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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393520
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Agitation in Patients With Dementia of the Alzheimer's Type Drug: Placebo Drug: AVP-786 Phase 3

Detailed Description:

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.

Approximately 550 participants will be enrolled at approximately 90 centers worldwide.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design 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
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Drug: Placebo
oral capsules

Experimental: AVP-786; Dose 1
Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Drug: AVP-786
oral capsules

Experimental: AVP-786; Dose 2
Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
Drug: AVP-786
oral capsules




Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
  • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
  • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
  • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participants with myasthenia gravis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393520


Contacts
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Contact: Fred Ledon +1 949 389-6724 FLedon@avanir.com
Contact: Caroline Mason +44 (00) 7551 125 782 CMason@Otsuka-Europe.com

Locations
Hide Hide 134 study locations
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United States, Arizona
Liv Generations of Agritopia / CCT Recruiting
Gilbert, Arizona, United States, 85296
Liv Generations of Ahwatukee / CCT Terminated
Phoenix, Arizona, United States, 85048
Perseverance Research Center Recruiting
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Clinical Trials Inc. Terminated
Little Rock, Arkansas, United States, 72205
United States, California
Paradigm Clinical Research Centers, Inc. Terminated
La Mesa, California, United States, 91942
Havana Research Institute Recruiting
Pasadena, California, United States, 91105
United States, Florida
SFM Clinical Research, LLC Recruiting
Boca Raton, Florida, United States, 33487
Helix Biomedics LLC Terminated
Boynton Beach, Florida, United States, 33436
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Meridien Research - Lakeland Site Recruiting
Lakeland, Florida, United States, 33805
Zynak Clinical Services Terminated
Lauderdale Lakes, Florida, United States, 33313
Crystal Biomedical Research, LLC Recruiting
Miami Lakes, Florida, United States, 33014
City Medical Group RC Terminated
Miami, Florida, United States, 33126
Finlay Medical Research Corp Recruiting
Miami, Florida, United States, 33126
Miami Jewish Health Systems, Inc. Recruiting
Miami, Florida, United States, 33137
Clinical Research Associates of South Florida Terminated
Miami, Florida, United States, 33172
Pharmax Research of South Florida Recruiting
Miami, Florida, United States, 33175
Research Institute of West Kendall Terminated
Miami, Florida, United States, 33186
Bayside Clinical Research Recruiting
New Port Richey, Florida, United States, 34655
Academic Alliance in Dermatology Terminated
Tampa, Florida, United States, 33617
United States, Georgia
NeuroStudies. Net, LLC Terminated
Decatur, Georgia, United States, 30033
United States, Michigan
Onyx Clinical Research, LLC Terminated
Caro, Michigan, United States, 48723
United States, Missouri
Galen Research Recruiting
Chesterfield, Missouri, United States, 63005
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Nathan S. Kline Institute for Psychiatric Research Recruiting
Orangeburg, New York, United States, 10962
United States, Ohio
Insight Clinical Trials LLC Recruiting
Beachwood, Ohio, United States, 44122
Valley Medical Research Recruiting
Centerville, Ohio, United States, 45459
Onyx Clinical Research, LLC Recruiting
Youngstown, Ohio, United States, 44505
United States, Oklahoma
Newton Clinical Research Active, not recruiting
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
Keystone Clinical Studies, LLC Terminated
Norristown, Pennsylvania, United States, 19403
United States, Texas
InSite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
United States, Wisconsin
IPC Research Recruiting
Waukesha, Wisconsin, United States, 53188
Australia
Australian Alzheimer's Research Foundation Terminated
Nedlands, Australia
Neuro Trials Victoria Pty Ltd Terminated
Noble Park, Australia
The Alfred Hospital Terminated
Parkville, Australia
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski Recruiting
Pleven, Bulgaria
Medical Center Hipokrat-N EOOD Recruiting
Plovdiv, Bulgaria
Center for Mental Health - Ruse Recruiting
Ruse, Bulgaria
First Multiprofile Hospital for Active Treatment Sofia Recruiting
Sofia, Bulgaria
Medical Center Stimul Terminated
Sofia, Bulgaria
Medical Center Sveti Naum Recruiting
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska Recruiting
Sofia, Bulgaria
Medica Plus Medical Center Recruiting
Veliko Tarnovo, Bulgaria
Czechia
Fakultni Nemocnice u sv. Anny v Brne Recruiting
Brno, Czechia
Clinline Services s.r.0 Psychiatricka Ambulance Recruiting
Hostivice, Czechia
Fakultní Nemocnice Hradec Králové Recruiting
Hradec Kralové, Czechia
NeuropsychiatrieHK Recruiting
Hradec Králové, Czechia
Brain-Soultherapy Recruiting
Kladno, Czechia
Supervize Recruiting
Kutná Hora, Czechia
A-Shine s.r.o. Recruiting
Plzen, Czechia
AD71 Recruiting
Praha, Czechia
Clintrial Recruiting
Praha, Czechia
INEP Medical s.r.o. Institut Neuropsychiatricke Pece Recruiting
Praha, Czechia
Neurologicka Ambulance - Forbeli Recruiting
Praha, Czechia
Neuropsychiatrie Recruiting
Praha, Czechia
Vestra Clinics Recruiting
Rychnov nad Kněžnou, Czechia
France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre Terminated
Caen cedex 9, France
Centre Hospitalier de Calais Terminated
Calais, France
Centre Hospitalier Universitaire Dijon Bourgogn Recruiting
Dijon Cedex, France
Centre Hospitalier Universitaire de Poitiers Terminated
Poitiers, France
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Recruiting
Saint-Etienne, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Recruiting
Toulouse, France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois Terminated
Vandoeuvre les Nancy, France
Hungary
Dr. Kenessey Albert Kórház-Rendelőintézet Active, not recruiting
Balassagyarmat, Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Recruiting
Budapest, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz Recruiting
Debrecen, Hungary
Valeomed Egeszsegugyi es Szolgaltato Kft Terminated
Esztergom, Hungary
CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság Terminated
Miskolc, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Terminated
Nyiregyhaza, Hungary
PsychoTech Recruiting
Pecs, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Terminated
Szeged, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház Active, not recruiting
Székesfehérvár, Hungary
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Active, not recruiting
Brescia, Italy
Centro San Giovanni di Dio - Fatebenefratelli Terminated
Brescia, Italy
Università degli studi G.D'Annunzio Chieti Pescara Terminated
Chieti, Italy
Azienda Ospedaliero - Universitaria Careggi Recruiting
Firenze, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Terminated
Milano, Italy
Azienda Ospedaliera San Gerardo di Monza Terminated
Monza, Italy
Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi Recruiting
Ponderano, Italy
Azienda Ospedaliera Sant'Andrea Recruiting
Roma, Italy
Fondazione Policlinico Tor Vergata Recruiting
Roma, Italy
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico Recruiting
Roma, Italy
Poland
Śródmieście Przychodnia - Bydgoszcz Recruiting
Bydgoszcz, Poland
Centrum Medyczne Sensemed Terminated
Chorzów, Poland
Care Clinic Recruiting
Katowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis Recruiting
Katowice, Poland
Krakowska Akademia Neurologii Recruiting
Kraków, Poland
Pratia MCM Kraków Recruiting
Kraków, Poland
Medycyna Milorzab Recruiting
Lodz, Poland
Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej Terminated
Plewiska, Poland
Centrum Medyczne HCP Terminated
Poznań, Poland
Solumed Centrum Medyczne Recruiting
Poznań, Poland
Centrum Medyczne Euromedis Terminated
Szczecin, Poland
Centrum Medyczne NeuroProtect Recruiting
Warszawa, Poland
Centrum Medyczne Pratia Warszawa Terminated
Warszawa, Poland
South Africa
ACF Neurological Services Terminated
Cape Town, South Africa
Cape Trial Centre Recruiting
Cape Town, South Africa
Flexivest Fourteen Research Centre Recruiting
Cape Town, South Africa
Apollo Clinical Research Recruiting
Johannesburg, South Africa
Medical and Dental Centre Recruiting
Rosebank, South Africa
Dr. Chisto Carel Coetzee Terminated
Umhlanga, South Africa
Spain
Fundació ACE Terminated
Barcelona, Spain
Fundació Hospital de la Santa Creu i Sant Pau Terminated
Barcelona, Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Hospital Universitari Vall d'Hebrón Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain
Hospital General Universitario de Elche Recruiting
Elche, Spain
Hospital Universitari de Santa Maria Terminated
Lleida, Spain
Hospital General Universitario Gregorio Marañón Terminated
Madrid, Spain
Hospital Universitario 12 de Octubre Terminated
Madrid, Spain
Hospital Universitario La Paz Terminated
Madrid, Spain
Clínica Universidad de Navarra Recruiting
Pamplona, Spain
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla Terminated
Santander, Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain
Hospital Universitario y Politécnico de La Fe Terminated
Valencia, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha Recruiting
Zamora, Spain
Hospital Viamed Montecanal Recruiting
Zaragoza, Spain
United Kingdom
MAC Clinical Research - Barnsley Recruiting
Barnsley, United Kingdom
Research Institute for the Care of Older People Terminated
Bath, United Kingdom
Belfast Health and Social Care Trust Terminated
Belfast, United Kingdom
MAC Clinical Research - Blackpool Terminated
Blackpool, United Kingdom
MAC Clinical Research - Cannock Recruiting
Cannock, United Kingdom
MAC Clinical Research - Leeds Terminated
Leeds, United Kingdom
Re:Cognition Health - London Active, not recruiting
London, United Kingdom
South London and Maudsley NHS Foundation Trust Recruiting
London, United Kingdom
MAC Clinical Research - Manchester Terminated
Manchester, United Kingdom
Northamptonshire Healthcare NHS Foundation Trust Active, not recruiting
Northampton, United Kingdom
MAC Clinical Research - Liverpool Terminated
Prescot, United Kingdom
Southern Health NHS Foundation Trust Recruiting
Southampton, United Kingdom
Avon and Wiltshire Mental Health Partnership NHS Trust Terminated
Swindon, United Kingdom
North West Boroughs Healthcare NHS Foundation Trust Active, not recruiting
Warrington, United Kingdom
Sponsors and Collaborators
Avanir Pharmaceuticals
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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03393520    
Other Study ID Numbers: 17-AVP-786-305
2017-001339-38 ( EudraCT Number )
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avanir Pharmaceuticals:
Agitation
Dementia of the Alzheimer's type
Alzheimer's disease
AVP-786
Deudextromethorphan hydrobromide
Quinidine sulfate
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations