Multiple SclerosisPhase 2NCT00217295
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Avonex and Topamax in people with Multiple Sclerosis, run by Multiple Sclerosis Institute at 1 site in United States.
Trial summary
This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression. 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 and Topamax
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Relapsing-remitting multiple sclerosis
- -
Who cannot join
- Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
Trial locations and contacts
1 site in 1 country.
Jeffrey I Greenstein, MD contact
United States1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Institute
Philadelphia, Pennsylvania, 19146
Jeffrey I Greenstein, MD, 215-985-2245
Iris J Gold, MBA, 215-985-2245
About this study
Official title: A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.
Read the detailed description
The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.
- Conditions
- Multiple Sclerosis
- Being tested
- Avonex and Topamax
- Keywords
- Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avonex and TopamaxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Secondary outcomes (3)
Brain atrophy on nMRI
Disease progression on EDSS and MSFC
Relapse rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Multiple Sclerosis Institute
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey I Greenstein, MD, Principal investigator, MSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217295
- Sponsor's protocol ID
- MSI-101
- Other IDs
- BiogenIdec, Ortho-McNeil
- Status last verified
- Jun 2005
- First submitted
- 14 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00217295
- Acronym / sponsor ID
- MSI-101
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Multiple Sclerosis InstituteUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Dec 2007
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.
Detailed description
The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Relapsing-remitting multiple sclerosis
- -
Key exclusion criteria (1 listed)
- Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avonex and Topamax | Drug | – |
Primary outcome
Safety and tolerability
3 secondary outcomes
Brain atrophy on nMRI
Disease progression on EDSS and MSFC
Relapse rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey I Greenstein, MD contact
Jeffrey I Greenstein, MD principal investigator
MSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avonex and Topamax in people with Multiple Sclerosis, run by Multiple Sclerosis Institute 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2005. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey I Greenstein, MD (215-985-2245), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2005; AzTrials last refreshed its copy on 26 Oct 2026.