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Assessment of 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

NCT03393520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2024-11-20

No results posted yet for this study

Summary

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

Conditions

  • Agitation in Patients With Dementia of the Alzheimer's Type

Interventions

DRUG

Placebo

oral capsules

DRUG

AVP-786

oral capsules

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2023-11-17
Completion
2023-12-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • France
  • Hungary
  • Italy
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393520 on ClinicalTrials.gov