AzTrials
AzTrials

Relapsing Remitting Multiple SclerosisPhase 3GALANCT01067521

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

A Phase 3 study testing Glatiramer acetate (GA) in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 176 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 period. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing Remitting Multiple Sclerosis
What is being tested?
Glatiramer acetate (GA)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,404 participants
Where
176 sitesin 17 countries
Study dates
22 Jun 2010to 12 May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course.
  • Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
  • 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.
  • 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.
  • Subjects must be between 18 and 55 years of age, inclusive.
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  • Women of child-bearing potential must practice an acceptable method of birth control.
  • Subjects must be able to sign and date a written informed consent prior to entering the study.
  • Subjects must be willing and able to comply with the protocol requirements for the duration of the study

Who cannot join

  • Subjects with progressive forms of MS.
  • Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  • Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
  • Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
  • Use of cladribine within 2 years prior to screening.
  • Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
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  • Previous use of GA or any other glatiramoid.
  • Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
  • Previous total body irradiation or total lymphoid irradiation.
  • Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • Pregnancy or breastfeeding.
  • 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.
  • A known history of sensitivity to Gadolinium.
  • Inability to successfully undergo MRI scanning.
  • A known drug hypersensitivity to Mannitol.

Trial locations and contacts

176 sites in 17 countries.

176 sites in 17 countries

United States37 sites

  • Teva Investigational Site 1329

    Akron, Ohio, 44320

  • Teva Investigational Site 1297

    Aurora, Colorado, 80045

  • Teva Investigational Site 1332

    Birmingham, Alabama, 35209

  • Teva Investigational Site 1344

    Boulder, Colorado, 80304

  • Teva Investigational Site 1315

    Centennial, Colorado, 80112

  • Teva Investigational Site 1349

    Columbus, Ohio, 43221

  • Teva Investigational Site 1313

    Dayton, Ohio, 45417

  • Teva Investigational Site 1306

    Detroit, Michigan, 48201

  • Teva Investigational Site 1350

    Fort Collins, Colorado, 80528

  • Teva Investigational Site 1326

    Fullerton, California, 92835

  • Teva Investigational Site 1327

    Gilbert, Arizona, 85234

  • Teva Investigational Site 1323

    Kirkland, Washington, 98034

  • Teva Investigational Site 1335

    La Jolla, California, 92037

  • Teva Investigational Site 1334

    Lenexa, Kansas, 66214

  • Teva Investigational Site 1302

    Lexington, Kentucky, 40513

  • Teva Investigational Site 1321

    Lubbock, Texas, 79410

  • Teva Investigational Site 1345

    Miami, Florida, 33136

  • Teva Investigational Site 1336

    Naples, Florida, 34102

  • Teva Investigational Site 1310

    Nashville, Tennessee, 37205

  • Teva Investigational Site 1303

    Northbrook, Illinois, 60062

  • Teva Investigational Site 1341

    Oklahoma City, Oklahoma, 73104

  • Teva Investigational Site 1311

    Phoenix, Arizona, 85004

  • Teva Investigational Site 1347

    Pompano Beach, Florida, 33060

  • Teva Investigational Site 1319

    Ponte Vedra, Florida, 32082

  • Teva Investigational Site 1338

    Richmond, Virginia, 23298-0599

  • Teva Investigational Site 1339

    Roanoke, Virginia, 24018

  • Teva Investigational Site 1337

    Round Rock, Texas, 78681

  • Teva Investigational Site 1343

    Salt Lake City, Utah, 84106

  • Teva Investigational Site 1301

    San Antonio, Texas, 78231

  • Teva Investigational Site 1346

    San Antonio, Texas, 78258

  • Teva Investigational Site 1298

    Sarasota, Florida, 34233

  • Teva Investigational Site 1316

    Sarasota, Florida, 34239

  • Teva Investigational Site 1322

    Shreveport, Louisiana, 71103

  • Teva Investigational Site 1340

    Tampa, Florida, 33606

  • Teva Investigational Site 1318

    Uniontown, Ohio, 44685

  • Teva Investigational Site 1317

    Vero Beach, Florida, 32960

  • Teva Investigational Site 1300

    Vienna, Virginia, 22182

Other trials in United States

Bulgaria20 sites

  • Teva Investigational Site 5940

    Blagoevgrad, 2700

  • Teva Investigational Site 5931

    Pleven, 5800

  • Teva Investigational Site 5932

    Pleven, 5800

  • Teva Investigational Site 5933

    Plovdiv, 4000

  • Teva Investigational Site 5936

    Rousse, 7000

  • Teva Investigational Site 5935

    Shumen, 9700

  • Teva Investigational Site 5939

    Sofia, 1000

  • Teva Investigational Site 5921

    Sofia, 1113

  • Teva Investigational Site 5922

    Sofia, 1113

  • Teva Investigational Site 5926

    Sofia, 1309

  • Teva Investigational Site 5938

    Sofia, 1407

  • Teva Investigational Site 5924

    Sofia, 1431

  • Teva Investigational Site 5927

    Sofia, 15257

  • Teva Investigational Site 5923

    Sofia, 1606

  • Teva Investigational Site 5925

    Sofia, 1606

  • Teva Investigational Site 5928

    Sofia, 1606

  • Teva Investigational Site 5929

    Sofia, 1606

  • Teva Investigational Site 5934

    Stara Zagora, 6000

  • Teva Investigational Site 5930

    Varna, 9010

  • Teva Investigational Site 5937

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Poland18 sites

  • Teva Investigational Site 5374

    Częstochowa, 42-200

  • Teva Investigational Site 5377

    Elblag, 82-300

  • Teva Investigational Site 5381

    Gdansk, 80-299

  • Teva Investigational Site 5380

    Gdansk, 80-803

  • Teva Investigational Site 5382

    Gmina Końskie, 26-200

  • Teva Investigational Site 5376

    Gorzów Wielkopolski, 66-400

  • Teva Investigational Site 5372

    Grodzisk Mazowiecki, 05-825

  • Teva Investigational Site 5375

    Katowice, 40-684

  • Teva Investigational Site 5368

    Katowice, 40-752

  • Teva Investigational Site 5379

    Kielce, 25-726

  • Teva Investigational Site 5369

    Kościerzyna, 83-400

  • Teva Investigational Site 5378

    Krakow, 31-826

  • Teva Investigational Site 5366

    Lodz, 90-153

  • Teva Investigational Site 5373

    Olsztyn, 10-560

  • Teva Investigational Site 5384

    Poznan, 60-355

  • Teva Investigational Site 5371

    Szczecin, 70-111

  • Teva Investigational Site 5367

    Warsaw, 02-097

  • Teva Investigational Site 5370

    Wroclaw, 50-556

Other trials in Poland

Russia17 sites

  • Teva Investigational Site 5063

    Barnaul, 656024

  • Teva Investigational Site 5068

    Irkutsk, 664079

  • Teva Investigational Site 5067

    Krasnoyarsk, 660022

  • Teva Investigational Site 5052

    Moscow, 127015

  • Teva Investigational Site 5057

    Nizhny Novgorod, 603126

  • Teva Investigational Site 5062

    Novosibirsk, 630087

  • Teva Investigational Site 5060

    Perm, 614990

  • Teva Investigational Site 5056

    Saint Petersburg, 194044

  • Teva Investigational Site 5055

    Saint Petersburg, 194354

  • Teva Investigational Site 5053

    Saint Petersburg, 197022

  • Teva Investigational Site 5054

    Saint Petersburg, 197376

  • Teva Investigational Site 5058

    Samara, 443095

  • Teva Investigational Site 5064

    Smolensk, 214018

  • Teva Investigational Site 5066

    Tomsk, 634050

  • Teva Investigational Site 5061

    Ufa, 450007

  • Teva Investigational Site 5065

    Yaroslavl, 150030

  • Teva Investigational Site 5059

    Yekaterinburg, 620102

Other trials in Russia

Germany15 sites

  • Teva Investigational Site 3268

    Bad Wildbad, 75323

  • Teva Investigational Site 3272

    Bayreuth, 95445

  • Teva Investigational Site 3262

    Berlin, 10117

  • Teva Investigational Site 3276

    Berlin, 12203

  • Teva Investigational Site 3271

    Bonn, 53117

  • Teva Investigational Site 3265

    Dresden, 01307

  • Teva Investigational Site 3267

    Düsseldorf, 40211

  • Teva Investigational Site 3263

    Erbach im Odenwald, 64711

  • Teva Investigational Site 3269

    Hamburg, 22179

  • Teva Investigational Site 3266

    Hanover, 30171

  • Teva Investigational Site 3270

    Herborn, 35745

  • Teva Investigational Site 3273

    Kaltenkirchen, 24568

  • Teva Investigational Site 3275

    Marburg, 35043

  • Teva Investigational Site 3261

    Münster, 48149

  • Teva Investigational Site 3264

    Ulm, 89081

Other trials in Germany

Ukraine15 sites

  • Teva Investigational Site 5835

    Chernihiv, 14029

  • Teva Investigational Site 5834

    Chernivtsi, 58018

  • Teva Investigational Site 5827

    Dnipropetrovsk, 49027

  • Teva Investigational Site 5828

    Donetsk, 83003

  • Teva Investigational Site 5829

    Ivano-Frankivsk, 76008

  • Teva Investigational Site 5830

    Kharkiv, 61018

  • Teva Investigational Site 5833

    Kyiv, 03110

  • Teva Investigational Site 5836

    Kyiv, 03115

  • Teva Investigational Site 5825

    Lviv, 79010

  • Teva Investigational Site 5839

    Odesa, 65014

  • Teva Investigational Site 5832

    Poltava, 36024

  • Teva Investigational Site 5838

    Simferopol, 295017

  • Teva Investigational Site 5837

    Uzhhorod, 88018

  • Teva Investigational Site 5826

    Vinnytsia, 21005

  • Teva Investigational Site 5831

    Zaporizhzhya, 69600

Other trials in Ukraine

Romania14 sites

  • Teva Investigational Site 5233

    Baloteşti, 077015

  • Teva Investigational Site 5222

    Bucharest, 010825

  • Teva Investigational Site 5221

    Bucharest, 022328

  • Teva Investigational Site 5220

    Bucharest, 050098

  • Teva Investigational Site 5227

    Cluj-Napoca, 400006

  • Teva Investigational Site 5230

    Cluj-Napoca, 400437

  • Teva Investigational Site 5225

    Constanța, 900123

  • Teva Investigational Site 5226

    Constanța, 900591

  • Teva Investigational Site 5232

    Craiova, 200515

  • Teva Investigational Site 5231

    Iași, 700661

  • Teva Investigational Site 5223

    Piatra Neamţ, 610136

  • Teva Investigational Site 5228

    Sibiu, 550245

  • Teva Investigational Site 5229

    Târgu Mureş, 540136

  • Teva Investigational Site 5224

    Timișoara, 300736

Other trials in Romania

Hungary7 sites

  • Teva Investigational Site 5127

    Budapest, H-1115

  • Teva Investigational Site 5129

    Debrecen, 4043

  • Teva Investigational Site 5130

    Eger, H-3300

  • Teva Investigational Site 5132

    Esztergom, H-2500

  • Teva Investigational Site 5131

    Győr, H-9023

  • Teva Investigational Site 5128

    Kaposvár, H-7400

  • Teva Investigational Site 5133

    Veszprém, H-8200

Other trials in Hungary

South Africa7 sites

  • Teva Investigational Site 9020

    Johannesburg, 2157

  • Teva Investigational Site 9019

    Johannesburg, 2193

  • Teva Investigational Site 9022

    Pietermaritzburg, 3201

  • Teva Investigational Site 9025

    Pretoria, 0002

  • Teva Investigational Site 9018

    Pretoria, 0041

  • Teva Investigational Site 9021

    Rosebank, 2196

  • Teva Investigational Site 9024

    Umhlanga, 4320

Other trials in South Africa

Croatia5 sites

  • Teva Investigational Site 6011

    Osijek, 31 000

  • Teva Investigational Site 6009

    Zagreb, 10000

  • Teva Investigational Site 6010

    Zagreb, 10000

  • Teva Investigational Site 6012

    Zagreb, 10000

  • Teva Investigational Site 6013

    Zagreb, 10000

Other trials in Croatia

Italy5 sites

  • Teva Investigational Site 3089

    Bologna, 40139

  • Teva Investigational Site 3084

    Cefalù, 90015

  • Teva Investigational Site 3092

    Cosenza, 87100

  • Teva Investigational Site 3080

    Milan, 20148

  • Teva Investigational Site 3086

    Rome, 00144

Other trials in Italy

Czechia4 sites

  • Teva Investigational Site 5433

    Olomouc, 779 00

  • Teva Investigational Site 5434

    Ostrava - Poruba, 708 52

  • Teva Investigational Site 5432

    Prague, 100 31

  • Teva Investigational Site 5435

    Teplice, 415 29

Other trials in Czechia

Estonia3 sites

  • Teva Investigational Site 5513

    Kohtla-Järve, 31025

  • Teva Investigational Site 5510

    Tallinn, EE-10617

  • Teva Investigational Site 5512

    Tartu, EE-51014

Other trials in Estonia

Lithuania3 sites

  • Teva Investigational Site 5710

    Kaunas, 50009

  • Teva Investigational Site 5712

    Šiauliai, 76231

  • Teva Investigational Site 5711

    Vilnius, LT-08661

Other trials in Lithuania

United Kingdom3 sites

  • Teva Investigational Site 3439

    Nottingham, NG7 2UH

  • Teva Investigational Site 3438

    Salford, M6 8HD

  • Teva Investigational Site 3440

    Sheffield, S10 2JF

Other trials in United Kingdom

Georgia2 sites

  • Teva Investigational Site 8110

    Tbilisi, 0112

  • Teva Investigational Site 8111

    Tbilisi, 0179

Other trials in Georgia

Israel1 site

  • Teva Investigational Site 8052

    Ramat Gan, 5262160

Other trials in Israel

About this study

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

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 period. The study has two periods:

  • Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
  • Open Label Extension Period: 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
Read the detailed description

Participants who were randomized to the GA 40 mg treatment arm in the Double-Blind Period, continue that treatment in the Open-Label Extension Period and are referred to as "Early Start" participants. Participants randomized to the Placebo arm in the Double-Blind Period and switched to GA 40 mg subcutaneous injections three times a week in the Open-Label Extension are referred to as "Delayed Start" participants.

Being tested
Glatiramer acetate (GA), Placebo
Keywords
Relapsing Remitting Multiple Sclerosis, Glatiramer Acetate
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glatiramer acetate (GA)Drug

    Also called Copaxone

    GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period.

  • PlaceboDrug

    Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.

Study groups in NCT01067521
Study groupRoleWhat they receive
GA 40 mg / GA 40 mgExperimentalAlso referred to as the 'Early Start' treatment arm, participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the Double-Blind Period, and then continued that treatment as open-label therapy until the drug was commercially available or development stopped.
Receives: Drug: Glatiramer acetate (GA)
Placebo / GA 40 mgPlacebo comparatorAlso referred to as the 'Delayed Start' treatment arm, participants were administered placebo subcutaneous injections three times a week for 12 months during the Double-Blind Period, and then switched to GA 40 mg/mL subcutaneous injections three times a week as open-label therapy until the drug was commercially available or development stopped.
Receives: Drug: Glatiramer acetate (GA); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression

    Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting >= 48 hours and immediately preceded by an improving neurological state of at >=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with >= one of the following: - An increase of >= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of >=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.

    Measured: Day 1 to 12 months

  2. Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression

    The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an "offset" based on the log of exposure to treatment.

    Measured: Day 1 up to 6.5 years

Secondary outcomes (7)

  1. The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression

    T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The cumulative number of T2 lesions at Months 6 and 12 that are new or enlarged as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates.

    Measured: Baseline (Day -7), Month 6, Month 12

  2. The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression

    The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6 and 12 as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression with an "offset" employing the log of the proportion of the number of the available post-baseline scans to adjust for missing MRI scans (if any), adjusted for baseline number of enhancing lesions on T1-weighted images and country or geographical region as covariates.

    Measured: Baseline (Day -7), Month 6, Month 12

  3. Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period

    The analysis of brain atrophy as defined by the percentage change in normalized brain volume from baseline to Month 12 was based on the outcome of a contrast (GA 40 mg TIW vs. placebo) derived from a baseline-adjusted ANCOVA. In addition to the treatment group, the model included the following covariates: - SIENAX normalized brain volume at baseline. - The number of enhancing lesions on T1-weighted images at baseline. - country or geographical region.

    Sienax estimates total brain tissue volume, from a single image, normalised for skull size.

    Measured: Baseline (Day -7), Month 12

  4. The Number of New/Enlarging T2 Lesions at Months 6, 12 and 36 Estimated by Negative Binomial Regression

    All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The number of T2 lesions at Months 6, 12 and 36 that are new or enlarged as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates. An "offset" employing the log of the proportion of the number of the available post-placebo-controlled baseline (PCBL) scans was used to adjust for missing MRI scans.

    Measured: Baseline (Day -7), Month 6, Month 12, Month 36

  5. The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Months 6, 12 and 36 Estimated by Negative Binomial Regression

    All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6, 12 and 36 as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression The model was fit using an autoregressive covariance structure. Covariates used: number of enhancing lesions on T1-weighted images at placebo-controlled baseline and country or geographical region. The cumulative number is derived from all the data points before it. For example, if the participant skipped one time point in between the baseline and 36 months, then it cannot be calculated.

    Measured: Baseline (Day -7), Month 6, Month 12, Month 36

  6. Brain Atrophy As Defined by the Percent of Change in Brain Volume From Baseline to Months 6, 12 and 36 Estimated by a Mixed Model for Repeated Measures

    The analysis of brain atrophy as defined by the percentage change in brain volume from baseline to Months 6, 12 and 36 was performed using mixed model for repeated measures (MMRM) with SIENAX normalized brain volume at baseline, number of Gd-enhancing lesions at baseline, and country or geographical region as fixed effects.

    Sienax estimates total brain tissue volume, from a single image, normalised for skull size.

    Measured: Baseline (Day -7), Month 6, Month 12, Month 36

  7. Participants With Treatment-Emergent Adverse Events (TEAEs)

    Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Early Start: Day 1 up to 6.5 years Delayed Start - Placebo: Day 1 up to Month 12 Delayed Start - GA: Month 13 up to 6.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2010 (estimated)
  2. Study start22 Jun 2010
  3. Primary completion8 May 2012
  4. Study completion12 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067521
Sponsor's protocol ID
MS-GA-301
Other IDs
2009-018084-27, 2009
Acronym
GALA
Status last verified
Dec 2021
First submitted
10 Feb 2010
Last updated
9 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khan O, Rieckmann P, Boyko A, Selmaj K, Ashtamker N, Davis MD, Kolodny S, Zivadinov R. Efficacy and safety of a three-times-weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-Frequency Administration open-label extension study. Mult Scler. 2017 May;23(6):818-829. doi: 10.1177/1352458516664033. Epub 2016 Aug 8.

    PubMed 27503905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glatiramer acetate (GA) in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 176 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Bulgaria, Poland, Russia, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (time frame: Day 1 to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01067521, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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