Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis



Status:Terminated
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:November 2007
End Date:December 2008

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An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the
treatment of relapsing forms of multiple sclerosis.

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous
TERMS study will immediately be eligible for Tovaxin production and treatment in this open
label extension study. The MRTC negative subjects will be monitored quarterly for safety,
MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during
the monitoring phase will then be eligible for Tovaxin production and treatment in this
study.

Inclusion Criteria:

- Subjects who completed the TERMS study and received at least 1 study treatment
injection

- Signed and dated statement of informed consent

Exclusion Criteria:

- Pregnancy or breastfeeding

- Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin
in the TERMS study.

- Withdrew from TERMS study and did not continue participating in the remaining 52-week
core TERMS study assessments.

- Non-compliant with TERMS study.

- Diagnosis of progressive-relapsing, secondary progressive or primary progressive
Multiple Sclerosis (MS) while enrolled in the TERMS study.

- Medical, psychiatric or other conditions that compromise the subject's ability to
give informed consent, to understand the patient information, to comply with the
study protocol, or to complete the study.

- Any significant change in the subject's medical condition after enrollment in the
TERMS study which would have lead to his/her exclusion from participation in that
study.
We found this trial at
27
sites
Pompano Beach, Florida 33060
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8550 Marshall Dr.
Lenexa, Kansas 66214
913-894-1500
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Lenexa, KS
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3603 Paesanos Parkway
San Antonio, Texas 78231
210-614-4884
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San Antonio, TX
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Akron, OH
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Albany, New York 12205
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Albany, NY
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Augusta, GA
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Berkeley, CA
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Bradenton, Florida 34205
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Bradenton, FL
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Charlotte, North Carolina 28204
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Charlotte, NC
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Colorado Springs, Colorado 80919
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Colorado Springs, CO
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Columbus, Ohio 43221
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Columbus, OH
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Cullman, AL
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Dayton, Ohio
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Dayton, OH
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Fort Wayne, Indiana 46805
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Fort Wayne, IN
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Houston, TX
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Kirkland, Washington 98034
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Kirkland, WA
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Lebanon, New Hampshire 03766
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Lebanon, NH
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Lexington, Kentucky 40513
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Lexington, KY
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Mineola, NY
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Northbrook, Illinois 60062
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Northbrook, IL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Phoenix, AZ
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Phoenix, Arizona 85050
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Portland, OR
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Raleigh, North Carolina 27607
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Raleigh, NC
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Round Rock, Texas 78681
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Round Rock, TX
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Saginaw, MI
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