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 |
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.
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.
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
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