Back to results

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)

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Glatiramer acetate (GA)

Placebo

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Relapsing Remitting Multiple Sclerosis, Glatiramer Acetate

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GA 40 mg / GA 40 mg

Placebo / GA 40 mg

Arm Description

Also 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.

Also 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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01067521

First Posted

February 10, 2010

Last Updated

December 7, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01067521

Brief Title

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

Acronym

GALA

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

June 22, 2010 (Actual)

Primary Completion Date

May 8, 2012 (Actual)

Study Completion Date

May 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis, Glatiramer Acetate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GA 40 mg / GA 40 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo / GA 40 mg

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Glatiramer acetate (GA)

Other Intervention Name(s)

Copaxone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Day 1 to 12 months

Title

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

Description

Time Frame

Day 1 up to 6.5 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline (Day -7), Month 12

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

Teva Investigational Site 1332

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Teva Investigational Site 1327

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Teva Investigational Site 1311

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Teva Investigational Site 1326

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Teva Investigational Site 1335

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Teva Investigational Site 1297

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Teva Investigational Site 1344

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Teva Investigational Site 1315

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Teva Investigational Site 1350

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Teva Investigational Site 1345

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Teva Investigational Site 1336

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Teva Investigational Site 1347

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

Country

United States

Facility Name

Teva Investigational Site 1319

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32082

Country

United States

Facility Name

Teva Investigational Site 1298

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Facility Name

Teva Investigational Site 1316

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Teva Investigational Site 1340

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Teva Investigational Site 1317

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Teva Investigational Site 1303

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Teva Investigational Site 1334

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

Teva Investigational Site 1302

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

Teva Investigational Site 1322

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71103

Country

United States

Facility Name

Teva Investigational Site 1306

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Teva Investigational Site 1329

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Teva Investigational Site 1349

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

Teva Investigational Site 1313

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Teva Investigational Site 1318

City

Uniontown

State/Province

Ohio

ZIP/Postal Code

44685

Country

United States

Facility Name

Teva Investigational Site 1341

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Teva Investigational Site 1310

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Teva Investigational Site 1321

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Teva Investigational Site 1337

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Teva Investigational Site 1301

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Teva Investigational Site 1346

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Teva Investigational Site 1343

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Teva Investigational Site 1338

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0599

Country

United States

Facility Name

Teva Investigational Site 1339

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

Teva Investigational Site 1300

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22182

Country

United States

Facility Name

Teva Investigational Site 1323

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Teva Investigational Site 5940

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

Teva Investigational Site 5931

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 5932

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Teva Investigational Site 5933

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Teva Investigational Site 5936

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Teva Investigational Site 5935

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Teva Investigational Site 5939

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Teva Investigational Site 5921

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Teva Investigational Site 5922

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Teva Investigational Site 5926

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Teva Investigational Site 5938

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Teva Investigational Site 5924

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Teva Investigational Site 5927

City

Sofia

ZIP/Postal Code

15257

Country

Bulgaria

Facility Name

Teva Investigational Site 5923

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 5925

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 5928

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 5929

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Teva Investigational Site 5934

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Teva Investigational Site 5930

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Teva Investigational Site 5937

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Teva Investigational Site 6011

City

Osijek

ZIP/Postal Code

31 000

Country

Croatia

Facility Name

Teva Investigational Site 6009

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Teva Investigational Site 6010

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Teva Investigational Site 6012

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Teva Investigational Site 6013

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Teva Investigational Site 5433

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Teva Investigational Site 5434

City

Ostrava - poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Teva Investigational Site 5432

City

Prague 10

ZIP/Postal Code

100 31

Country

Czechia

Facility Name

Teva Investigational Site 5435

City

Teplice

ZIP/Postal Code

415 29

Country

Czechia

Facility Name

Teva Investigational Site 5513

City

Kohtla-Jarve

ZIP/Postal Code

31025

Country

Estonia

Facility Name

Teva Investigational Site 5510

City

Tallinn

ZIP/Postal Code

EE-10617

Country

Estonia

Facility Name

Teva Investigational Site 5512

City

Tartu

ZIP/Postal Code

EE-51014

Country

Estonia

Facility Name

Teva Investigational Site 8110

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

Teva Investigational Site 8111

City

Tbilisi

ZIP/Postal Code

0179

Country

Georgia

Facility Name

Teva Investigational Site 3268

City

Bad Wildbad

ZIP/Postal Code

75323

Country

Germany

Facility Name

Teva Investigational Site 3272

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Teva Investigational Site 3262

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Teva Investigational Site 3276

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Teva Investigational Site 3271

City

Bonn

ZIP/Postal Code

53117

Country

Germany

Facility Name

Teva Investigational Site 3265

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Teva Investigational Site 3267

City

Duesseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Teva Investigational Site 3263

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Teva Investigational Site 3269

City

Hamburg

ZIP/Postal Code

22179

Country

Germany

Facility Name

Teva Investigational Site 3266

City

Hannover

ZIP/Postal Code

30171

Country

Germany

Facility Name

Teva Investigational Site 3270

City

Herborn

ZIP/Postal Code

35745

Country

Germany

Facility Name

Teva Investigational Site 3273

City

Kaltenkirchen

ZIP/Postal Code

24568

Country

Germany

Facility Name

Teva Investigational Site 3275

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Teva Investigational Site 3261

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Teva Investigational Site 3264

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Teva Investigational Site 5127

City

Budapest

ZIP/Postal Code

H-1115

Country

Hungary

Facility Name

Teva Investigational Site 5129

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Teva Investigational Site 5130

City

Eger

ZIP/Postal Code

H-3300

Country

Hungary

Facility Name

Teva Investigational Site 5132

City

Esztergom

ZIP/Postal Code

H-2500

Country

Hungary

Facility Name

Teva Investigational Site 5131

City

Gyor

ZIP/Postal Code

H-9023

Country

Hungary

Facility Name

Teva Investigational Site 5128

City

Kaposvar

ZIP/Postal Code

H-7400

Country

Hungary

Facility Name

Teva Investigational Site 5133

City

Veszprem

ZIP/Postal Code

H-8200

Country

Hungary

Facility Name

Teva Investigational Site 8052

City

Ramat Gan

ZIP/Postal Code

5262160

Country

Israel

Facility Name

Teva Investigational Site 3089

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

Teva Investigational Site 3084

City

Cefalu

ZIP/Postal Code

90015

Country

Italy

Facility Name

Teva Investigational Site 3092

City

Cosenza

ZIP/Postal Code

87100

Country

Italy

Facility Name

Teva Investigational Site 3080

City

Milano

ZIP/Postal Code

20148

Country

Italy

Facility Name

Teva Investigational Site 3086

City

Rome

ZIP/Postal Code

00144

Country

Italy

Facility Name

Teva Investigational Site 5710

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Teva Investigational Site 5712

City

Siauliai

ZIP/Postal Code

76231

Country

Lithuania

Facility Name

Teva Investigational Site 5711

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Teva Investigational Site 5374

City

Czestochowa

ZIP/Postal Code

42-200

Country

Poland

Facility Name

Teva Investigational Site 5377

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Teva Investigational Site 5381

City

Gdansk

ZIP/Postal Code

80-299

Country

Poland

Facility Name

Teva Investigational Site 5380

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Teva Investigational Site 5376

City

Gorzow Wielkopolski

ZIP/Postal Code

66-400

Country

Poland

Facility Name

Teva Investigational Site 5372

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Teva Investigational Site 5375

City

Katowice

ZIP/Postal Code

40-684

Country

Poland

Facility Name

Teva Investigational Site 5368

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Teva Investigational Site 5379

City

Kielce

ZIP/Postal Code

25-726

Country

Poland

Facility Name

Teva Investigational Site 5382

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Teva Investigational Site 5369

City

Koscierzyna

ZIP/Postal Code

83-400

Country

Poland

Facility Name

Teva Investigational Site 5378

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

Teva Investigational Site 5366

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 5373

City

Olsztyn

ZIP/Postal Code

10-560

Country

Poland

Facility Name

Teva Investigational Site 5384

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Teva Investigational Site 5371

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Teva Investigational Site 5367

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Teva Investigational Site 5370

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Teva Investigational Site 5233

City

Balotesti

ZIP/Postal Code

077015

Country

Romania

Facility Name

Teva Investigational Site 5222

City

Bucharest

ZIP/Postal Code

010825

Country

Romania

Facility Name

Teva Investigational Site 5221

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Teva Investigational Site 5220

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

Teva Investigational Site 5227

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Teva Investigational Site 5230

City

Cluj-Napoca

ZIP/Postal Code

400437

Country

Romania

Facility Name

Teva Investigational Site 5225

City

Constanta

ZIP/Postal Code

900123

Country

Romania

Facility Name

Teva Investigational Site 5226

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Teva Investigational Site 5232

City

Craiova

ZIP/Postal Code

200515

Country

Romania

Facility Name

Teva Investigational Site 5231

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Teva Investigational Site 5223

City

Piatra-Neamt

ZIP/Postal Code

610136

Country

Romania

Facility Name

Teva Investigational Site 5228

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

Teva Investigational Site 5229

City

Targu-Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Teva Investigational Site 5224

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Teva Investigational Site 5063

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Teva Investigational Site 5059

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Teva Investigational Site 5068

City

Irkutsk

ZIP/Postal Code

664079

Country

Russian Federation

Facility Name

Teva Investigational Site 5067

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Teva Investigational Site 5052

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Teva Investigational Site 5057

City

Nizhny Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Teva Investigational Site 5062

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

Teva Investigational Site 5060

City

Perm

ZIP/Postal Code

614990

Country

Russian Federation

Facility Name

Teva Investigational Site 5053

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Teva Investigational Site 5058

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Teva Investigational Site 5064

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Teva Investigational Site 5056

City

St. Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Teva Investigational Site 5055

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Teva Investigational Site 5054

City

St. Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Teva Investigational Site 5066

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Teva Investigational Site 5061

City

Ufa

ZIP/Postal Code

450007

Country

Russian Federation

Facility Name

Teva Investigational Site 5065

City

Yaroslavl

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Teva Investigational Site 9020

City

Johannesburg

ZIP/Postal Code

2157

Country

South Africa

Facility Name

Teva Investigational Site 9019

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Teva Investigational Site 9022

City

Pietermaritzburg

ZIP/Postal Code

3201

Country

South Africa

Facility Name

Teva Investigational Site 9025

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Teva Investigational Site 9018

City

Pretoria

ZIP/Postal Code

0041

Country

South Africa

Facility Name

Teva Investigational Site 9021

City

Rosebank

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Teva Investigational Site 9024

City

Umhlanga

ZIP/Postal Code

4320

Country

South Africa

Facility Name

Teva Investigational Site 5835

City

Chernihiv

ZIP/Postal Code

14029

Country

Ukraine

Facility Name

Teva Investigational Site 5834

City

Chernivtsi

ZIP/Postal Code

58018

Country

Ukraine

Facility Name

Teva Investigational Site 5827

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Teva Investigational Site 5828

City

Donetsk

ZIP/Postal Code

83003

Country

Ukraine

Facility Name

Teva Investigational Site 5829

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Teva Investigational Site 5830

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

Teva Investigational Site 5833

City

Kyiv

ZIP/Postal Code

03110

Country

Ukraine

Facility Name

Teva Investigational Site 5836

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Teva Investigational Site 5825

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Teva Investigational Site 5839

City

Odesa

ZIP/Postal Code

65014

Country

Ukraine

Facility Name

Teva Investigational Site 5832

City

Poltava

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

Teva Investigational Site 5838

City

Simferopol

ZIP/Postal Code

295017

Country

Ukraine

Facility Name

Teva Investigational Site 5837

City

Uzhgorod

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

Teva Investigational Site 5826

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Teva Investigational Site 5831

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Teva Investigational Site 3439

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Teva Investigational Site 3438

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Teva Investigational Site 3440

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27503905

Citation

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.

Results Reference

derived

Learn more about this trial

We'll reach out to this number within 24 hrs

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)

Relapsing Remitting Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial