NL-OMON52046尚未招募3 期
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer*s type. - Otsuka 307
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •1. Males and females 50 to 90 years of age (inclusive) at the time of informed
- •2. Diagnosis of probable Alzheimer*s disease according to the 2011 NIA-AA
- •working groups criteria. Either outpatients or residents of an assisted living
- •facility, a skilled nursing home, a dementia unit, or any other type of
- •facility providing long-term care.
- •3. MMSE score between 8 and 24 (inclusive) at Screening and Baseline.
- •4. Patient has clinically significant, moderate-to-severe agitation for at
- •least 2 weeks prior to Screening that interferes with daily routine per the
- •Investigator*s judgment.
- •5. Patients who require pharmacotherapy for the treatment of agitation per the
- •Investigator*s judgment, after:
- •* An evaluation of reversible factors (eg, pain, infection, or polypharmacy),
- •* A course of nonpharmacological interventions (eg, redirecting behavior, group
- •activities, music therapy).
- •6. Diagnosis of agitation must meet the International Psychogeriatric
- •Association (IPA) provisional definition of agitation.
- •7. NPI-AA total score (frequency × severity) must be >= 4 at Screening and
- •8. Patient must meet an additional predetermined blinded eligibility criterion.
- •9. Patient has stable cardiac, pulmonary, hepatic, and renal function per the
- •Investigator*s judgment.
- •10. No clinically significant findings on the Screening ECGs based on central
- •review and on the Baseline predose ECG based on the machine read and
- •Investigator*s evaluation.
- •11. Women who are of childbearing potential and are sexually active must use an
- •effective method of birth control for at least 1 month prior to the Baseline,
- •during participation in the study, and for at least 30 days after the last dose
- •of study drug. The following requirements must be met:
- •* Women who are of childbearing potential must use 2 of the following
- •precautions in order to minimize the risk of failure of 1 method of birth
- •control: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device,
- •birth control pills, birth control depot injection, birth control implant, or
- •condom with spermicide or sponge with spermicide. Periodic abstinence (eg,
- •calendar, ovulation, symptothermal, post-ovulation methods), declaration of
- •abstinence for the duration of exposure to study drug, or withdrawal are not
- •acceptable methods of contraception.
- •* Women who are sterile (ie, had an oophorectomy and/or hysterectomy),
- •postmenopausal (defined as 12 consecutive months with no menses without an
- •alternative medical cause), or practice true abstinence (when this method is in
- •line with the preferred and usual lifestyle of the patient) are exempt from
- •this requirement.
- •* Women who are lactating, pregnant, or plan to become pregnant are not
- •eligible for participation in the study.
- •12. For restricted and prohibited concomitant medications, patients willing and
- •able to meet all protocol requirements for duration of stability or washout
- •prior to study entry and during the study (see protocol Table 3 Restricted and
- •Prohibited Concomitant Medications and Appendix 1 Prohibited Concomitant
- •Medications).
- •13. Caregiver must be willing and able to comply with all study procedures,
- •including adherence to administering study drug and not administering any
- •prohibited medications during the study. The caregiver must spend a minimum of
排除标准
- •1. Caregiver is unwilling or unable, in the opinion of the Investigator, to
- •comply with study instructions. 2. Patient has dementia predominantly of
- •non-Alzheimer*s type (eg, vascular dementia, frontotemporal dementia,
- •Parkinson*s disease, substance-induced dementia). 3. Patients with symptoms of
- •agitation that are not secondary to Alzheimer*s dementia (eg, secondary to
- •pain, other psychiatric disorder, or delirium). 4. Patients who have been
- •diagnosed with an Axis 1 disorder (Diagnostic and Statistical Manual of Mental
- •Disorders, 5th Edition, Text Revision [DSM-5] criteria) including, but not
- •limited to: * Schizophrenia, schizoaffective disorder, or other psychotic
- •disorders not related to dementia * Bipolar I or II disorder, bipolar disorder
- •not otherwise specified * Current Major Depressive Episode: Patients with a
- •history of major depressive disorder, that is currently not symptomatic, are
- •eligible. Patients currently on a stable dose(s) of allowed antidepressant
- •medication(s) for at least 3 months prior to the Screening visit are eligible.
- •5. Patients with myasthenia gravis (contraindication for quinidine). 6.
- •Patients with any personal history of complete heart block, QTc prolongation,
- •or torsades de pointes. a. Screening and Baseline predose QT interval corrected
- •for heart rate using the Fridericia*s formula (QTcF) of > 450 msec for males
- •and > 470 msec for females unless due to ventricular pacing (See Section
- •8.1.5). Screening ECGs will be based on central review. Baseline predose ECG
- •will be based on the machine read and Investigator*s evaluation; if the QTcF
- •result from the machine read is exclusionary, do not administer study drug and
- •please contact a Medical Monitor. b. Presence of premature ventricular
- •contractions (PVCs) as evaluated by a central reader and deemed clinically
- •significant by the Investigator. 7. Patients with any family history of
- •congenital QT interval prolongation syndrome. 8. Patients with known
- •hypersensitivity to DM, Q, opiate drugs (codeine, etc), or any other ingredient
- •of the study drug. 9. Patients who have ever received DM co-administered with Q
- •or d6-DM co-administered with Q. 10. Patients who would be likely to require a
- •prohibited concomitant medication during the study (see Table 3, Restricted and
- •Prohibited Concomitant Medications and Appendix 1 Prohibited Concomitant
- •Medications). 11. Patients with co-existent clinically significant or unstable
- •systemic diseases that could confound the interpretation of the safety results
- •of the study (eg, malignancy [except skin basal cell carcinoma], 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. Each case is to be evaluated individually with a Medical Monitor. 12.
- •Patients who are currently participating in or who have participated in other
- •interventional (drug or device) clinical study, or found to be a *Virtually
- •Certain* match in Clinical Trial Subject Database (CTSdatabase) with a patient
- •who has participated in another interventional drug or device study within 30
- •days of Baseline. 13. Patients with history of postural syncope or any history
- •of unexplained syncope (evaluated on
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