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)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT01578785

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

178

Starts

2012-03-01

Expected to finish

2012-11-01

Last updated by the study team

2014-04-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Teva Investigational Site 10204 — Fresno, California, United States
• Teva Investigational Site 10201 — La Jolla, California, United States
• Teva Investigational Site 10196 — Centennial, Colorado, United States
• Teva Investigational Site 10184 — Miami, Florida, United States
• Teva Investigational Site 10180 — Sarasota, Florida, United States
• Teva Investigational Site 10197 — Sarasota, Florida, United States
• Teva Investigational Site 10190 — Tampa, Florida, United States
• Teva Investigational Site 10207 — Tampa, Florida, United States
• Teva Investigational Site 10199 — Vero Beach, Florida, United States
• Teva Investigational Site 10181 — Chicago, Illinois, United States
• Teva Investigational Site 10202 — Northbrook, Illinois, United States
• Teva Investigational Site 10188 — Patchogue, New York, United States
• Teva Investigational Site 10198 — Charlotte, North Carolina, United States
• Teva Investigational Site 10203 — Hickory, North Carolina, United States
• Teva Investigational Site 10209 — Hickory, North Carolina, United States
• Teva Investigational Site 10212 — Raleigh, North Carolina, United States
• Teva Investigational Site 10213 — Winston-Salem, North Carolina, United States
• Teva Investigational Site 10215 — Winston-Salem, North Carolina, United States
• Teva Investigational Site 10194 — Akron, Ohio, United States
• Teva Investigational Site 10191 — Dayton, Ohio, United States
• Teva Investigational Site 10200 — Uniontown, Ohio, United States
• Teva Investigational Site 10206 — Cordova, Tennessee, United States
• Teva Investigational Site 10214 — Cordova, Tennessee, United States
• Teva Investigational Site 10186 — Nashville, Tennessee, United States
• Teva Investigational Site 10192 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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