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A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo (GALA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067521
First Posted: February 11, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
  Purpose

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled phase. The study has two phases:

  • Placebo Controlled Phase: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
  • Open Label Extension: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: Glatiramer acetate (GA) Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):

Primary Outcome Measures:
  • The total number of confirmed relapses during the 12 month PC phase [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. [ Time Frame: 12 months ]
  • The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ]
  • Status of Gd-enhancing T1 activity at baseline [ Time Frame: Baseline ]
    =0 if the subject has no Gd-enhancing T1 lesions at baseline; =1 if the subject has at least one Gd-enhancing T1 lesion at baseline


Enrollment: 1404
Actual Study Start Date: May 31, 2010
Study Completion Date: May 12, 2017
Primary Completion Date: May 7, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GA 40 mg Drug: Glatiramer acetate (GA)
GA 40 mg administered 3 times a week by subcutaneous injection for a period of 12 months
Placebo Comparator: Placebo Other: Placebo
Placebo comparator

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course.
  2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
  3. Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or ACTH 30 days prior to screening (month -1) and between screening and baseline (month 0) visits.
  4. Subjects must have experienced one of the following:

    At least one documented relapse in the 12 months prior to screening, or At least two documented relapses in the 24 months prior to screening, or One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.

  5. Subjects must be between 18 and 55 years of age, inclusive.
  6. Women of child-bearing potential must practice an acceptable method of birth control.
  7. Subjects must be able to sign and date a written informed consent prior to entering the study.
  8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria:

  1. Subjects with progressive forms of MS.
  2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
  4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
  5. Use of cladribine within 2 years prior to screening.
  6. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
  7. Previous use of GA or any other glatiramoid.
  8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
  9. Previous total body irradiation or total lymphoid irradiation.
  10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  11. Pregnancy or breastfeeding.
  12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
  13. A known history of sensitivity to Gadolinium.
  14. Inability to successfully undergo MRI scanning.
  15. A known drug hypersensitivity to Mannitol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067521


  Hide Study Locations
Locations
United States, Alabama
Teva Investigational Site 1332
Birmingham, Alabama, United States, 35209
United States, Arizona
Teva Investigational Site 1327
Gilbert, Arizona, United States, 85234
Teva Investigational Site 1311
Phoenix, Arizona, United States, 85004
United States, California
Teva Investigational Site 1326
Fullerton, California, United States, 92835
Teva Investigational Site 1335
La Jolla, California, United States, 92037
United States, Colorado
Teva Investigational Site 1297
Aurora, Colorado, United States, 80045
Teva Investigational Site 1344
Boulder, Colorado, United States, 80304
Teva Investigational Site 1315
Centennial, Colorado, United States, 80112
Teva Investigational Site 1350
Fort Collins, Colorado, United States, 80528
United States, Florida
Teva Investigational Site 1345
Miami, Florida, United States, 33136
Teva Investigational Site 1336
Naples, Florida, United States, 34102
Teva Investigational Site 1347
Pompano Beach, Florida, United States, 33060
Teva Investigational Site 1319
Ponte Vedra, Florida, United States, 32082
Teva Investigational Site 1298
Sarasota, Florida, United States, 34233
Teva Investigational Site 1316
Sarasota, Florida, United States, 34239
Teva Investigational Site 1340
Tampa, Florida, United States, 33606
Teva Investigational Site 1317
Vero Beach, Florida, United States, 32960
United States, Illinois
Teva Investigational Site 1303
Northbrook, Illinois, United States, 60062
United States, Kansas
Teva Investigational Site 1334
Lenexa, Kansas, United States, 66214
United States, Kentucky
Teva Investigational Site 1302
Lexington, Kentucky, United States, 40513
United States, Louisiana
Teva Investigational Site 1322
Shreveport, Louisiana, United States, 71103
United States, Michigan
Teva Investigational Site 1306
Detroit, Michigan, United States, 48201
United States, Ohio
Teva Investigational Site 1329
Akron, Ohio, United States, 44320
Teva Investigational Site 1349
Columbus, Ohio, United States, 43221
Teva Investigational Site 1313
Dayton, Ohio, United States, 45417
Teva Investigational Site 1318
Uniontown, Ohio, United States, 44685
United States, Oklahoma
Teva Investigational Site 1341
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Teva Investigational Site 1310
Nashville, Tennessee, United States, 37205
United States, Texas
Teva Investigational Site 1321
Lubbock, Texas, United States, 79410
Teva Investigational Site 1337
Round Rocks, Texas, United States, 78681
Teva Investigational Site 1301
San Antonio, Texas, United States, 78231
Teva Investigational Site 1346
San Antonio, Texas, United States, 78258
United States, Utah
Teva Investigational Site 1343
Salt Lake City, Utah, United States, 84106
United States, Virginia
Teva Investigational Site 1338
Richmond, Virginia, United States, 23298-0599
Teva Investigational Site 1339
Roanoke, Virginia, United States, 24018
Teva Investigational Site 1300
Vienna, Virginia, United States, 22182
United States, Washington
Teva Investigational Site 1323
Kirkland, Washington, United States, 98034
Bulgaria
Teva Investigational Site 5940
Blagoevgrad, Bulgaria, 2700
Teva Investigational Site 5931
Pleven, Bulgaria, 5800
Teva Investigational Site 5932
Pleven, Bulgaria, 5800
Teva Investigational Site 5933
Plovdiv, Bulgaria, 4000
Teva Investigational Site 5936
Ruse, Bulgaria, 7000
Teva Investigational Site 5935
Shumen, Bulgaria, 9700
Teva Investigational Site 5939
Sofia, Bulgaria, 1000
Teva Investigational Site 5921
Sofia, Bulgaria, 1113
Teva Investigational Site 5922
Sofia, Bulgaria, 1113
Teva Investigational Site 5926
Sofia, Bulgaria, 1309
Teva Investigational Site 5938
Sofia, Bulgaria, 1407
Teva Investigational Site 5924
Sofia, Bulgaria, 1431
Teva Investigational Site 5927
Sofia, Bulgaria, 1527
Teva Investigational Site 5923
Sofia, Bulgaria, 1606
Teva Investigational Site 5925
Sofia, Bulgaria, 1606
Teva Investigational Site 5928
Sofia, Bulgaria, 1606
Teva Investigational Site 5929
Sofia, Bulgaria, 1606
Teva Investigational Site 5934
Stara Zagora, Bulgaria, 6000
Teva Investigational Site 5930
Varna, Bulgaria, 9010
Teva Investigational Site 5937
Veliko Tarnovo, Bulgaria, 5000
Croatia
Teva Investigational Site 6011
Osijek, Croatia, 31 000
Teva Investigational Site 6009
Zagreb, Croatia, 10000
Teva Investigational Site 6010
Zagreb, Croatia, 10000
Teva Investigational Site 6012
Zagreb, Croatia, 10000
Teva Investigational Site 6013
Zagreb, Croatia, 10000
Czechia
Teva Investigational Site 5433
Olomouc, Czechia, 779 00
Teva Investigational Site 5434
Ostrava - poruba, Czechia, 708 52
Teva Investigational Site 5432
Praha 10, Czechia, 100 31
Teva Investigational Site 5435
Teplice, Czechia, 415 29
Estonia
Teva Investigational Site 5513
Kohtla-Jarve, Estonia, 31025
Teva Investigational Site 5510
Tallinn, Estonia, EE-10617
Teva Investigational Site 5512
Tartu, Estonia, EE-51014
Georgia
Teva Investigational Site 8110
Tbilisi, Georgia, 0112
Teva Investigational Site 8111
Tbilisi, Georgia, 0179
Germany
Teva Investigational Site 3268
Bad Wildbad, Germany, 75323
Teva Investigational Site 3272
Bayreuth, Germany, 95445
Teva Investigational Site 3262
Berlin, Germany, 10117
Teva Investigational Site 3276
Berlin, Germany, 12203
Teva Investigational Site 3271
Bonn, Germany, 53117
Teva Investigational Site 3265
Dresden, Germany, 01307
Teva Investigational Site 3267
Duesseldorf, Germany, 40211
Teva Investigational Site 3263
Erbach, Germany, 64711
Teva Investigational Site 3269
Hamburg, Germany, 22179
Teva Investigational Site 3266
Hannover, Germany, 30171
Teva Investigational Site 3270
Herborn, Germany, 35745
Teva Investigational Site 3273
Kaltenkirchen, Germany, 24568
Teva Investigational Site 3275
Marburg, Germany, 35043
Teva Investigational Site 3261
Muenster, Germany, 48149
Teva Investigational Site 3264
Ulm, Germany, 89081
Hungary
Teva Investigational Site 5127
Budapest, Hungary, H-1115
Teva Investigational Site 5129
Debrecen, Hungary, 4043
Teva Investigational Site 5130
Eger, Hungary, H-3300
Teva Investigational Site 5132
Esztergom, Hungary, H-2500
Teva Investigational Site 5131
Gyor, Hungary, H-9023
Teva Investigational Site 5128
Kaposvar, Hungary, H-7400
Teva Investigational Site 5133
Veszprem, Hungary, H-8200
Israel
Teva Investigational Site 8052
Ramat Gan, Israel, 5262160
Italy
Teva Investigational Site 3089
Bologna, Italy, 40139
Teva Investigational Site 3084
Cefalu, Italy, 90015
Teva Investigational Site 3092
Cosenza, Italy, 87100
Teva Investigational Site 3080
Milano, Italy, 20148
Teva Investigational Site 3086
Rome, Italy, 00144
Lithuania
Teva Investigational Site 5710
Kaunas, Lithuania, 50009
Teva Investigational Site 5712
Siauliai, Lithuania, 76231
Teva Investigational Site 5711
Vilnius, Lithuania, LT-08661
Poland
Teva Investigational Site 5374
Czestochowa, Poland, 42-200
Teva Investigational Site 5377
Elblag, Poland, 82-300
Teva Investigational Site 5381
Gdansk, Poland, 80-299
Teva Investigational Site 5380
Gdansk, Poland, 80-803
Teva Investigational Site 5376
Gorzow Wielkopolski, Poland, 66-400
Teva Investigational Site 5372
Grodzisk Mazowiecki, Poland, 05-825
Teva Investigational Site 5375
Katowice, Poland, 40-684
Teva Investigational Site 5368
Katowice, Poland, 40-752
Teva Investigational Site 5379
Kielce, Poland, 25-726
Teva Investigational Site 5382
Konskie, Poland, 26-200
Teva Investigational Site 5369
Koscierzyna, Poland, 83-400
Teva Investigational Site 5378
Krakow, Poland, 31-826
Teva Investigational Site 5366
Lodz, Poland, 90-153
Teva Investigational Site 5373
Olsztyn, Poland, 10-560
Teva Investigational Site 5384
Poznan, Poland, 60-355
Teva Investigational Site 5371
Szczecin, Poland, 70-111
Teva Investigational Site 5367
Warszawa, Poland, 02-097
Teva Investigational Site 5370
Wroclaw, Poland, 50-556
Romania
Teva Investigational Site 5233
Balotesti, Romania, 077015
Teva Investigational Site 5222
Bucharest, Romania, 010825
Teva Investigational Site 5221
Bucuresti, Romania, 022328
Teva Investigational Site 5220
Bucuresti, Romania, 050098
Teva Investigational Site 5227
Cluj-Napoca, Romania, 400006
Teva Investigational Site 5230
Cluj-Napoca, Romania, 400437
Teva Investigational Site 5225
Constanta, Romania, 900123
Teva Investigational Site 5226
Constanta, Romania, 900591
Teva Investigational Site 5232
Craiova, Romania, 200515
Teva Investigational Site 5231
Iasi, Romania, 700661
Teva Investigational Site 5223
Piatra-Neamt, Romania, 610136
Teva Investigational Site 5228
Sibiu, Romania, 550245
Teva Investigational Site 5229
Targu-Mures, Romania, 540136
Teva Investigational Site 5224
Timisoara, Romania, 300736
Russian Federation
Teva Investigational Site 5063
Barnaul, Russian Federation, 656024
Teva Investigational Site 5059
Ekaterinburg, Russian Federation, 620102
Teva Investigational Site 5068
Irkutsk, Russian Federation, 664079
Teva Investigational Site 5067
Krasnoyarsk, Russian Federation, 660022
Teva Investigational Site 5052
Moscow, Russian Federation, 127015
Teva Investigational Site 5057
Nizhny Novgorod, Russian Federation, 603126
Teva Investigational Site 5062
Novosibirsk, Russian Federation, 630087
Teva Investigational Site 5060
Perm, Russian Federation, 614990
Teva Investigational Site 5053
Saint Petersburg, Russian Federation, 197022
Teva Investigational Site 5058
Samara, Russian Federation, 443095
Teva Investigational Site 5064
Smolensk, Russian Federation, 214018
Teva Investigational Site 5056
St. Petersburg, Russian Federation, 194044
Teva Investigational Site 5055
St. Petersburg, Russian Federation, 194354
Teva Investigational Site 5054
St. Petersburg, Russian Federation, 197376
Teva Investigational Site 5066
Tomsk, Russian Federation, 634050
Teva Investigational Site 5061
Ufa, Russian Federation, 450007
Teva Investigational Site 5065
Yaroslavl, Russian Federation, 150030
South Africa
Teva Investigational Site 9020
Johannesburg, South Africa, 2157
Teva Investigational Site 9019
Johannesburg, South Africa, 2193
Teva Investigational Site 9022
Pietermaritzburg, South Africa, 3201
Teva Investigational Site 9025
Pretoria, South Africa, 0002
Teva Investigational Site 9018
Pretoria, South Africa, 0041
Teva Investigational Site 9021
Rosebank, South Africa, 2196
Teva Investigational Site 9024
Umhlanga, South Africa, 4320
Ukraine
Teva Investigational Site 5835
Chernihiv, Ukraine, 14029
Teva Investigational Site 5834
Chernivtsi, Ukraine, 58018
Teva Investigational Site 5827
Dnipropetrovsk, Ukraine, 49027
Teva Investigational Site 5828
Donetsk, Ukraine, 83003
Teva Investigational Site 5829
Ivano-Frankivsk, Ukraine, 76008
Teva Investigational Site 5830
Kharkiv, Ukraine, 61018
Teva Investigational Site 5833
Kyiv, Ukraine, 03110
Teva Investigational Site 5836
Kyiv, Ukraine, 03115
Teva Investigational Site 5825
Lviv, Ukraine, 79010
Teva Investigational Site 5839
Odesa, Ukraine, 65014
Teva Investigational Site 5832
Poltava, Ukraine, 36024
Teva Investigational Site 5838
Simferopol, Ukraine, 295017
Teva Investigational Site 5837
Uzhgorod, Ukraine, 88018
Teva Investigational Site 5826
Vinnytsya, Ukraine, 21005
Teva Investigational Site 5831
Zaporizhzhya, Ukraine, 69600
United Kingdom
Teva Investigational Site 3439
Nottingham, United Kingdom, NG7 2UH
Teva Investigational Site 3438
Salford, United Kingdom, M6 8HD
Teva Investigational Site 3440
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT01067521     History of Changes
Other Study ID Numbers: MS-GA-301
2009-018084-27 ( EudraCT Number )
First Submitted: February 10, 2010
First Posted: February 11, 2010
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):
Relapsing Remitting Multiple Sclerosis
Glatiramer Acetate

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents