EUCTR2017-002455-29-HU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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •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 consent form (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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