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

Stopped early · Phase 2

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01963611

Run by

EMD Serono

People needed

255

Starts

2013-10-01

Expected to finish

2015-03-01

Last updated by the study team

2016-05-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research site — San Diego, California, United States
• Research site — San Diego, California, United States
• Research site — Fairfield, Connecticut, United States
• Research site — Dover, Delaware, United States
• Research site — Miami, Florida, United States
• Research site — Naples, Florida, United States
• Research site — Pompano Beach, Florida, United States
• Research site — Sarasota, Florida, United States
• Research site — Sunrise, Florida, United States
• Research site — Columbus, Georgia, United States
• Research site — Rome, Georgia, United States
• Research site — Elk Grove Village, Illinois, United States
• Research site — Indianapolis, Indiana, United States
• Research site — Baltimore, Maryland, United States
• Research site — New Bedford, Massachusetts, United States
• Research site — Worcester, Massachusetts, United States
• Research site — Detroit, Michigan, United States
• Research Site — Detroit, Michigan, United States
• Research site — Golden Valley, Minnesota, United States
• Research site — St Louis, Missouri, United States
• Research site — Plainview, New York, United States
• Research site — Charlotte, North Carolina, United States
• Research site — Hickory, North Carolina, United States
• Research site — Matthews, North Carolina, United States
• Research site — Redding, California, United States

Full record on ClinicalTrials.gov

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