Efficacy and Safety of GTR in Comparison to Copaxone®

PHASE3CompletedINTERVENTIONAL
Enrollment

794

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Multiple Sclerosis
Interventions
DRUG

Glatiramer Acetate (GTR)

Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)

DRUG

Glatiramer Acetate (Copaxone®)

Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

DRUG

Placebo

Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Trial Locations (133)

Unknown

Synthon investigational site 112, Irvine

Synthon investigational site 120, Port Charlotte

Synthon investigational site 130, Sunrise

Synthon investigational site 107, Elk Grove Village

Synthon investigational site 141, Raleigh

Synthon investigational site 106, Cleveland

Synthon investigational site 135, Dayton

Synthon investigational site 401, Bitebsk

Synthon investigational site 403, Grodno

Synthon investigational site 402, Homyel

Synthon investigational site 404, Minsk

Synthon investigational site 407, Minsk

Synthon investigational site 408, Minsk

Synthon investigational site 405, Vitebsk

Synthon investigational site 486, Banja Luka

Synthon investigational site 487, Sarajevo

Synthon investigational site 488, Tuzla

Synthon investigational site 204, Pleven

Synthon investigational site 207, Pleven

Synthon investigational site 206, Plovdiv

Synthon investigational site 202, Sofia

Synthon investigational site 203, Sofia

Synthon investigational site 205, Sofia

Synthon investigational site 208, Sofia

Synthon investigational site 201, Varna

Synthon investigational site 477, Osijek

Synthon investigational site 475, Zagreb

Synthon investigational site 476, Zagreb

Synthon investigational site 478, Zagreb

Synthon investigational site 211, Brno

Synthon investigational site 217, Brno

Synthon investigational site 210, Olomouc

Synthon investigational site 212, Ostrava

Synthon investigational site 215, Prague

Synthon investigational site 216, Prague

Synthon investigational site 214, Teplice

Synthon investigational site 297, Kohtla-Järve

Synthon investigational site 296, Tallinn

Synthon investigational site 526, Tbilisi

Synthon investigational site 527, Tbilisi

Synthon investigational site 528, Tbilisi

Synthon investigational site 529, Tbilisi

Synthon investigational site 530, Tbilisi

Synthon investigational site 227, Jena

Synthon investigational site 234, Coppito

Synthon investigational site 235, Naples

Synthon investigational site 516, Guadalajara

Synthon investigational site 512, Mexico City

Synthon investigational site 514, Mexico City

Synthon investigational site 515, Morelia

Synthon investigational site 547, Chisinau

Synthon investigational site 548, Chisinau

Synthon investigational site 549, Chisinau

Synthon investigational site 550, Chisinau

Synthon investigational site 244, Bialystok

Synthon investigational site 240, Katowice

Synthon investigational site 241, Katowice

Synthon investigational site 242, Katowice

Synthon investigational site 245, Katowice

Synthon investigational site 247, Lodz

Synthon investigational site 251, Lublin

Synthon investigational site 243, Olsztyn

Synthon investigational site 248, Poznan

Synthon investigational site 250, Szczecin

Synthon investigational site 246, Warsaw

Synthon investigational site 249, Wroclaw

Synthon investigational site 260, Bucharest

Synthon investigational site 262, Bucharest

Synthon investigational site 263, Bucharest

Synthon investigational site 264, Bucharest

Synthon investigational site 265, Bucharest

Synthon investigational site 266, Cluj-Napoca

Synthon investigational site 267, Timișoara

Synthon investigational site 438, Arkhangelsk

Synthon investigational site 435, Barnaul

Synthon investigational site 437, Belgorod

Synthon investigational site 445, Kaluga

Synthon investigational site 427, Kazan'

Synthon investigational site 432, Kemerovo

Synthon investigational site 447, Kirov

Synthon investigational site 446, Lipetsk

Synthon investigational site 571, Moscow

Synthon investigational site 428, Nizhny Novgorod

Synthon investigational site 429, Nizhny Novgorod

Synthon investigational site 434, Novosibirsk

Synthon investigational site 442, Novosibirsk

Synthon investigational site 444, Penza

Synthon investigational site 433, Pyatigorsk

Synthon investigational site 421, Saint Petersburg

Synthon investigational site 426, Saint Petersburg

Synthon investigational site 430, Saint Petersburg

Synthon investigational site 440, Saint Petersburg

Synthon investigational site 424, Samara

Synthon investigational site 420, Smolensk

Synthon investigational site 422, Tomsk

Synthon investigational site 441, Tver'

Synthon investigational site 425, Tyumen

Synthon investigational site 423, Ufa

Synthon investigational site 431, Yekaterinburg

Synthon investigational site 450, Belgrade

Synthon investigational site 451, Belgrade

Synthon investigational site 453, Kragujevac

Synthon investigational site 452, Novi Sad

Synthon investigational site 501, Cape Town

Synthon investigational site 505, Durban

Synthon investigational site 502, Pretoria

Synthon investigational site 474, Cherkassy

Synthon investigational site 459, Chernihiv

Synthon investigational site 463, Chernivtsi

Synthon investigational site 458, Dnipro

Synthon investigational site 472, Dnipro

Synthon investigational site 464, Donetsk

Synthon investigational site 468, Donetsk

Synthon investigational site 495, Ivano-Frankivsk

Synthon investigational site 461, Kharkiv

Synthon investigational site 469, Kharkiv

Synthon investigational site 455, Kyiv

Synthon investigational site 456, Kyiv

Synthon investigational site 496, Kyiv

Synthon investigational site 473, Lutsk

Synthon investigational site 462, Lviv

Synthon investigational site 466, Lviv

Synthon investigational site 497, Lviv

Synthon investigational site 498, Mariupol

Synthon investigational site 457, Odesa

Synthon investigational site 470, Poltava

Synthon investigational site 471, Uzhhorod

Synthon investigational site 465, Vinnytsia

Synthon investigational site 460, Zhytomyr

Synthon investigational site 284, Sheffield

Synthon investigational site 281, Stoke-on-Trent

Synthon investigational site 283, Torquay

Synthon investigational site 280, Truro

All Listed Sponsors
lead

Synthon BV

INDUSTRY

NCT01489254 - Efficacy and Safety of GTR in Comparison to Copaxone® | Biotech Hunter | Biotech Hunter