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Safety and Tolerability of Glatiramer Acetate (GLACIER)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

GA 20 mg/mL

GA 40 mg/mL

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women at least 18 years of age or older
Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course
Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5 in both the Screening and Baseline visits.
Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
Subjects must be treated with Glatiramer Acetate (GA) 20mg/mL QD SC injection for a minimum of 6 months prior to screening.
Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)].
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:

Subject has any contraindication to Glatiramer Acetate therapy
Subjects with progressive forms of multiple sclerosis (MS).
Subjects with Neuromyelitis Optica (NMO).
Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
Concomitant use of other disease modifying drug for MS ((Fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG)) within 6 months prior to screening
Previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab.
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 and abnormal laboratory tests. 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.
Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals -

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GA 20 mg/mL every day

GA 40 mg/mL 3 times a week

Arm Description

Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study.

Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core study. During the Extension period, all participants to continue treatment with GA 40 mg/mL TIW until this dose regimen is commercially available for the treatment of RRMS patients.

Outcomes

Primary Outcome Measures

Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period

Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient. Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group.

Injection-Related Adverse Event Rate Per Year in the Extension Period

Injection-Related Adverse Events in the Extension Period

Secondary Outcome Measures

Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period

This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years. For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient. Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group.

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing over time. The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 physical score, treatment group, month, treatment by month interaction.

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing over time. The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 psychological score, treatment group, month, treatment by month interaction.

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) - 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement. The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction.

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication. The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction.

Injection Site Reaction Event Rate Per Year in the Extension Period

Injection Site Reaction Events in the Extension Period

This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient.

Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)

The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)

The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) - 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Full Information

NCT ID

NCT01874145

First Posted

June 6, 2013

Last Updated

December 10, 2015

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01874145

Brief Title

Safety and Tolerability of Glatiramer Acetate

Acronym

GLACIER

Official Title

An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.

Detailed Description

The study will comprise of a Core study and an Extension phase. During the Core study, subjects will be evaluated at study sites for 5 scheduled visits at Months: -1 (Screening), 0 (Baseline), 1, 2, and 4 (Termination/Early Termination). Subjects who complete all scheduled visits will have final procedures and assessments performed at the final visit (Month 4, Termination visit). Subjects who withdraw from the study before completing the 4 months evaluation period will have Early Termination (ET) procedures and assessments performed at their final visit. During the Extension phase, all subjects will be offered to continue treatment with GA 40 mg/mL TIW. Subjects will be evaluated every 4 months 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, the last visit of this phase will be called Termination/ET-Extension visit.

6. Conditions and Keywords

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

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Glatiramer Acetate, Glatiramer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GA 20 mg/mL every day

Arm Type

Active Comparator

Arm Description

Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study.

Arm Title

GA 40 mg/mL 3 times a week

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

GA 20 mg/mL

Other Intervention Name(s)

Glatiramer Acetate, Copaxone®

Intervention Description

Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Intervention Type

Drug

Intervention Name(s)

GA 40 mg/mL

Other Intervention Name(s)

Glatiramer Acetate, Copaxone®

Intervention Description

Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Primary Outcome Measure Information:

Title

Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period

Description

Time Frame

Day 1 to Month 4

Title

Injection-Related Adverse Event Rate Per Year in the Extension Period

Description

Time Frame

Month 5 up to Month 10

Title

Injection-Related Adverse Events in the Extension Period

Description

Time Frame

Month 5 up to Month 10

Secondary Outcome Measure Information:

Title

Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period

Description

Time Frame

Day 1 to Month 4

Title

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

Description

Time Frame

Month 0 (baseline), Months 1, 2, 4 (or early termination visit)

Title

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

Description

Time Frame

Month 0 (baseline), Months 1, 2 4 (or early termination visit)

Title

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period

Description

Time Frame

Month 0 (baseline), Months 1, 2 4 (or early termination visit)

Title

Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period

Description

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication. The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction.

Time Frame

Month 0 (baseline), Months 1, 2 4 (or early termination visit)

Title

Injection Site Reaction Event Rate Per Year in the Extension Period

Description

Time Frame

Month 5 up to Month 10

Title

Injection Site Reaction Events in the Extension Period

Description

Time Frame

Month 5 up to Month 10

Title

Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)

Description

The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Time Frame

Month 4 (baseline for extension period), Month 8, endpoint visit

Title

Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)

Description

The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Time Frame

Month 4 (baseline for extension period), Month 8, endpoint visit

Title

Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score

Description

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) - 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Time Frame

Month 4 (baseline for extension period), Month 8, endpoint visit

Title

Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score

Description

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication. The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period.

Time Frame

Month 4 (baseline for extension period), Month 8, endpoint visit

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period

Description

An adverse event was defined in the protocol as any untoward medical occurrence in a patient that developed or worsened in severity during the conduct of the clinical study of a pharmaceutical product and did not necessarily have a causal relationship to the study drug. This outcome summarizes the % of participants who had AEs other than injection related reactions. Injection-related (IR) adverse events referring to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).

Time Frame

Day 1 to Month 4 (core period); Month 5 to 10 (extension period)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women at least 18 years of age or older Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5 in both the Screening and Baseline visits. Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization. Subjects must be treated with Glatiramer Acetate (GA) 20mg/mL QD SC injection for a minimum of 6 months prior to screening. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)]. 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: Subject has any contraindication to Glatiramer Acetate therapy Subjects with progressive forms of multiple sclerosis (MS). Subjects with Neuromyelitis Optica (NMO). Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. Concomitant use of other disease modifying drug for MS ((Fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG)) within 6 months prior to screening Previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab. 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 and abnormal laboratory tests. 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. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI). Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals -

Facility Information:

Facility Name

Teva Investigational Site 10706

City

Cullman

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10719

City

Gilbert

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 10720

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 10727

City

Fresno

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10731

City

Long Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10735

City

Newport Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10712

City

Oceanside

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10708

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10715

City

Maitland

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10718

City

Pompano Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10709

City

St. Petersburg

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10707

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10711

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10710

City

Northbrook

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 10734

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10732

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10726

City

Great Falls

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 10702

City

Henderson

State/Province

Nevada

Country

United States

Facility Name

Teva Investigational Site 10717

City

Patchogue

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10723

City

Plainview

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10716

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10724

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10721

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10733

City

Bellevue

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10703

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10714

City

Dayton

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10704

City

Uniontown

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10725

City

East Providence

State/Province

Rhode Island

Country

United States

Facility Name

Teva Investigational Site 10736

City

Cordova

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 10701

City

Franklin

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 10728

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 10729

City

Mansfield

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10722

City

Round Rock

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10699

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

Teva Investigational Site 10700

City

Roanoke

State/Province

Virginia

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26195058

Citation

Wolinsky JS, Borresen TE, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S; GLACIER Study Group. GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40 mg three-times weekly versus 20 mg daily in patients with relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):370-6. doi: 10.1016/j.msard.2015.06.005. Epub 2015 Jun 14.

Results Reference

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Safety and Tolerability of Glatiramer Acetate

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Safety and Tolerability of Glatiramer Acetate (GLACIER)

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