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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01067521
First received: February 10, 2010
Last updated: February 24, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Parallel-group Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess Efficacy, Safety and Tolerability of Glatiramer Acetate Injection 40mg Compared to Placebo in a Double-blind Design

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The total number of confirmed relapses during the 12 month PC phase [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Status of Gd-enhancing T1 activity at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    =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
Study Start Date: May 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067521

  Hide Study Locations
Locations
United States, Arizona
Teva Investigational Site 1327
Gilbert, Arizona, United States
Teva Investigational Site 1311
Phoenix, Arizona, United States
United States, California
Teva Investigational Site 1326
Fullerton, California, United States
Teva Investigational Site 1335
La Jolla, California, United States
United States, Colorado
Teva Investigational Site 1297
Aurora, Colorado, United States
Teva Investigational Site 1344
Boulder, Colorado, United States
Teva Investigational Site 1315
Centennial, Colorado, United States
United States, Florida
Teva Investigational Site 1345
Miami, Florida, United States
Teva Investigational Site 1336
Naples, Florida, United States
Teva Investigational Site 1347
Pompano Beach, Florida, United States
Teva Investigational Site 1298
Sarasota, Florida, United States
Teva Investigational Site 1316
Sarasota, Florida, United States
Teva Investigational Site 1340
Tampa, Florida, United States
Teva Investigational Site 1317
Vero Beach, Florida, United States
United States, Illinois
Teva Investigational Site 1303
Northbrook, Illinois, United States
United States, Kentucky
Teva Investigational Site 1302
Lexington, Kentucky, United States
United States, Louisiana
Teva Investigational Site 1322
Shreveport, Louisiana, United States
United States, Michigan
Teva Investigational Site 1306
Detroit, Michigan, United States
United States, Ohio
Teva Investigational Site 1329
Akron, Ohio, United States
Teva Investigational Site 1349
Columbus, Ohio, United States
Teva Investigational Site 1313
Dayton, Ohio, United States
Teva Investigational Site 1318
Uniontown, Ohio, United States
United States, Oklahoma
Teva Investigational Site 1341
Oklahoma City, Oklahoma, United States
United States, Tennessee
Teva Investigational Site 1310
Nashville, Tennessee, United States
United States, Texas
Teva Investigational Site 1321
Lubbock, Texas, United States
Teva Investigational Site 1301
San Antonio, Texas, United States
Teva Investigational Site 1346
San Antonio, Texas, United States
United States, Utah
Teva Investigational Site 1343
Salt Lake City, Utah, United States
United States, Virginia
Teva Investigational Site 1338
Richmond, Virginia, United States
Teva Investigational Site 1339
Roanoke, Virginia, United States
Teva Investigational Site 1300
Vienna, Virginia, United States
United States, Washington
Teva Investigational Site 1323
Kirkland, Washington, United States
Bulgaria
Teva Investigational Site 5940
Blagoevgrad, Bulgaria
Teva Investigational Site 5931
Pleven, Bulgaria
Teva Investigational Site 5932
Pleven, Bulgaria
Teva Investigational Site 5933
Plovdiv, Bulgaria
Teva Investigational Site 5936
Ruse, Bulgaria
Teva Investigational Site 5935
Shumen, Bulgaria
Teva Investigational Site 5927
Sofia, Bulgaria
Teva Investigational Site 5921
Sofia, Bulgaria
Teva Investigational Site 5929
Sofia, Bulgaria
Teva Investigational Site 5922
Sofia, Bulgaria
Teva Investigational Site 5925
Sofia, Bulgaria
Teva Investigational Site 5924
Sofia, Bulgaria
Teva Investigational Site 5926
Sofia, Bulgaria
Teva Investigational Site 5923
Sofia, Bulgaria
Teva Investigational Site 5928
Sofia, Bulgaria
Teva Investigational Site 5939
Sofia, Bulgaria
Teva Investigational Site 5938
Sofia, Bulgaria
Teva Investigational Site 5934
Stara Zagora, Bulgaria
Teva Investigational Site 5930
Varna, Bulgaria
Teva Investigational Site 5937
Veliko Tarnovo, Bulgaria
Croatia
Teva Investigational Site 6011
Osijek, Croatia
Teva Investigational Site 6013
Zagreb, Croatia
Teva Investigational Site 6009
Zagreb, Croatia
Teva Investigational Site 6010
Zagreb, Croatia
Teva Investigational Site 6012
Zagreb, Croatia
Czech Republic
Teva Investigational Site 5433
Olomouc, Czech Republic
Teva Investigational Site 5434
Ostrava - poruba, Czech Republic
Teva Investigational Site 5435
Teplice, Czech Republic
Estonia
Teva Investigational Site 5513
Kohtla-Jaerve, Estonia
Teva Investigational Site 5510
Tallinn, Estonia
Teva Investigational Site 5512
Tartu, Estonia
Georgia
Teva Investigational Site 8111
Tbilisi, Georgia
Teva Investigational Site 8110
Tbilisi, Georgia
Germany
Teva Investigational Site 3268
Bad Wildbad, Germany
Teva Investigational Site 3272
Bayreuth, Germany
Teva Investigational Site 3276
Berlin, Germany
Teva Investigational Site 3262
Berlin, Germany
Teva Investigational Site 3265
Dresden, Germany
Teva Investigational Site 3263
Erbach, Germany
Teva Investigational Site 3266
Hannover, Germany
Teva Investigational Site 3270
Herborn, Germany
Teva Investigational Site 3275
Marburg, Germany
Teva Investigational Site 3264
Ulm, Germany
Hungary
Teva Investigational Site 5127
Budapest, Hungary
Teva Investigational Site 5129
Debrecen, Hungary
Teva Investigational Site 5130
Eger, Hungary
Teva Investigational Site 5132
Esztergom, Hungary
Teva Investigational Site 5131
Gyor, Hungary
Teva Investigational Site 5128
Kaposvar, Hungary
Teva Investigational Site 5133
Veszprem, Hungary
Israel
Teva Investigational Site 8052
Tel Hashomer, IL, Israel
Italy
Teva Investigational Site 3089
Bologna, Italy
Teva Investigational Site 3084
Cefalù (Palermo), Italy
Teva Investigational Site 3080
Milano, Italy
Teva Investigational Site 3086
Roma, Italy
Lithuania
Teva Investigational Site 5710
Kaunas, Lithuania
Teva Investigational Site 5712
Siauliai, Lithuania
Teva Investigational Site 5711
Vilnius, Lithuania
Poland
Teva Investigational Site 5374
Czestochowa, Poland
Teva Investigational Site 5377
Elblag, Poland
Teva Investigational Site 5380
Gdansk, Poland
Teva Investigational Site 5381
Gdansk, Poland
Teva Investigational Site 5376
Gorzow Wielkopolski, Poland
Teva Investigational Site 5372
Grodzisk Mazowiecki, Poland
Teva Investigational Site 5375
Katowice, Poland
Teva Investigational Site 5368
Katowice, Poland
Teva Investigational Site 5379
Kielce, Poland
Teva Investigational Site 5382
Konskie, Poland
Teva Investigational Site 5369
Koscierzyna, Poland
Teva Investigational Site 5378
Krakow, Poland
Teva Investigational Site 5366
Lodz, Poland
Teva Investigational Site 5373
Olsztyn, Poland
Teva Investigational Site 5384
Poznan, Poland
Teva Investigational Site 5371
Szczecin, Poland
Teva Investigational Site 5367
Warszawa, Poland
Teva Investigational Site 5370
Wroclaw, Poland
Romania
Teva Investigational Site 5233
Balotesti, Romania
Teva Investigational Site 5220
Bucuresti, Romania
Teva Investigational Site 5221
Bucuresti, Romania
Teva Investigational Site 5227
Cluj-Napoca, Romania
Teva Investigational Site 5230
Cluj-Napoca, Romania
Teva Investigational Site 5225
Constanta, Romania
Teva Investigational Site 5226
Constanta, Romania
Teva Investigational Site 5232
Craiova, Romania
Teva Investigational Site 5231
Iasi, Romania
Teva Investigational Site 5223
Piatra-Neamt, Romania
Teva Investigational Site 5228
Sibiu, Romania
Teva Investigational Site 5229
Targu-Mures, Romania
Teva Investigational Site 5224
Timisoara, Romania
Russian Federation
Teva Investigational Site 5063
Barnaul, Russian Federation
Teva Investigational Site 5059
Ekaterinburg, Russian Federation
Teva Investigational Site 5068
Irkutsk, Russian Federation
Teva Investigational Site 5067
Krasnoyarsk, Russian Federation
Teva Investigational Site 5052
Moscow, Russian Federation
Teva Investigational Site 5057
Nizhny Novgorod, Russian Federation
Teva Investigational Site 5062
Novosibirsk, Russian Federation
Teva Investigational Site 5060
Perm, Russian Federation
Teva Investigational Site 5053
Saint Petersburg, Russian Federation
Teva Investigational Site 5058
Samara, Russian Federation
Teva Investigational Site 5064
Smolensk, Russian Federation
Teva Investigational Site 5054
St. Petersburg, Russian Federation
Teva Investigational Site 5056
St. Petersburg, Russian Federation
Teva Investigational Site 5055
St. Petersburg, Russian Federation
Teva Investigational Site 5066
Tomsk, Russian Federation
Teva Investigational Site 5061
Ufa, Russian Federation
Teva Investigational Site 5065
Yaroslavl, Russian Federation
South Africa
Teva Investigational Site 9020
Johannesburg, South Africa
Teva Investigational Site 9022
Pietermaritzburg, South Africa
Teva Investigational Site 9018
Pretoria, South Africa
Teva Investigational Site 9021
Rosebank, South Africa
Ukraine
Teva Investigational Site 5835
Chernihiv, Ukraine
Teva Investigational Site 5834
Chernivtsi, Ukraine
Teva Investigational Site 5827
Dnipropetrovsk, Ukraine
Teva Investigational Site 5828
Donetsk, Ukraine
Teva Investigational Site 5829
Ivano-Frankivsk, Ukraine
Teva Investigational Site 5830
Kharkiv, Ukraine
Teva Investigational Site 5833
Kyiv, Ukraine
Teva Investigational Site 5836
Kyiv, Ukraine
Teva Investigational Site 5825
Lviv, Ukraine
Teva Investigational Site 5839
Odesa, Ukraine
Teva Investigational Site 5832
Poltava, Ukraine
Teva Investigational Site 5838
Simferopol, AR Crimea, Ukraine
Teva Investigational Site 5837
Uzhgorod, Ukraine
Teva Investigational Site 5826
Vinnytsya, Ukraine
Teva Investigational Site 5831
Zaporizhzhya, Ukraine
United Kingdom
Teva Investigational Site 3438
Salford, United Kingdom
Teva Investigational Site 3440
Sheffield, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01067521     History of Changes
Other Study ID Numbers: MS-GA-301
Study First Received: February 10, 2010
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Relapsing Remitting Multiple Sclerosis
Glatiramer Acetate

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 17, 2014