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)

Conditions: Relapsing-Remitting Multiple Sclerosis

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).

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

Eligibility 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).