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Long Term, Extension Study of the Safety and Efficacy of AVP-786 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: NCT02446132
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

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

Detailed Description:

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1000 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study Start Date : December 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: AVP-786 (dose 1)
AVP-786 dose 1; capsules administered twice a day over a 52-week period
Drug: AVP-786
Experimental: AVP-786 (dose 2)
AVP-786 dose 2; capsules administered twice a day over a 52-week period
Drug: AVP-786
Experimental: AVP-786 (dose 3)
AVP-786 dose 3; capsules administered twice a day over a 52-week period
Drug: AVP-786



Primary Outcome Measures :
  1. Number of Participants with any Treatment-Emergent Adverse Event [ Time Frame: up to 64 weeks ]
  2. Number of Participants with any Treatment-Emergent Serious Adverse Event [ Time Frame: up to 64 weeks ]
  3. Number of Participants with any abnormal, clinically significant Clinical Laboratory Value [ Time Frame: up to 52 weeks ]
  4. Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value [ Time Frame: up to 52 weeks ]
  5. Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding [ Time Frame: up to 52 weeks ]
  6. Number of participants with any abnormal, clinically significant vital sign value [ Time Frame: up to 52 weeks ]
  7. Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score [ Time Frame: Baseline; Week 64 ]
  8. Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline; Week 52 ]
  9. Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline; Week 52 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 64 ]
  2. Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline; Week 52 ]
  3. Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score [ Time Frame: Baseline; Week 64 ]
  4. Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 52 ]
  5. Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 52 ]
    PGIC (rated by caregiver)

  6. Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 52 ]
  7. Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 52 ]
  8. Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305 [ Time Frame: Baseline; Week 52 ]

Other Outcome Measures:
  1. Number of participants using concomitant medications [ Time Frame: up to 64 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.
  • Participants from Study 12-AVR-131 with a diagnosis of probable AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
  • Either out-patients or residents of an assisted-living facility or a skilled nursing home
  • Participants from Study 12-AVR-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
  • Participants from Study 12-AVR-131 with a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Participants from Study 12-AVR-131 with a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
  • Participants from Study 12-AVR-131 with a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

  • 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 determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
  • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

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): NCT02446132


Contacts
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Contact: Fred Ledon 949-389-6724 fledon@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

  Hide Study Locations
Locations
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United States, Arizona
Brain and Spine Center Withdrawn
Chandler, Arizona, United States, 85226
Banner Alzheimer's Institute Withdrawn
Phoenix, Arizona, United States, 85006
NoesisPharma, LLC Completed
Phoenix, Arizona, United States, 85032
Perseverance Research Center, LLC Active, not recruiting
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Health Initiatives Research Active, not recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Behavioral Research Specialists, LLC Active, not recruiting
Glendale, California, United States, 91206
Irvine Center for Clinical Research Active, not recruiting
Irvine, California, United States, 92614
University of California, Irvine Withdrawn
Irvine, California, United States, 92697
Omega Clinical Trials, LLC Withdrawn
La Habra, California, United States, 90631
Collaborative Neuroscience Network, LLC. Completed
Long Beach, California, United States, 90806
Shankle Clinic Withdrawn
Newport Beach, California, United States, 92663
NRC Research Institute Active, not recruiting
Orange, California, United States, 92868
California Neurological Services Active, not recruiting
Panorama City, California, United States, 91402
Havana Research Institute Active, not recruiting
Pasadena, California, United States, 91105
Pacific Research Network, Inc. #1 Active, not recruiting
San Diego, California, United States, 92103
Pacific Research Network, Inc. #2 Active, not recruiting
San Diego, California, United States, 92103
VA San Diego Healthcare System Withdrawn
San Diego, California, United States, 92103
HB Clinical Trials Inc. Active, not recruiting
Santa Ana, California, United States, 92704
Syrentis Clinical Research Active, not recruiting
Santa Ana, California, United States, 92705
Viking Clinical Research Active, not recruiting
Temecula, California, United States, 92591
New Foundation Medical Group Clinical Trials Withdrawn
Tustin, California, United States, 92780
United States, Colorado
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies Completed
Denver, Colorado, United States, 80209
United States, Connecticut
Connecticut Clinical Research Withdrawn
Cromwell, Connecticut, United States, 06416
Associated Neurologists, PC Withdrawn
Danbury, Connecticut, United States, 06810
Geriatric and Adult Psychiatry LLC Withdrawn
Hamden, Connecticut, United States, 06518
Coastal Connecticut Research, LLC Completed
New London, Connecticut, United States, 06320
Research Center for Clinical Studies, Inc. Active, not recruiting
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research Institute Completed
Atlantis, Florida, United States, 33462
Neurology Offices of South Florida Withdrawn
Boca Raton, Florida, United States, 33428
Clinical Research Of Brandon, LLC Completed
Brandon, Florida, United States, 33511
Meridien Research Completed
Brooksville, Florida, United States, 34601
Quantum Laboratories, Inc. Active, not recruiting
Deerfield Beach, Florida, United States, 33064
Moonshine Research Center, Inc Active, not recruiting
Doral, Florida, United States, 33166
Science Connections, LLC Active, not recruiting
Doral, Florida, United States, 33166
University of Florida Withdrawn
Gainesville, Florida, United States, 32607
Finlay Medical Research Corp Active, not recruiting
Green Acres, Florida, United States, 33467
Direct Helpers Research Center Withdrawn
Hialeah, Florida, United States, 33012
Indago Research & Health Center, Inc. Active, not recruiting
Hialeah, Florida, United States, 33012
New Life Medical Research Center, Inc. Active, not recruiting
Hialeah, Florida, United States, 33012
Reliable Clinical Research,LLC Active, not recruiting
Hialeah, Florida, United States, 33012
Research in Miami, Inc Active, not recruiting
Hialeah, Florida, United States, 33013
The Research Center, Inc Active, not recruiting
Hialeah, Florida, United States, 33013
Berma Research Group Completed
Hialeah, Florida, United States, 33016
Galiz Research Active, not recruiting
Hialeah, Florida, United States, 33016
Maxblue Institute Completed
Hialeah, Florida, United States, 33018
Clinical Neuroscience Solutions, Inc. Completed
Jacksonville, Florida, United States, 32256
SIH Research, LLC Active, not recruiting
Kissimmee, Florida, United States, 34741
Alzheimer's Research and Treatment Center #1 Completed
Lake Worth, Florida, United States, 33449
Alzheimer's Research and Treatment Center #2 Active, not recruiting
Lake Worth, Florida, United States, 33449
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Premier Clinical Research Institute, Inc. #1 Active, not recruiting
Miami, Florida, United States, 33122
Premier Clinical Research Institute, Inc. #2 Completed
Miami, Florida, United States, 33122
Global Medical Institutes, LLC Active, not recruiting
Miami, Florida, United States, 33125
Project 4 Research #1 Completed
Miami, Florida, United States, 33125
Project 4 Research #2 Active, not recruiting
Miami, Florida, United States, 33125
BioMed Research Institute Active, not recruiting
Miami, Florida, United States, 33126
Finlay Medical Research Corp Recruiting
Miami, Florida, United States, 33126
CCM Clinical Research Group Active, not recruiting
Miami, Florida, United States, 33133
Innova Clinical Trials Completed
Miami, Florida, United States, 33133
Advance Medical Research Center #1 Completed
Miami, Florida, United States, 33135
Advance Medical Research Center #2 Active, not recruiting
Miami, Florida, United States, 33135
Dade Research Center Llc Active, not recruiting
Miami, Florida, United States, 33135
Vitae Researrch Center LLC Active, not recruiting
Miami, Florida, United States, 33135
University of Miami Completed
Miami, Florida, United States, 33136
Miami Jewish Health Systems, Inc. Active, not recruiting
Miami, Florida, United States, 33137
AMB Research Center, Inc. Withdrawn
Miami, Florida, United States, 33144
United Health Research Corp. #1 Active, not recruiting
Miami, Florida, United States, 33144
United Health Research Corp. #2 Active, not recruiting
Miami, Florida, United States, 33144
Advanced Medical Center Group Terminated
Miami, Florida, United States, 33145
Future Care Solution, LLC Active, not recruiting
Miami, Florida, United States, 33165
Clinical Research Associates of South Florida #1 Active, not recruiting
Miami, Florida, United States, 33172
Clinical Research Associates of South Florida #2 Recruiting
Miami, Florida, United States, 33172
Coral Research Clinic Corp Active, not recruiting
Miami, Florida, United States, 33175
P&S Research, Llc. Active, not recruiting
Miami, Florida, United States, 33175
Miami Dade Medical Research Institute, LLC Withdrawn
Miami, Florida, United States, 33176
The Neurology Research Group, LLC Withdrawn
Miami, Florida, United States, 33176
International Research Associates, LLC Withdrawn
Miami, Florida, United States, 33183
Kendall Research Institute Completed
Miami, Florida, United States, 33183
Nuovida Research Center Corp. Active, not recruiting
Miami, Florida, United States, 33186
Research Institute of West Kendall Recruiting
Miami, Florida, United States, 33186
Collier Neurologic Specialists, LLC Active, not recruiting
Naples, Florida, United States, 34102
Naples Research, Inc Terminated
Naples, Florida, United States, 34102
Bayside Clinical Research Recruiting
New Port Richey, Florida, United States, 34655
Lazlo J. Mate, MD, PA Withdrawn
North Palm Beach, Florida, United States, 33408
Research Centers of America, LLC Completed
Oakland Park, Florida, United States, 33334
Sensible Healthcare Withdrawn
Ocoee, Florida, United States, 34761
Compass Research, LLC Completed
Orlando, Florida, United States, 32806
Neurology Associates of Ormond Beach Completed
Ormond Beach, Florida, United States, 32174
Innovation Medical Research Center Active, not recruiting
Palmetto Bay, Florida, United States, 03157
IMIC Inc. Completed
Palmetto Bay, Florida, United States, 33157
University of West Florida Active, not recruiting
Pensacola, Florida, United States, 32514
Suncoast Neuroscience Associates, Inc. Withdrawn
Saint Petersburg, Florida, United States, 33713
Roskamp Institute Completed
Sarasota, Florida, United States, 34243
Olympian Clinical Research Active, not recruiting
Tampa, Florida, United States, 33609
University of South Florida Withdrawn
Tampa, Florida, United States, 33613
Compass Research North, LLC Completed
The Villages, Florida, United States, 32162
Neurology Research Institute Palm Beach, LLC #1 Completed
West Palm Beach, Florida, United States, 33407
Neurology Research Institute Palm Beach, LLC #2 Active, not recruiting
West Palm Beach, Florida, United States, 33407
Florida Premier Research Institute Completed
Winter Park, Florida, United States, 32789
United States, Georgia
Emory Brain Health Center Withdrawn
Atlanta, Georgia, United States, 30329
NeuroTrials Research Inc Completed
Atlanta, Georgia, United States, 30342
Columbus Research & Wellness Institute, INC Completed
Columbus, Georgia, United States, 31904
Medical Research & Health Education Foundation, Inc. Active, not recruiting
Columbus, Georgia, United States, 31909
United States, Illinois
Alexian Brothers Neurosciences Institute Withdrawn
Elk Grove Village, Illinois, United States, 60007
Behavioral Health Care Associates Withdrawn
Schaumburg, Illinois, United States, 60194
United States, Indiana
Indiana University School of Medicine Completed
Indianapolis, Indiana, United States, 46202
Josephson Wallack Munshower Neurology, PC Active, not recruiting
Indianapolis, Indiana, United States, 46256
United States, Kansas
MidAmerica Neuroscience Research Foundation Completed
Lenexa, Kansas, United States, 66214
United States, Kentucky
Four Rivers Clinical Research Inc. Completed
Paducah, Kentucky, United States, 42003
United States, Louisiana
J. Gary Booker, MD, APMC Withdrawn
Shreveport, Louisiana, United States, 71104
United States, Maryland
The Samuel & Alexia Bratton Memory Clinic Completed
Easton, Maryland, United States, 21601
Mir Neurology Completed
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Bedford VA Hospital Withdrawn
Bedford, Massachusetts, United States, 01730
Boston Center for Memory Active, not recruiting
Newton, Massachusetts, United States, 02459
Alzheimer's Disease Center Completed
Quincy, Massachusetts, United States, 02169
United States, Michigan
Onyx Clinical Research, LLC Recruiting
Caro, Michigan, United States, 48723
Michigan State University Department of Neurology Completed
East Lansing, Michigan, United States, 48824
Bronson Neurobehavioral Health Withdrawn
Paw Paw, Michigan, United States, 49079
United States, Missouri
Galen Research Recruiting
Chesterfield, Missouri, United States, 63005
Millennium Psychiatric Associates, LLC Completed
Creve Coeur, Missouri, United States, 63141
Saint Luke's Hospital of Kansas City Withdrawn
Kansas City, Missouri, United States, 64111
PsychCare Consultants Research Withdrawn
Saint Louis, Missouri, United States, 63128
Clinical Research Professionals Withdrawn
Saint Louis, Missouri, United States, 63141
United States, Nevada
Geriatric Solutions, LLC Withdrawn
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Flora Baker Center for Alzheimer's Disease and Related Disorders Withdrawn
Marmora, New Jersey, United States, 08223
The NeuroCognitive Institute Completed
Mount Arlington, New Jersey, United States, 07856
Bio Behavioral Health Active, not recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Dent Neurologic Institute Completed
Amherst, New York, United States, 14226
Brooklyn Medical Institute Withdrawn
Brooklyn, New York, United States, 11214
Integrative Clinical Trials LLC #1 Active, not recruiting
Brooklyn, New York, United States, 11229
Integrative Clinical Trials LLC #2 Active, not recruiting
Brooklyn, New York, United States, 11229
Columbia University Medical Center Completed
New York, New York, United States, 10032
Manhattan Behavioral Medicine, PLLC Completed
New York, New York, United States, 10036
Eastside Comprehensive Medical Center, LLC Completed
New York, New York, United States, 10128
Nathan S. Kline Institute for Psychiatric Research Completed
Orangeburg, New York, United States, 10962
University of Rochester Medical Center Completed
Rochester, New York, United States, 14620
Psychiatry and Alzheimer's Care of Rochester, PLLC Withdrawn
Rochester, New York, United States, 14623
Richmond Behavioral Associates Completed
Staten Island, New York, United States, 10312
Burke Rehabilitation Hospital Completed
White Plains, New York, United States, 10605
United States, North Carolina
Herbert Harris, Md, Phd, Pa Completed
Chapel Hill, North Carolina, United States, 27517
ANI Neurology PLLC dba Alzheimer's Memory Center Completed
Charlotte, North Carolina, United States, 28270
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Daystar Clinical Research Inc Withdrawn
Akron, Ohio, United States, 44313
Neurology and Neuroscience Associates, Inc. Completed
Akron, Ohio, United States, 44320
Insight Neuroscience, LLC Withdrawn
Bellevue, Ohio, United States, 44811
Valley Medical Research Completed
Centerville, Ohio, United States, 45459
CTI Clinical Research Center Withdrawn
Cincinnati, Ohio, United States, 45212
University of Cincinnati Completed
Cincinnati, Ohio, United States, 45219
The Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital Active, not recruiting
Lakewood, Ohio, United States, 44107
United States, Oklahoma
IPS Research Company Completed
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Clinical Research Center Completed
Oklahoma City, Oklahoma, United States, 73112
Tulsa Clinical Research, LLC Withdrawn
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Heritage Valley Medical Group, Inc. Active, not recruiting
Beaver, Pennsylvania, United States, 15009
The Birches at Newton / Family Medical Associates Withdrawn
Levittown, Pennsylvania, United States, 19056
Drexel University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Abington Neurological Associates, LTD Completed
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Mood & Memory Research Institute Completed
East Providence, Rhode Island, United States, 02914
United States, South Carolina
RH Johnson VA Medical Center Active, not recruiting
Charleston, South Carolina, United States, 29401
Roper St. Francis Healthcare Active, not recruiting
Charleston, South Carolina, United States, 29401
Coastal Neurology, PA Withdrawn
Port Royal, South Carolina, United States, 29935
BG Neurology Completed
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Neurology Clinic, P.C. Withdrawn
Cordova, Tennessee, United States, 38018
Clinical Research Solutions Withdrawn
Franklin, Tennessee, United States, 37064
United States, Texas
Texas Neurology, P.A. Completed
Dallas, Texas, United States, 75214
Neurology Consultants of Dallas, PA Completed
Dallas, Texas, United States, 75231
University Texas Southwestern Medical Center Completed
Dallas, Texas, United States, 75390-8898
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Houston Methodist Neurological Institute Completed
Houston, Texas, United States, 77030
University Hills Clinical Research Withdrawn
Irving, Texas, United States, 75062
Neurology Associates of Arlington Withdrawn
Mansfield, Texas, United States, 76063
Texas Medical Research Associates, L.L.C. Completed
San Antonio, Texas, United States, 78238
United States, Utah
Ericksen Research and Development Completed
Clinton, Utah, United States, 84015
Pharmaceuticals Research Associates, Inc. Completed
Salt Lake City, Utah, United States, 84107
United States, Vermont
Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic Completed
Bennington, Vermont, United States, 05201
Neuropsychiatric Associates Completed
Woodstock, Vermont, United States, 05091
United States, Virginia
Sentara Neurosciences Institute Withdrawn
Norfolk, Virginia, United States, 23510
Veteran Affairs Medical Center, Salem Virginia Completed
Salem, Virginia, United States, 24153
United States, Washington
Frontier Institute Withdrawn
Spokane, Washington, United States, 99204
United States, Wisconsin
IPC Research Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Bulgaria
Center for Mental Health - Ruse Recruiting
Ruse, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska Recruiting
Sofia, Bulgaria
Medica Plus Medical Center Recruiting
Veliko Tarnovo, Bulgaria
Canada
Dr. Alexander McIntyre Inc. Completed
Penticton, Canada
Czechia
Fakultni Nemocnice u sv. Anny v Brne Recruiting
Brno, Czechia
Námestí národního odboje 692 Recruiting
Kutna Hora, Czechia
AD71 Recruiting
Praha, Czechia
Clintrial Recruiting
Praha, Czechia
Neurologicka Ambulance - Forbeli Recruiting
Praha, Czechia
Neuropsychiatrie Recruiting
Praha, Czechia
Vestra Clinics Recruiting
Rychnov nad Kněžnou, Czechia
France
Centre Hospitalier Universitaire Dijon Bourgogn Recruiting
Dijon Cedex, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Recruiting
Toulouse, France
Hungary
Dr. Kenessey Albert Kórház-Rendelőintézet Recruiting
Balassagyarmat, Hungary
Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Recruiting
Budapest, Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz Recruiting
Debrecen, Hungary
PsychoTech Recruiting
Pécs, Hungary
Italy
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico Recruiting
Roma, Italy
Poland
Ksiedza Hugona Kollataja 9 Recruiting
Bydgoszcz, Poland
Care Clinic Recruiting
Katowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis Recruiting
Katowice, Poland
Krakowska Akademia Neurologii Recruiting
Kraków, Poland
Malopolskie Centrum Medyczne Recruiting
Kraków, Poland
Solumed Centrum Medyczne Recruiting
Poznań, Poland
Centrum Medyczne Euromedis Recruiting
Szczecin, Poland
Centrum Medyczne NeuroProtect Recruiting
Warszawa, Poland
South Africa
ACF Neurological Services Recruiting
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
Spain
Fundació ACE Recruiting
Barcelona, Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha Recruiting
Zamora, Spain
Hospital Viamed Montecanal Recruiting
Zaragoza, Spain
Sponsors and Collaborators
Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02446132     History of Changes
Other Study ID Numbers: 15-AVP-786-303
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
Signs and Symptoms