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Relapsing-Remitting Multiple SclerosisPhase 3GLOWNCT01578785

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

A Phase 3 study testing Glatiramer Acetate in people with Relapsing-Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 169 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
169 sitesin 19 countries
Study dates
Mar 2012to Nov 2012
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 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,
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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).

Trial locations and contacts

169 sites in 19 countries.

169 sites in 19 countries

United States25 sites

  • Teva Investigational Site 10194

    Akron, Ohio

  • Teva Investigational Site 10196

    Centennial, Colorado

  • Teva Investigational Site 10198

    Charlotte, North Carolina

  • Teva Investigational Site 10181

    Chicago, Illinois

  • Teva Investigational Site 10206

    Cordova, Tennessee

  • Teva Investigational Site 10214

    Cordova, Tennessee

  • Teva Investigational Site 10192

    Cullman, Alabama

  • Teva Investigational Site 10191

    Dayton, Ohio

  • Teva Investigational Site 10204

    Fresno, California

  • Teva Investigational Site 10203

    Hickory, North Carolina

  • Teva Investigational Site 10209

    Hickory, North Carolina

  • Teva Investigational Site 10201

    La Jolla, California

  • Teva Investigational Site 10184

    Miami, Florida

  • Teva Investigational Site 10186

    Nashville, Tennessee

  • Teva Investigational Site 10202

    Northbrook, Illinois

  • Teva Investigational Site 10188

    Patchogue, New York

  • Teva Investigational Site 10212

    Raleigh, North Carolina

  • Teva Investigational Site 10180

    Sarasota, Florida

  • Teva Investigational Site 10197

    Sarasota, Florida

  • Teva Investigational Site 10190

    Tampa, Florida

  • Teva Investigational Site 10207

    Tampa, Florida

  • Teva Investigational Site 10200

    Uniontown, Ohio

  • Teva Investigational Site 10199

    Vero Beach, Florida

  • Teva Investigational Site 10213

    Winston-Salem, North Carolina

  • Teva Investigational Site 10215

    Winston-Salem, North Carolina

Other trials in United States

Bulgaria23 sites

  • Teva Investigational Site 59020

    Blagoevgrad

  • Teva Investigational Site 59018

    Pleven

  • Teva Investigational Site 59019

    Pleven

  • Teva Investigational Site 59025

    Pleven

  • Teva Investigational Site 59024

    Rousse

  • Teva Investigational Site 59023

    Shumen

  • Teva Investigational Site 59006

    Sofia

  • Teva Investigational Site 59007

    Sofia

  • Teva Investigational Site 59008

    Sofia

  • Teva Investigational Site 59009

    Sofia

  • Teva Investigational Site 59010

    Sofia

  • Teva Investigational Site 59011

    Sofia

  • Teva Investigational Site 59012

    Sofia

  • Teva Investigational Site 59014

    Sofia

  • Teva Investigational Site 59015

    Sofia

  • Teva Investigational Site 59016

    Sofia

  • Teva Investigational Site 59017

    Sofia

  • Teva Investigational Site 59021

    Sofia

  • Teva Investigational Site 59026

    Sofia

  • Teva Investigational Site 59022

    Stara Zagora

  • Teva Investigational Site 59013

    Varna

  • Teva Investigational Site 59027

    Veliko Tarnovo

  • Teva Investigational Site 59028

    Veliko Tarnovo

Other trials in Bulgaria

Russia23 sites

  • Teva Investigational Site 50023

    Barnaul

  • Teva Investigational Site 50021

    Chelyabinsk

  • Teva Investigational Site 50025

    Kazan'

  • Teva Investigational Site 50039

    Krasnodar

  • Teva Investigational Site 50022

    Moscow

  • Teva Investigational Site 50034

    Moscow

  • Teva Investigational Site 50035

    Moscow

  • Teva Investigational Site 50036

    Moscow

  • Teva Investigational Site 50020

    Nizhny Novgorod

  • Teva Investigational Site 50024

    Nizhny Novgorod

  • Teva Investigational Site 50123

    Nizhny Novgorod

  • Teva Investigational Site 50027

    Novosibirsk

  • Teva Investigational Site 50019

    Perm

  • Teva Investigational Site 50038

    Rostov-on-Don

  • Teva Investigational Site 50029

    Saint Petersburg

  • Teva Investigational Site 50032

    Saint Petersburg

  • Teva Investigational Site 50030

    Samara

  • Teva Investigational Site 50037

    Saratov

  • Teva Investigational Site 50028

    Smolensk

  • Teva Investigational Site 50031

    Tyumen

  • Teva Investigational Site 50026

    Ufa

  • Teva Investigational Site 50040

    Volgograd

  • Teva Investigational Site 50033

    Yaroslavl

Other trials in Russia

Poland19 sites

  • Teva Investigational Site 53033

    Bialystok

  • Teva Investigational Site 53020

    Częstochowa

  • Teva Investigational Site 53023

    Gdansk

  • Teva Investigational Site 53024

    Gdansk

  • Teva Investigational Site 53031

    Grodzisk Mazowiecki

  • Teva Investigational Site 53032

    Grodzisk Mazowiecki

  • Teva Investigational Site 53021

    Katowice

  • Teva Investigational Site 53019

    Kielce

  • Teva Investigational Site 53028

    Konstancin-Jeziorna

  • Teva Investigational Site 53037

    Kościerzyna

  • Teva Investigational Site 53018

    Lodz

  • Teva Investigational Site 53027

    Lublin

  • Teva Investigational Site 53036

    Olsztyn

  • Teva Investigational Site 53034

    Poznan

  • Teva Investigational Site 53030

    Poznan / Plewiska

  • Teva Investigational Site 53025

    Szczecin

  • Teva Investigational Site 53026

    Szczecin

  • Teva Investigational Site 53022

    Warsaw

  • Teva Investigational Site 53029

    Warsaw

Other trials in Poland

Ukraine14 sites

  • Teva Investigational Site 58022

    Chernihiv

  • Teva Investigational Site 58030

    Donetsk

  • Teva Investigational Site 58020

    Ivano-Frankivsk

  • Teva Investigational Site 58028

    Kharkiv

  • Teva Investigational Site 58023

    Kyiv

  • Teva Investigational Site 58025

    Kyiv

  • Teva Investigational Site 58018

    Lviv

  • Teva Investigational Site 58021

    Odesa

  • Teva Investigational Site 58029

    Poltava

  • Teva Investigational Site 58032

    Simferopol, AR Crimea

  • Teva Investigational Site 58031

    Uzhhorod

  • Teva Investigational Site 58027

    Vinnytsia

  • Teva Investigational Site 58019

    Zaporizhzhya

  • Teva Investigational Site 58024

    Zaporizhzhya

Other trials in Ukraine

Romania12 sites

  • Teva Investigational Site 52010

    Bucharest

  • Teva Investigational Site 52012

    Bucharest

  • Teva Investigational Site 52015

    Cluj-Napoca

  • Teva Investigational Site 52016

    Cluj-Napoca

  • Teva Investigational Site 52017

    Constanța

  • Teva Investigational Site 52018

    Constanța

  • Teva Investigational Site 52014

    Iași

  • Teva Investigational Site 52021

    Oradea

  • Teva Investigational Site 52011

    Piatra Neamţ

  • Teva Investigational Site 52013

    Sibiu

  • Teva Investigational Site 52020

    Târgu Mureş

  • Teva Investigational Site 52019

    Timișoara

Other trials in Romania

Belarus7 sites

  • Teva Investigational Site 68004

    Grodno

  • Teva Investigational Site 68007

    Homyel

  • Teva Investigational Site 68003

    Minsk

  • Teva Investigational Site 68005

    Minsk

  • Teva Investigational Site 68006

    Minsk

  • Teva Investigational Site 68001

    Vitebsk

  • Teva Investigational Site 68002

    Vitebsk

Other trials in Belarus

Croatia7 sites

  • Teva Investigational Site 60003

    Osijek

  • Teva Investigational Site 60005

    Varaždin

  • Teva Investigational Site 60001

    Zagreb

  • Teva Investigational Site 60002

    Zagreb

  • Teva Investigational Site 60004

    Zagreb

  • Teva Investigational Site 60006

    Zagreb

  • Teva Investigational Site 60007

    Zagreb

Other trials in Croatia

Mexico6 sites

  • Teva Investigational Site 21023

    Estado de México

  • Teva Investigational Site 21021

    Guadalajara, Jalisco

  • Teva Investigational Site 21022

    Mexico City, Distrito Federal

  • Teva Investigational Site 21025

    Monterrey

  • Teva Investigational Site 21020

    Morelia, Michoacan

  • Teva Investigational Site 21024

    San Luís Potosí

Other trials in Mexico

North Macedonia6 sites

  • Teva Investigational Site 65005

    Shtip

  • Teva Investigational Site 65001

    Skopje

  • Teva Investigational Site 65002

    Skopje

  • Teva Investigational Site 65003

    Skopje

  • Teva Investigational Site 65006

    Strumica

  • Teva Investigational Site 65004

    Tetovo

Other trials in North Macedonia

Georgia5 sites

  • Teva Investigational Site 81001

    Tbilisi

  • Teva Investigational Site 81002

    Tbilisi

  • Teva Investigational Site 81003

    Tbilisi

  • Teva Investigational Site 81004

    Tbilisi

  • Teva Investigational Site 81005

    Tbilisi

Other trials in Georgia

Greece5 sites

  • Teva Investigational Site 63017

    Athens

  • Teva Investigational Site 63021

    Athens

  • Teva Investigational Site 63020

    Melíssia

  • Teva Investigational Site 63018

    Thessaloniki

  • Teva Investigational Site 63019

    Thessaloniki

Other trials in Greece

Bosnia and Herzegovina4 sites

  • Teva Investigational Site 69004

    Bihać

  • Teva Investigational Site 69002

    Mostar

  • Teva Investigational Site 69001

    Sarajevo

  • Teva Investigational Site 69003

    Tuzla

Other trials in Bosnia and Herzegovina

Moldova4 sites

  • Teva Investigational Site 70001

    Chisinau

  • Teva Investigational Site 70002

    Chisinau

  • Teva Investigational Site 70003

    Chisinau

  • Teva Investigational Site 70004

    Chisinau

Other trials in Moldova

Serbia4 sites

  • Teva Investigational Site 61002

    Belgrade

  • Teva Investigational Site 61005

    Belgrade

  • Teva Investigational Site 61001

    Kragujevac

  • Teva Investigational Site 61003

    Niš

Other trials in Serbia

Estonia2 sites

  • Teva Investigational Site 55004

    Pärnu

  • Teva Investigational Site 55003

    Tallinn

Other trials in Estonia

Albania1 site

  • Teva Investigational Site 67001

    Tirana

Other trials in Albania

Latvia1 site

  • Teva Investigational Site 56004

    Riga

Other trials in Latvia

Montenegro1 site

  • Teva Investigational Site 66001

    Podgorica

Other trials in Montenegro

About this study

Official title: A 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

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Read the detailed description

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

Being tested
Glatiramer Acetate, Placebo
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 AcetateDrug

    Also called Copaxone®

    Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.

  • PlaceboDrug

    Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Study groups in NCT01578785
Study groupRoleWhat they receive
Glatiramer AcetateExperimentalGlatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Receives: Drug: Glatiramer Acetate
PlaceboPlacebo comparatorPlacebo solution in prefilled syringe for subcutaneous injection once daily.
Receives: Drug: Placebo

What is being measured

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

  1. The Annualized Relapse Rate During the Placebo Controlled Period

    The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.

    Measured: Day 1 up to Month 12

Secondary outcomes (3)

  1. The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)

    Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.

    Measured: Day 1 up to Month 12

  2. The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)

    Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.

    Measured: Day 1 up to Month 12

  3. Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume

    Brain atrophy was defined by the percent brain volume change from baseline to Month 12

    Measured: Day 1 up to Month 12

Timeline

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

  1. First posted17 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2012
  4. Study completionNov 2012

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
Double blind
Who is masked
Participant, Investigator
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578785
Sponsor's protocol ID
GA-MS-302
Other IDs
2011-005550-57
Acronym
GLOW
Status last verified
Feb 2014
First submitted
13 Mar 2012
Last updated
2 Apr 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glatiramer Acetate in people with Relapsing-Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 169 sites in 19 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 12 inclusion and 18 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: stopped early, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Bulgaria, Russia, Poland, Ukraine and 14 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 2 Apr 2014). 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?

The Annualized Relapse Rate During the Placebo Controlled Period (time frame: Day 1 up to Month 12). 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 NCT01578785.

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 2 Apr 2014.

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