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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Long Beach, California 90806
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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Gainesville, Florida 32610
(352) 392-3261
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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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
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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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
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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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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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109 Bee Street
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Charlotte, North Carolina 28211
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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Cincinnati, Ohio 45227
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Clinton, Utah 84015
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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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
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Danbury, Connecticut 06810
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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1125 N College Avenue West Tower
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1055 East 4th Avenue
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
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Indianapolis, Indiana 46256
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Irvine, California 92697
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Jacksonville, Florida 32216
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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630 W 168th St
New York, New York
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