Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

PHASE3CompletedINTERVENTIONAL
Enrollment

875

Participants

Timeline

Start Date

March 23, 2016

Primary Completion Date

April 10, 2017

Study Completion Date

April 10, 2017

Conditions
Migraine
Interventions
DRUG

Fremanezumab

"Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration.~The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site."

DRUG

Placebo

Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Trial Locations (275)

11803

Teva Investigational Site 13565, Plainview

14226

Teva Investigational Site 13576, Amherst

14800

Teva Investigational Site 54141, Kunratice

15401

Teva Investigational Site 13608, Uniontown

19046

Teva Investigational Site 13591, Jenkintown

19107

Teva Investigational Site 13554, Philadelphia

20100

Teva Investigational Site 40016, Turku

21208

Teva Investigational Site 13582, Pikesville

23454

Teva Investigational Site 13630, Virginia Beach

26506

Teva Investigational Site 13600, Morgantown

27401

Teva Investigational Site 13544, Greensboro

27408

Teva Investigational Site 13574, Greensboro

27607

Teva Investigational Site 13545, Raleigh

28046

Teva Investigational Site 31207, Madrid

29464

Teva Investigational Site 13556, Mt. Pleasant

29650

Teva Investigational Site 13615, Greer

30312

Teva Investigational Site 13620, Atlanta

30342

Teva Investigational Site 13537, Atlanta

31008

Teva Investigational Site 31208, Pamplona

32205

Teva Investigational Site 13559, Jacksonville

32607

Teva Investigational Site 13597, Gainesville

32806

Teva Investigational Site 13587, Orlando

33012

Teva Investigational Site 13607, Hialeah

33026

Teva Investigational Site 13553, Pembroke Pines

33407

Teva Investigational Site 13567, West Palm Beach

33781

Teva Investigational Site 13616, Pinellas Park

34201

Teva Investigational Site 13635, Bradenton

34471

Teva Investigational Site 13584, Ocala

35211

Teva Investigational Site 13628, Birmingham

35216

Teva Investigational Site 13577, Birmingham

37203

Teva Investigational Site 13532, Nashville

Teva Investigational Site 13552, Nashville

37620

Teva Investigational Site 13560, Bristol

40207

Teva Investigational Site 13566, Louisville

43212

Teva Investigational Site 13626, Columbus

44195

Teva Investigational Site 13569, Cleveland

44260

Teva Investigational Site 13625, Mogadore

44311

Teva Investigational Site 13609, Akron

Teva Investigational Site 13634, Akron

45227

Teva Investigational Site 13533, Cincinnati

45249

Teva Investigational Site 13624, Cincinnati

46254

Teva Investigational Site 13596, Indianapolis

47003

Teva Investigational Site 31205, Valladolid

48104

Teva Investigational Site 13539, Ann Arbor

50009

Teva Investigational Site 31206, Zaragoza

53002

Teva Investigational Site 54145, Pardubice

55422

Teva Investigational Site 13542, Golden Valley

58100

Teva Investigational Site 80096, Holon

60201

Teva Investigational Site 13627, Evanston

60607

Teva Investigational Site 13585, Chicago

60654

Teva Investigational Site 13621, Chicago

63141

Teva Investigational Site 13619, St Louis

64114

Teva Investigational Site 13534, Kansas City

64239

Teva Investigational Site 80095, Tel Aviv

67207

Teva Investigational Site 13617, Wichita

67211

Teva Investigational Site 13598, Wichita

68025

Teva Investigational Site 13618, Fremont

70006

Teva Investigational Site 13603, Metairie

72205

Teva Investigational Site 13602, Little Rock

73112

Teva Investigational Site 13561, Oklahoma City

75024

Teva Investigational Site 13611, Plano

75214

Teva Investigational Site 13623, Dallas

78229

Teva Investigational Site 13572, San Antonio

78731

Teva Investigational Site 13541, Austin

80014

Teva Investigational Site 13629, Aurora

80113

Teva Investigational Site 13631, Englewood

80210

Teva Investigational Site 13633, Denver

80239

Teva Investigational Site 13612, Denver

80301

Teva Investigational Site 13557, Boulder

80918

Teva Investigational Site 13593, Colorado Springs

83642

Teva Investigational Site 13604, Boise

84088

Teva Investigational Site 13581, West Jordan

84107

Teva Investigational Site 13614, Murray

85018

Teva Investigational Site 13606, Phoenix

85023

Teva Investigational Site 13579, Phoenix

87102

Teva Investigational Site 13588, Albuquerque

89106

Teva Investigational Site 13605, Las Vegas

90277

Teva Investigational Site 13571, Redondo Beach

90404

Teva Investigational Site 13538, Santa Monica

90806

Teva Investigational Site 13540, Long Beach

91316

Teva Investigational Site 13568, Encino

92103

Teva Investigational Site 13573, San Diego

92374

Teva Investigational Site 13632, Redlands

92835

Teva Investigational Site 13546, Fullerton

94598

Teva Investigational Site 13595, Walnut Creek

95405

Teva Investigational Site 13594, Santa Rosa

97401

Teva Investigational Site 13601, Eugene

98105

Teva Investigational Site 13564, Seattle

Teva Investigational Site 13586, Seattle

121467

Teva Investigational Site 50394, Moscow

129128

Teva Investigational Site 50400, Moscow

221001

Teva Investigational Site 80098, Nahariya

420012

Teva Investigational Site 50399, Kazan'

420021

Teva Investigational Site 50395, Kazan'

450007

Teva Investigational Site 50397, Ufa

603126

Teva Investigational Site 50398, Nizhny Novgorod

603137

Teva Investigational Site 50396, Nizhny Novgorod

4244916

Teva Investigational Site 80097, Netanya

5262160

Teva Investigational Site 80100, Ramat Gan

9112001

Teva Investigational Site 80099, Jerusalem

Unknown

Teva Investigational Site 13577, Birmingham

Teva Investigational Site 13628, Birmingham

Teva Investigational Site 13579, Phoenix

Teva Investigational Site 13606, Phoenix

Teva Investigational Site 13602, Little Rock

Teva Investigational Site 13568, Encino

Teva Investigational Site 13546, Fullerton

Teva Investigational Site 13540, Long Beach

Teva Investigational Site 13632, Redlands

Teva Investigational Site 13571, Redondo Beach

Teva Investigational Site 13573, San Diego

Teva Investigational Site 13538, Santa Monica

Teva Investigational Site 13594, Santa Rosa

Teva Investigational Site 13595, Walnut Creek

Teva Investigational Site 13629, Aurora

Teva Investigational Site 13557, Boulder

Teva Investigational Site 13593, Colorado Springs

Teva Investigational Site 13612, Denver

Teva Investigational Site 13633, Denver

Teva Investigational Site 13631, Englewood

Teva Investigational Site 13563, East Hartford

Teva Investigational Site 13550, Stamford

Teva Investigational Site 13635, Bradenton

Teva Investigational Site 13597, Gainesville

Teva Investigational Site 13607, Hialeah

Teva Investigational Site 13559, Jacksonville

Teva Investigational Site 13584, Ocala

Teva Investigational Site 13551, Orlando

Teva Investigational Site 13555, Orlando

Teva Investigational Site 13587, Orlando

Teva Investigational Site 13599, Orlando

Teva Investigational Site 13553, Pembroke Pines

Teva Investigational Site 13616, Pinellas Park

Teva Investigational Site 13567, West Palm Beach

Teva Investigational Site 13537, Atlanta

Teva Investigational Site 13620, Atlanta

Teva Investigational Site 13604, Meridian

Teva Investigational Site 13585, Chicago

Teva Investigational Site 13621, Chicago

Teva Investigational Site 13627, Evanston

Teva Investigational Site 13596, Indianapolis

Teva Investigational Site 13598, Wichita

Teva Investigational Site 13617, Wichita

Teva Investigational Site 13566, Louisville

Teva Investigational Site 13603, Metairie

Teva Investigational Site 13582, Baltimore

Teva Investigational Site 13590, Boston

Teva Investigational Site 13589, New Bedford

Teva Investigational Site 13543, Wellesley Hills

Teva Investigational Site 13539, Ann Arbor

Teva Investigational Site 13542, Golden Valley

Teva Investigational Site 13534, Kansas City

Teva Investigational Site 13536, Springfield

Teva Investigational Site 13619, St Louis

Teva Investigational Site 13618, Fremont

Teva Investigational Site 13605, Las Vegas

Teva Investigational Site 13578, Lebanon

Teva Investigational Site 13575, Martinsville

Teva Investigational Site 13588, Albuquerque

Teva Investigational Site 13576, Amherst

Teva Investigational Site 13565, Plainview

Teva Investigational Site 13544, Greensboro

Teva Investigational Site 13574, Greensboro

Teva Investigational Site 13545, Raleigh

Teva Investigational Site 13609, Akron

Teva Investigational Site 13634, Akron

Teva Investigational Site 13533, Cincinnati

Teva Investigational Site 13624, Cincinnati

Teva Investigational Site 13569, Cleveland

Teva Investigational Site 13626, Columbus

Teva Investigational Site 13625, Mogadore

Teva Investigational Site 13561, Oklahoma City

Teva Investigational Site 13601, Eugene

Teva Investigational Site 13591, Jenkintown

Teva Investigational Site 13554, Philadelphia

Teva Investigational Site 13608, Uniontown

Teva Investigational Site 13615, Greer

Teva Investigational Site 13556, Mt. Pleasant

Teva Investigational Site 13560, Bristol

Teva Investigational Site 13532, Nashville

Teva Investigational Site 13552, Nashville

Teva Investigational Site 13541, Austin

Teva Investigational Site 13623, Dallas

Teva Investigational Site 13611, Plano

Teva Investigational Site 13572, San Antonio

Teva Investigational Site 13614, Murray

Teva Investigational Site 13581, West Jordan

Teva Investigational Site 13630, Virginia Beach

Teva Investigational Site 13564, Seattle

Teva Investigational Site 13586, Seattle

Teva Investigational Site 13600, Morgantown

Teva Investigational Site 11124, Hamilton

Teva Investigational Site 11120, Calgary

Teva Investigational Site 11121, Montreal

Teva Investigational Site 11122, Newmarket

Teva Investigational Site 11123, Sarnia

Teva Investigational Site 54144, Brno

Teva Investigational Site 54141, Kunratice

Teva Investigational Site 54145, Pardubice

Teva Investigational Site 54143, Prague

Teva Investigational Site 54146, Prague

Teva Investigational Site 54142, Prague-4-Krc

Teva Investigational Site 40017, Helsinki

Teva Investigational Site 40018, Helsinki

Teva Investigational Site 40016, Turku

Teva Investigational Site 80096, Holon

Teva Investigational Site 80099, Jerusalem

Teva Investigational Site 80098, Nahariya

Teva Investigational Site 80097, Netanya

Teva Investigational Site 80100, Ramat Gan

Teva Investigational Site 80095, Tel Aviv

Teva Investigational Site 84064, Chofu-shi

Teva Investigational Site 84072, Chofu-shi

Teva Investigational Site 84066, Kagoshima

Teva Investigational Site 84069, Kaisho

Teva Investigational Site 84073, Kawasaki-shi

Teva Investigational Site 84067, Kyoto

Teva Investigational Site 84062, Osaka

Teva Investigational Site 84070, Saitama-shi

Teva Investigational Site 84061, Sendai

Teva Investigational Site 84065, Shimotsuma

Teva Investigational Site 84068, Shizuoka

Teva Investigational Site 84071, Toyonaka

Teva Investigational Site 84071, Toyonaka-shi

Teva Investigational Site 53363, Krakow

Teva Investigational Site 53364, Krakow

Teva Investigational Site 53366, Lublin

Teva Investigational Site 53365, Poznan

Teva Investigational Site 53367, Warsaw

Teva Investigational Site 50395, Kazan'

Teva Investigational Site 50399, Kazan'

Teva Investigational Site 50394, Moscow

Teva Investigational Site 50400, Moscow

Teva Investigational Site 50396, Nizhny Novgorod

Teva Investigational Site 50398, Nizhny Novgorod

Teva Investigational Site 50397, Ufa

Teva Investigational Site 31207, Madrid

Teva Investigational Site 31208, Pamplona

Teva Investigational Site 31205, Valladolid

Teva Investigational Site 31206, Zaragoza

06118

Teva Investigational Site 13563, East Hartford

06905

Teva Investigational Site 13550, Stamford

02131

Teva Investigational Site 13590, Boston

02301

Teva Investigational Site 13589, New Bedford

02481

Teva Investigational Site 13543, Wellesley Hills

03756

Teva Investigational Site 13578, Lebanon

08869

Teva Investigational Site 13575, Raritan

L8N 1Y2

Teva Investigational Site 11124, Hamilton

T3M 1M4

Teva Investigational Site 11120, Calgary

H2W 1V1

Teva Investigational Site 11121, Montreal

L3Y5G8

Teva Investigational Site 11122, Newmarket

N7T 4X3

Teva Investigational Site 11123, Sarnia

602 00

Teva Investigational Site 54144, Brno

100 00

Teva Investigational Site 54143, Prague

130 00

Teva Investigational Site 54146, Prague

140 59

Teva Investigational Site 54142, Prague

00100

Teva Investigational Site 40018, Helsinki

00930

Teva Investigational Site 40017, Helsinki

182-0006

Teva Investigational Site 84072, Chofu-shi

Teva Investigational Site 84064, Tokyo

892-0844

Teva Investigational Site 84066, Kagoshima

400-0124

Teva Investigational Site 84069, Kai

211-8588

Teva Investigational Site 84073, Kawasaki

600-8811

Teva Investigational Site 84067, Kyoto

556-0015

Teva Investigational Site 84062, Osaka

338-8577

Teva Investigational Site 84070, Saitama

982-0014

Teva Investigational Site 84061, Sendai

160-8582

Teva Investigational Site 84063, Shinjuku-ku

4200-853

Teva Investigational Site 84068, Shizuoka

321-0293

Teva Investigational Site 84065, Tochigi

31-523

Teva Investigational Site 53364, Krakow

33-332

Teva Investigational Site 53363, Krakow

20-022

Teva Investigational Site 53366, Lublin

60-529

Teva Investigational Site 53365, Poznan

04-730

Teva Investigational Site 53367, Warsaw

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT02629861 - Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine | Biotech Hunter | Biotech Hunter