A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).
- Conditions
- Relapsing-remitting Multiple sclerosis (RRMS)MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-005550-57-GR
- Lead Sponsor
- Teva Pharmaceutical Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1400
1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with a relapsing-remitting disease course.
2.Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
3.Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment or ACTH, 30 days prior to screening (Month -1) and between screening and baseline (Month 0) visits.
4.Subjects must have experienced one of the following:
•At least one documented relapse in the 12 months prior to screening, or
•At least two documented relapses in the 24 months prior to screening, or
•One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
5.Subjects must be between 18 and 55 years of age, inclusive.
6.Women of child-bearing potential must practice an acceptable method of birth control.
7.Subjects must be able to sign and date a written informed consent prior to entering the study.
8.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Subjects with progressive forms of MS.
2.Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
3.Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
4.Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
5.Use of cladribine within 2 years prior to screening.
6.Previous treatment with immunomodulators within 2 months prior to screening.
7.Previous use of GA or any other glatiramoid.
8.Chronic systemic corticosteroid treatment within 6 months prior to screening visit.
9.Previous total body irradiation or total lymphoid irradiation.
10.Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
11.Pregnancy or breastfeeding.
12.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.
13.A known history of sensitivity to Gadolinium.
14.GFR = 60 mL/min/ 1.73m2 at the screening visit
15.Inability to successfully undergo MRI scanning.
16.A known drug hypersensitivity to Mannitol.
17.Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method