Suspended

GLOWA Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Glatiramer Acetate

+ Placebo

Drug
Who is being recruted

Autoimmune Diseases+5

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Official TitleA Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection
NCT01578785
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

178 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMultiple Sclerosis, Relapsing-Remitting

Criteria

Inclusion Criteria: Subjects must meet all inclusion criteria in order to be eligible for the study: * Subjects must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course. * Subjects must be ambulatory with a Kurtzke's Expanded Disability Status Scale (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 \[intravenous (IV), intramuscular (IM) and/or by mouth (PO)\] or ACTH (adrenocorticotropic hormone) 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, * At least two documented relapses in the 24 months prior to screening, * One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in a magnetic resonance imaging (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 \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)\]. * 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: Any of the following conditions will exclude the subject from entering the study: * 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 agents (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 glatiramer acetate (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. * Glomerular filtration rate (GFR) ≤ 60 mL/minute at the screening visit * Inability to successfully undergo MRI scanning. * A known drug hypersensitivity to Mannitol. * Subjects who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.

Group II

Placebo
Placebo solution in prefilled syringe for subcutaneous injection once daily.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 169 locations

Suspended

Teva Investigational Site 68007

Homyel, BelarusOpen Teva Investigational Site 68007 in Google Maps
Suspended

Teva Investigational Site 68003

Minsk, Belarus
Suspended

Teva Investigational Site 68005

Minsk, Belarus
Suspended

Teva Investigational Site 68006

Minsk, Belarus
Suspended169 Study Centers