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

Use our guide to learn which trials are right for you!

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
sites
Waukesha, Wisconsin 53188
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
8200 SW 117th Ave # 210
Miami, Florida 33183
?
mi
from
Miami, FL
Click here to add this to my saved trials
342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
?
mi
from
New London, CT
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
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...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
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...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
Amherst, New York 14226
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlantis, Florida 33462
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
200 Springs Road
Bedford, Massachusetts 01730
?
mi
from
Bedford, MA
Click here to add this to my saved trials
Bellevue, Ohio 44811
?
mi
from
Bellevue, OH
Click here to add this to my saved trials
357 Shields Drive
Bennington, Vermont 05201
?
mi
from
Bennington, VT
Click here to add this to my saved trials
Boca Raton, Florida 33428
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Brooklyn, New York 11214
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooklyn, New York 11229
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Centerville, Ohio 45459
?
mi
from
Centerville, OH
Click here to add this to my saved trials
4045 West Chandler Boulevard
Chandler, Arizona 85226
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
205 Westbury Drive
Chapel Hill, North Carolina 27517
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29401
?
mi
from
Charleston, SC
Click here to add this to my saved trials
109 Bee Street
Charleston, South Carolina 29401
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45227
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Columbus, Georgia 31909
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cordova, Tennessee 38018
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Creve Coeur, Missouri 63141
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
Cromwell, Connecticut 06416
?
mi
from
Cromwell, CT
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75214
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Deerfield Beach, Florida 33064
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Doral, Florida 33166
?
mi
from
Doral, FL
Click here to add this to my saved trials
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...
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
East Providence, Rhode Island 02914
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Easton, MD
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
1125 N College Avenue West Tower
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Franklin, Tennessee 37064
?
mi
from
Franklin, TN
Click here to add this to my saved trials
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
1055 East 4th Avenue
Hialeah, Florida 33013
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33018
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Irvine, California 92618
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kissimmee, Florida 34759
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
La Habra, California 90631
?
mi
from
La Habra, CA
Click here to add this to my saved trials
Lake Worth, Florida 33449
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Lakewood, OH
Click here to add this to my saved trials
Las Vegas, Nevada 89144
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
?
mi
from
Levittown, PA
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Mansfield, Texas 76063
?
mi
from
Mansfield, TX
Click here to add this to my saved trials
?
mi
from
Marmora, NJ
Click here to add this to my saved trials
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33135
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33175
?
mi
from
Miami, FL
Click here to add this to my saved trials
286 Westward Drive
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
1830 Northwest 7th Street
Miami, Florida 33125
?
mi
from
Miami, FL
Click here to add this to my saved trials
1801 Coral Way
Miami, Florida 33133
?
mi
from
Miami, FL
Click here to add this to my saved trials
10346 West Flagler Street
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
3659 South Miami Avenue
Miami, Florida 33145
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33125
?
mi
from
Miami, FL
Click here to add this to my saved trials
11005 Southwest 84th Street
Miami, Florida 33183
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Arlington, New Jersey 07856
?
mi
from
Mount Arlington, NJ
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
300 Tower Road
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials