Part 3 scores recorded in their ON and OFF states at screening.
- •9. Patients must understand (with or without caregiver assistance) their daily medication regimen and must agree that they will not change their daily medication doses during the study.
- •10. Patients must have normal cognition as confirmed by a score of = 25 on the Mini Mental State Examination (MMSE), performed in the ON state.
- •11. 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.
- •12. (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 randomization.)
- •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 248
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 97
排除标准
- •1. Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
- •2. Pregnant or lactating females or females wishing to become pregnant.
- •3. Patients who have any known contraindication to the use of LD, including a history of malignant melanoma or a history of narrow-angle glaucoma.
- •4. Patients who have had previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation) or plan to have stereotactic surgery during the study period.
- •5. Patients with a history of psychotic symptoms requiring treatment, or suicidal ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to SV1] of anti-depressant medications and certain low-dose atypical antipsychotic medications are permitted in case they are indicated to treat symptoms other than psychotic symptoms).
- •6. 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.
- •7. Patients taking certain prohibited medications (see Section 9.4.2).
- •8. Patients with a history of drug or alcohol abuse within the prior 12 months.
- •9. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years.
- •10. Patients with any contraindication to performing routine spirometry or who are unable to perform a spirometry maneuver (see Appendix 14 for a list of contraindications).
- •11. Patients with a current history of symptomatic orthostatic hypotension despite adequate treatment.
- •12. Patients with any condition that in the investigator’s opinion would make patients unable to comply with study procedures or make them unsuitable for participation in the study.
- •13. 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 review.
- •14. Patients who have participated in any prior CVT-301 study, regardless of treatment group assignment.
- •15. Patients who have been treated with an investigational drug within 4 weeks or 5 half-lives (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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