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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: |
NCT00501943 |
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Date of registration:
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12/07/2007 |
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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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Neuroprotection With Riluzole Patients With Early Multiple Sclerosis
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Scientific title:
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Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00501943 |
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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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Emmanuelle Waubant, 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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UCSF , MS Center |
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Name:
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Emmanuelle Waubant, 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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UCSF, MS Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient must give written informed consent;
2. Patients with a early MS or clinically isolated syndromes (CIS) in the past 12 months
as defined by an acute or sub-acute episode suggestive of demyelination affecting the
optic nerves, brain stem or spinal cord or other central nervous system location.
3. Entry age 18-55
4. Males and females
5. At least 2 silent T2 bright areas in the deep white matter on screening brain MRI.
6. No riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label
immunosuppressive drugs for MS prior to study entry
7. No corticosteroid during the 4 weeks prior to baseline MRI exam
8. No prior exposure to total lymphoid irradiation
9. No history of substance abuse, including documented alcohol dependence within 6 months
prior to screening or alcohol liver damage with AST , ALT > twice upper normal limits
10. No pregnant or nursing patients
11. No history of systemic illness or medical condition that would limit the likelihood of
completing the gadolinium-enhanced MRI procedures. Automatic exclusionary conditions
will include hypersensitivity reaction to riluzole or any of the tablets components,
uncontrolled hypertension, epilepsy, and insulin dependent diabetes, asthma, known
malignancy other than skin cancer, symptomatic cardiac disease or metallic objects on
or inside the body.
12. Patients willing to use birth control during the study.
13. Patients willing to go on Avonex therapy 3 months after being randomized to study drug
and no contra-indication to use of interferon therapy.
Exclusion Criteria:
1. A history of major depression or psychosis.
2. A clinically significant MS exacerbation within 30 days of the screening
3. Pregnancy
4. Abnormal screening liver function (AST or ALT > twice the upper normal limit).
5. Patients receiving hepatotoxic medications such as drugs interfering with CYP 1A2.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Avonex (Interferon beta 1a)
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Drug: Placebo
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Drug: Riluzole
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Primary Outcome(s)
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MRI Parameter- Percent Brain Volume Change for 2 Years
[Time Frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24]
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Secondary Outcome(s)
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Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)
[Time Frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24]
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Changes in Symbol Digit Modality Test (SDMT)
[Time Frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24]
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Changes in MS Functional Composite (MSFC)
[Time Frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24]
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Changes in Normalized White Matter Volumes (nWMV)
[Time Frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24]
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Changes in Normalized Grey Matter Volume
[Time Frame: Baseline, Month-3, Month-6, Month-12 and Month-24]
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Secondary ID(s)
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H9924-29155-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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