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



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:October 2013
End Date:March 2015

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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

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.


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
We found this trial at
34
sites
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
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344
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Baltimore, MD
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Blagoevgrad,
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98
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Cincinnati, OH
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529
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Columbus, GA
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64
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from 43215
Dayton, OH
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163
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Detroit, MI
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403
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Dover, DE
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Elk Grove Village, Illinois 60007
295
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Elk Grove Village, IL
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519
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from 43215
Fairfield, CT
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630
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from 43215
Golden Valley, MN
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304
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from 43215
Hickory, NC
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166
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from 43215
Indianapolis, IN
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357
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from 43215
Matthews, NC
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993
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from 43215
Miami, FL
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957
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from 43215
Naples, FL
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331
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from 43215
Nashville, TN
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New Bedford, Massachusetts 02740
642
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New Bedford, MA
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505
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from 43215
Plainview, NY
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963
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from 43215
Pompano Beach, FL
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371
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from 43215
Raleigh, NC
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2058
mi
from 43215
Redding, CA
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251
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from 43215
Roanoke, VA
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411
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from 43215
Rome, GA
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1052
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Round Rock, TX
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1144
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San Antonio, TX
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1951
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San Diego, CA
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874
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from 43215
Sarasota, FL
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394
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from 43215
St Louis, MO
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966
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from 43215
Sunrise, FL
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2012
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Tacoma, WA
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Willow Grove, Pennsylvania 19090
417
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from 43215
Willow Grove, PA
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Wilmington, North Carolina 28401
484
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from 43215
Wilmington, NC
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604
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from 43215
Worcester, MA
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