Mobile

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...

Update Il y a 4 ans
Reference: EUCTR2013-002283-25

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

Woman and Man

  • | Country :
    • -
  • | organs :
    • -
  • | Specialty :
    • -

Extract

The primary objective of this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS.

Inclusion criteria

  • Male and female patients between the ages of 18 and 60 years with a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria)

Links