NCT01862640View on ClinicalTrials.gov

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

PHASE3CompletedINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

July 11, 2013

Primary Completion Date

March 15, 2017

Study Completion Date

March 15, 2017

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

Brexpiprazole, OPC-34712

Once-daily, tablets

DRUG

Placebo Oral Tablet

Once-daily, tablets

Trial Locations (85)

10000

Zagreb

10090

Zagreb

11000

Belgrade

12209

Berlin

17190

Girona

18000

Niš

21000

Novi Sad

22083

Hamburg

23000

Zadar

23330

Novi Kneževac

26220

Kovin

26300

Vršac

26655

Westerstede

28034

Madrid

28040

Madrid

28049

Madrid

28601

Hickory

28832

Achim

28905

Getafe

30024

Suwanee

30033

Decatur

31014

Pamplona

33012

Hialeah

33013

Hialeah

33018

Hialeah

33024

Coconut Creek

33122

Miami

33126

Miami

33136

Miami

33137

Miami

33145

Miami

33161

Miami

33166

Miami Springs

33174

Miami

33319

Lauderhill

33647

Bielefeld

34000

Kragujevac

34239

Sarasota

35404

Tuscaloosa

36013

Poltava

37003

Salamanca

37064

Franklin

44791

Bochum

46010

Valencia

46026

Valencia

49021

Zamora

50935

Cologne

53188

Waukesha

57000

Rijeka

61068

Kharkiv

63128

St Louis

63141

St Louis

65006

Odesa

67513

Odesa

73118

Oklahoma City

73488

Kherson

73760

Ostfildern

76022

Bedford

79021

Lviv

85013

Phoenix

89148

Las Vegas

90706

Bellflower

Downey

92373

Redlands

92627

Costa Mesa

92868

Orange

92886

Yorba Linda

190000

Saint Petersburg

190005

Saint Petersburg

191119

Saint Petersburg

192019

Saint Petersburg

197341

Saint Petersburg

198510

Saint Petersburg

357034

Tonnel'nyy

410060

Saratov

443016

Samara

620030

Yekaterinburg

06851

Norwalk

02190

Weymouth

07856

Mount Arlington

08759

Paterson

08755

Toms River

09648

Mittweida

08028

Barcelona

04080

Kiev

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01862640 - A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation | Biotech Hunter | Biotech Hunter