Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

PHASE3CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Agitation Associated WithAlzheimer's DiseaseAlzheimer's TypeMental DisorderNervous System Diseases
Interventions
DRUG

Brexpiprazole, OPC-34712

Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks

Trial Locations (70)

1000

Ljubljana

1113

Sofia

1154

Sofia

1431

Sofia

2000

Maribor

4400

Pazardzhik

5000

Veliko Tarnovo

5290

Šempeter pri Gorici

6600

Kardzhali

7003

Rousse

8000

Burgas

9020

Varna

11040

New Hyde Park

11214

Brooklyn

14215

Buffalo

20520

Turku

21005

Vinnytsia

27609

Raleigh

28270

Charlotte

30080

Smyrna

30331

Atlanta

31059

Toulouse

32763

Orange City

33142

Miami

33165

Miami

33176

Miami

34205

Bradenton

36013

Poltava

46256

Indianapolis

48105

Ann Arbor

59500

Douai

61068

Kharkiv

70210

Kuopio

73488

Kherson

75231

Dallas

75243

Dallas

78757

Austin

78990

Élancourt

79021

Lviv

80209

Denver

83037

Donetsk

87042

Limoges

90806

Long Beach

90822

Long Beach

91402

Panorama City

91950

Universal City

92251

Imperial

95006

Simferopol

96817

Honolulu

188820

Saint Petersburg

190005

Saint Petersburg

195176

Saint Petersburg

197341

Saint Petersburg

357034

Tonnel’nyy

410060

Saratov

620030

Yekaterinburg

08755

Lakewood

02169

Quincy

02747

South Dartmouth

05091

Woodstock

V2A 4M4

Penticton

B4N 4K9

Kentville

01012

Bourg-en-Bresse

06100

Nice

04080

Kiev

04114

Kiev

CW1 2ER

Crewe

M8 5RB

Manchester

CT20 1JY

Margate

PL11 2TB

Torpoint

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01922258 - Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type | Biotech Hunter | Biotech Hunter