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



Status:Recruiting
Conditions:Alzheimer Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:2/10/2019
Start Date:December 2015
End Date:June 2022
Contact:Fred Ledon
Email:fledon@avanir.com
Phone:949-389-6724

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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

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

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

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 700 participants will be enrolled at approximately 135 centers in North
America.

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

Inclusion Criteria:

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

- 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
We found this trial at
154
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1101 Bryan Avenue
Tustin, California 92780
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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8200 SW 117th Ave # 210
Miami, Florida 33183
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Amherst, New York 14226
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Atlanta, Georgia 30322
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Atlantis, Florida 33462
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Beaver, Pennsylvania 15009
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200 Springs Road
Bedford, Massachusetts 01730
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Bellevue, Ohio 44811
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357 Shields Drive
Bennington, Vermont 05201
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Boca Raton, Florida 33428
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Brandon, Florida 33511
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Brooklyn, New York 11214
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Brooklyn, New York 11229
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Centerville, Ohio 45459
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4045 West Chandler Boulevard
Chandler, Arizona 85226
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205 Westbury Drive
Chapel Hill, North Carolina 27517
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Charleston, South Carolina 29401
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109 Bee Street
Charleston, South Carolina 29401
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Charlotte, North Carolina 28211
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, Ohio 45227
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Clinton, Utah 84015
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Columbus, Georgia 31909
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Cordova, Tennessee 38018
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Creve Coeur, Missouri 63141
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Cromwell, Connecticut 06416
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, Texas 75214
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Danbury, Connecticut 06810
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Deerfield Beach, Florida 33064
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Doral, Florida 33166
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Providence, Rhode Island 02914
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Elk Grove Village, Illinois 60007
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1125 N College Avenue West Tower
Fayetteville, Arkansas 72703
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Franklin, Tennessee 37064
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Glendale, California 91204
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Hamden, Connecticut 06518
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1055 East 4th Avenue
Hialeah, Florida 33013
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, Indiana 46256
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Irvine, California 92697
949-824-5011
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Irvine, California 92618
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Jacksonville, Florida 32216
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Kissimmee, Florida 34759
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La Habra, California 90631
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Lake Worth, Florida 33449
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Las Vegas, Nevada 89144
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Mansfield, Texas 76063
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286 Westward Drive
Miami, Florida 33176
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Miami, Florida 33176
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1830 Northwest 7th Street
Miami, Florida 33125
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1801 Coral Way
Miami, Florida 33133
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10346 West Flagler Street
Miami, Florida 33144
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3659 South Miami Avenue
Miami, Florida 33145
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11005 Southwest 84th Street
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Mount Arlington, New Jersey 07856
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Naples, Florida 34102
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300 Tower Road
Naples, Florida 34102
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