Relapsing-remitting multiple sclerosis (R-R MS) MedDRA version: 5.1 Level: PT Classification code 10028245
Conditions
Interventions
Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Glatiramer Acetate
CAS Number: 147245-92-9
Current Sponsor code
Sponsors
TEVA Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of a daily oral dose of 600 mg glatiramer acetate on MRI disease activity as measured by the total number of T1 gadolinium-enhancing lesions in subjects with relapsing-remitting multiple sclerosis.;Secondary Objective: To evaluate the effect of a daily oral dose of 600 mg glatiramer acetate on the total number of new T2 lesions.;Primary end point(s): Primary efficacy endpoint: Change in the sum of T1 Gd-enhancing lesions from pre-treatment (weeks -10 [screening], -6 and 0 [baseline]) to the last study trimester (weeks 28, 32 and 36 [termination]). | — |
Countries
Hungary, Italy
Outcome results
None listed