Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Glatiramer Acetate

Criteria

Inclusion Criteria:

• Male or female, between the ages of 18 and 60 years

• Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)

• Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing

• Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI

• 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)

• Contraindication to Copaxone use

• Other protocol defined exclusion criteria could apply