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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00595920 |
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Date of registration:
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03/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
OLTERMS |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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116 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00595920 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward J Fox, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Central Texas Neurology Consultants |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Clinically Isolated Syndrome
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Multiple Sclerosis, Relapsing-Remitting
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Intervention(s)
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Biological: Tovaxin
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Primary Outcome(s)
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Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)
[Time Frame: Annually]
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Secondary Outcome(s)
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Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression
[Time Frame: Annually]
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Evaluate Changes in Annualized Relapse Rate
[Time Frame: Annually]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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