EUCTR2017-002455-29-HU
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Avanir Pharmaceuticals, Inc.
- Enrollment
- 1200
- Status
- Active, not recruiting
- Last Updated
- 4 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
- •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.
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
Outcomes
Primary Outcomes
Not specified
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