EUCTR2017-002455-29-IT
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Agitation Associated with Dementia of the Alzheimer's Type
- Sponsor
- AVANIR PHARMACEUTICALS, INC.
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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