A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate

Merck KGaA0 个研究点目标入组 550 人开始时间: 2013年12月4日最近更新: 2016年1月4日

试验速览

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•1. Male or female, between the ages of 18 and 60 years.
•2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
•3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).
•Other protocol defined inclusion criteria could apply
•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 550
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
•1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
•2. Any relapse of MS within 30 days of the Baseline Visit 2.
•3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
•4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed.)
•5. Contraindication to Copaxone use.
•Other protocol defined exclusion criteria could apply

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