Summary: Investigators are recruiting approximately 550 people with relapsing-remitting MS worldwide for a study to determine the effectiveness, safety and tolerability of four doses of plovamer acetate versus Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries, Ltd.). The study is funded by EMD Serono.
Rationale: Plovamer acetate is a drug delivered once weekly subcutaneously (under the skin). Like Copaxone, it is a copolymer, a compound that is synthesized by linking single amino acids (molecules used to build proteins) in random order to chains of multiple amino acids. Such chains are also called polypeptides. Plovamer acetate is an immunomodulator. It is believed to reduce the immune attack on the brain and spinal cord of people with MS but not to reduce the immune response against infections. Plovamer acetate was tested in two Phase 1 studies. (The Journal of Neuroimmunology 2010;225:153)
Eligibility and Details: People between the ages of 18 and 60 are eligible for this study. Patients must have had a diagnosis of relapsing-remitting MS. Further details on enrollment criteria are available from the contact below.
Participants will be randomly assigned to one of five groups. They will receive either plovamer acetate (0.5 mg, 3 mg, 10 mg, or 20 mg, once per week injected under the skin), or Copaxone 20 mg once per day injected under the skin. Study participants will receive treatment for at least 40 weeks.
The primary goal of the study is to determine the effect on disease activity observed on MRI scans. Other outcomes being studied are relapse rate, EDSS and MSFC (scales used to measure MS disease activity), and fatigue.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email Marc Gleichmann (firstname.lastname@example.org) or Colleen Ferris (Colleen.email@example.com), or call EMD Serono US Medical Information at 1-866-275-7376.
Sites are currently enrolling in the following cities:
San Diego, CA
Pompano Beach, FL
Round Rock, TX
San Antonio, TX
Please contact EMD Serono for the most up-to-date list of enrolling sites.