EUCTR2017-002455-29-IT进行中（未招募）1 期
A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatmentof Agitation in Patients with Dementia of the Alzheimer's Type - Extension Study of AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of t
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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. Patient has successfully completed Studies 15-AVP-786 301, 15-AVP-786-302, 17-AVP-786-305, or 12-AVR-131
- •and is deemed eligible forenrollment by the investigator after review of theinclusion/exclusion criteria.
- •8. Patient has stable cardiac, pulmonary, hepatic, and renal function.
- •10. If female of childbearing potential, must have been practicing a medically-acceptable method of birth
- •control and continue with the same method during the entire study duration (oral contraceptive tablets,
- •hormonal implant device, hormone patch, intrauterine device, diaphragm and contraceptive cream or foam,
- •condom with spermicide, or abstinence) or be surgically sterile or post-menopausal.
- •15. Patients from Study 12-AVR-131 must not show current and significant symptoms of a depressive disorder
- •and must have a score <10 in the Cornell Scale for Depression in Dementia (CSDD) at Screening for. Patients rolling
- •over from Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305 with scores greater than 10 in the CSDD at
- •baseline should be evaluated by the investigator for enrollment in the current study.
- •17. Caregiver must be willing and able to comply with study procedures, including not administering any
- •prohibited medications during the course of the study.
- •18. Patient/caregiver must be willing to sign and receive a copy of patient/caregiver informed consentform (ICF) after
- •the nature and risks of study participation have been fully explained. Patients who are not capable of signing the ICF
- •but are able to provide assent, or the patient's authorized representative agrees to participation (for patients unable
- •to provide assent) are allowed.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •1. Patient is currently participating in, or has participated in other interventional (drug or device)
- •clinical study since exiting Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, or within 30 days prior to
- •baseline for patients from Study 12-AVR-131.
- •2. Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- •3. Patients with co-existent clinically significant or unstable systemic diseases that could confound
- •the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or
- •untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary,
- •renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular
- •heart disease). Certain other nonmetastatic cancer may be allowed. For patients from Study 12-AVR-131,
- •each case to be evaluated individually with the Medical Monitor (MM).
- •4. Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by
- •the investigator
- •6. Patients who are currently using or were on NUEDEXTA® in the 2 weeks preceding Baseline.
- •7. Patients with evidence of serious risk of suicide at Screening (patients from Study 12-AVR-131) and Baseline
- •based on the Sheehan Suicidality Tracking Scale (S-STS), i.e., a score of 3 or 4 on any one question 2 through 6 or 11
- •or a score of 2 or higher on any one questions 1a, 7 through 10, or 12, or who, in the opinion of the investigator,
- •present a serious risk of suicide.
研究者
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