EUCTR2009-018084-27-DEActive, not recruitingPhase 1
A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA
Teva Pharmaceutical Industries, Ltd.0 sites1,350 target enrollmentStarted: March 9, 2010Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], 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 [intravenous (IV), intramuscular (IM) and/or per os (PO)] or ACTH (Adrenocorticotropic hormone) 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 [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)].
- •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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1350
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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 agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening.
- •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 [including IFNß 1a and 1b, and IV Immunoglobulin (IVIg)] within 2 months prior to screening.
- •7. Previous use of GA or any other glatiramoid.
- •8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) 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. Inability to successfully undergo MRI scanning.
- •15. A known drug hypersensitivity to Mannitol.
- •16. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Investigators
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