A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).

TEVA Pharmaceutical Industries Ltd.0 个研究点目标入组 25 人开始时间: 2004年7月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Clinically Definite Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983;13:227-231)
•2. Subjects must have had at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans
•3. Subjects must be of the relapsing-remitting (R-R) type (Neurol 1996;46:907-911)
•4. Subjects must have had at least one documented relapse within one year prior to screening visit (week -10)
•5. Subjects must be relapse-free for at least 30 days prior to screening visit (week -10)
•6. Subjects must not have taken corticosteroids (intravenous, intramuscular and/or per os) for at least 30 days prior to screening visit (week -10)
•7. Women of childbearing potential must practice an acceptable method of birth control
•8. Subjects must be between the ages of 18 and 50 years inclusive
•9. Subjects must be ambulatory, with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5 inclusive
•10. Subjects must be willing and able to give signed written informed consent prior to entering 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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnancy or lactation
•2. Previous use of any formulation of Glatiramer Acetate
•3. Use of cladribine within 2 years prior to screening visit (week -10)
•4. Use of immunosuppressive (including mitoxantrone) or immunomodulating treatments within 6 months prior to screening visit (except for interferon agents)
•5. Use of interferon agents within 60 days prior to screening visit
•6. Chronic (more than 30 consecutive days) corticosteroid treatment (iv, im and/or po) within 6 months prior to screening visit
•7. Use of experimental drugs within 6 months prior to screening visit (week -10)
•8. Subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, gastrointestinal, renal or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest X-ray or ECG
•9. Any medical or psychiatric conditions that affect the subject's ability to give informed consent or to complete the study, or if the subject is considered by the treating neurologist to be, for any other reason, an unsuitable candidate for this study
•10. Subject's inability to undergo successful MRI scans
•11. Known sensitivity to Gd

发起方