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Multiple SclerosisPhase 2NCT00501943

Neuroprotection With Riluzole Patients With Early Multiple Sclerosis

A Phase 2 study testing Avonex (Interferon beta 1a) and Riluzole in people with Multiple Sclerosis, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a double blind, randomized, parallel group design placebo-controlled mono-center study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2 silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be offered participation in the study. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Avonex (Interferon beta 1a) and Riluzole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
1 siteUnited States
Study dates
Jul 2006to Oct 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient must give written informed consent;
  • 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.
  • Entry age 18-55
  • Males and females
  • At least 2 silent T2 bright areas in the deep white matter on screening brain MRI.
  • No riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label immunosuppressive drugs for MS prior to study entry
Show all 13Show fewer
  • No corticosteroid during the 4 weeks prior to baseline MRI exam
  • No prior exposure to total lymphoid irradiation
  • 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
  • No pregnant or nursing patients
  • 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.
  • Patients willing to use birth control during the study.
  • Patients willing to go on Avonex therapy 3 months after being randomized to study drug and no contra-indication to use of interferon therapy.

Who cannot join

  • A history of major depression or psychosis.
  • A clinically significant MS exacerbation within 30 days of the screening
  • Pregnancy
  • Abnormal screening liver function (AST or ALT > twice the upper normal limit).
  • Patients receiving hepatotoxic medications such as drugs interfering with CYP 1A2.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF MS Center , 675 Nelson Rising Lane, Suite 221

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis

This is a double blind, randomized, parallel group design placebo-controlled mono-center study. Patients will be evaluated within twelve months of CIS onset. Patients with at least 2 silent ovoid T2 bright areas in the deep white matter on their clinic brain MRI scan will be offered participation in the study. Patients will be randomized to oral riluzole or placebo (1:1). Patient will take 50 mg of riluzole or placebo once a day for one month. If 50 mg once a day is well tolerated, patients will then go on 50 mg twice daily for the rest of the study. They will start Avonex (Interferon beta 1a) therapy 30 mcg IM once weekly 3 months after study drug (riluzole or placebo) is initiated if their liver function has remained normal.

Forty patients within twelve months of onset CIS onset will be enrolled at UCSF MS Center. Patients will be evaluated every month for the first 12 months and every three months thereafter for a total study duration of 24-month. Enrollment period will last six months.

Read the detailed description

To determine the effect of riluzole up to 50 mg bid on MRI parameters, including T1 lesions load, atrophy of gray and white matter, and 1H-MRSI; and to determine safety of riluzole when administered orally up to 50 mg bid for 2 years in double blinded clinical trial of patients with clinically isolated syndromes (CIS) and at least 2 silent T2-bright areas in the deep white matter. These patients have a high risk of conversion to MS within 2 years and faster rate of atrophy (Dalton 2004).

Specific aims:

  1. To determine the effect of treatment compared to placebo on annual change in measures of normalized brain gray and white matter volume changes.
  2. To determine the effect of riluzole compared to placebo on annual change in proton spectroscopic intensities of N-acetyl aspartate (NAA) and glutamate in normal appearing white matter (NAWM), in acute and chronic lesions.
  3. To determine the safety of riluzole up to 50 mg bid in patients with CIS in association to Avonex (Interferon beta 1a) 30 mcg IM once a week.
  4. To monitor changes on MS functional composite (MSFC) (Cutter 1999, Rudick 1998), optic coherence tomography (OCT), low contrast sensitivity and EDSS in these patients.
  5. To monitor recovery from exacerbations.
Being tested
Avonex (Interferon beta 1a), Riluzole, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avonex (Interferon beta 1a)Drug

  • RiluzoleDrug

  • PlaceboDrug

Study groups in NCT00501943
Study groupRoleWhat they receive
RiluzoleActive comparatorRiluzole + Avonex
Receives: Drug: Avonex (Interferon beta 1a); Drug: Riluzole
PlaceboPlacebo comparatorplacebo + Avonex
Receives: Drug: Avonex (Interferon beta 1a); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI Parameter- Percent Brain Volume Change for 2 Years

    Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)

    Measured: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

Secondary outcomes (5)

  1. Changes in Normalized White Matter Volumes (nWMV)

    The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX

    Measured: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

  2. Changes in MS Functional Composite (MSFC)

    Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.

    Measured: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

  3. Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)

    Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).

    Measured: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

  4. Changes in Symbol Digit Modality Test (SDMT)

    Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).

    Measured: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24

  5. Changes in Normalized Grey Matter Volume

    The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX

    Measured: Baseline, Month-3, Month-6, Month-12 and Month-24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00501943
Sponsor's protocol ID
H9924-29155-05
Status last verified
Mar 2014
First submitted
12 Jul 2007
Last updated
9 Apr 2014
Data monitoring committee
Yes

Publications

  • Kuhle J, Nourbakhsh B, Grant D, Morant S, Barro C, Yaldizli O, Pelletier D, Giovannoni G, Waubant E, Gnanapavan S. Serum neurofilament is associated with progression of brain atrophy and disability in early MS. Neurology. 2017 Feb 28;88(9):826-831. doi: 10.1212/WNL.0000000000003653. Epub 2017 Feb 1.

    PubMed 28148632

  • Maghzi AH, Graves J, Revirajan N, Spain R, Liu S, McCulloch CE, Pelletier D, Green AJ, Waubant E. Retinal axonal loss in very early stages of multiple sclerosis. Eur J Neurol. 2015 Jul;22(7):1138-41. doi: 10.1111/ene.12722. Epub 2015 Apr 29.

    PubMed 25929276

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avonex (Interferon beta 1a) and Riluzole in people with Multiple Sclerosis, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI Parameter- Percent Brain Volume Change for 2 Years (time frame: Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00501943, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.

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