Relapsing Remitting Multiple SclerosisPhase 3NCT00242268
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
A Phase 3 study testing Simvastatin in people with Relapsing Remitting Multiple Sclerosis, run by Alabama Neurology Associates, PC at 1 site in United States.
Trial summary
The purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Simvastatin
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to not given
- Phase
- Phase 3
- 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
- Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria.
- Subjects must be taking some form of interferon therapy (Rebif, Avonex or Betaseron) for a duration of 12 months with documented breakthrough disease as defined:
- or = 1 documented clinical relapse in past 12 months while on interferon therapy. For eligibility, a pre-study relapse is defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute MS relapse.
- The relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
- OR
- > or = 1 documented Gd-enhancing lesion on cranial or spinal MRI. The presence of a Gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
- The Kurtzke EDSS score must be between 0- 5.0.
- All subjects must give written consent prior to evaluation and testing.
Who cannot join
- Subjects with primary or secondary progressive MS.
- Female patients may not be pregnant, attempting pregnancy or breastfeeding.
- Female subjects must use an acceptable form of contraception during the study as defined by the investigators. The rhythm method is not to be used as the sole method of contraception.
- Subjects unwilling or unable to give informed consent.
- Subjects that are NAB+ (titers > or = 20).
- Abnormal baseline blood test exceeding any of the limits defined below:
Show all 10Show fewer
- ALT or AST > 2x upper limit of normal (ULN)
- CPK > 2x upper limit of normal (ULN)
- Total WBC < 3,000/mm3
- No chronic infections (including HIV and Hepatitis B/C) may be present.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Alabama Neurology Associates
Birmingham, Alabama, 35209
Emily S. Riser, MD
About this study
The purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis.
Read the detailed description
Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; althoughthe majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers.
Zocor is in a class of drugs (statins) that are used to lower cholesterol. Statins also have an anti-inflammatory effect on the CNS. Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS. This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Simvastatin
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS
2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden
Secondary outcomes (2)
1. To evaluate the effect on Relapse Rates
2. To evaluate the effect on disease progression as measured with EDSS and MSFC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Alabama Neurology Associates, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Emily S. Riser, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242268
- Sponsor's protocol ID
- IST 03-09
- Status last verified
- Sep 2005
- First submitted
- 19 Oct 2005
- Last updated
- 7 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 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 Zocor in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00242268
- Acronym / sponsor ID
- IST 03-09
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Alabama Neurology Associates, PCUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Oct 2005
- First posted
- 20 Oct 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.
The purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis.
Detailed description
Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; althoughthe majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers.
Zocor is in a class of drugs (statins) that are used to lower cholesterol. Statins also have an anti-inflammatory effect on the CNS. Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS. This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI.
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 (8 listed)
- Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria.
- Subjects must be taking some form of interferon therapy (Rebif, Avonex or Betaseron) for a duration of 12 months with documented breakthrough disease as defined:
- The relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
- OR
- > or = 1 documented Gd-enhancing lesion on cranial or spinal MRI. The presence of a Gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
Key exclusion criteria (10 listed)
- Subjects with primary or secondary progressive MS.
- Female patients may not be pregnant, attempting pregnancy or breastfeeding.
- Female subjects must use an acceptable form of contraception during the study as defined by the investigators. The rhythm method is not to be used as the sole method of contraception.
- Subjects unwilling or unable to give informed consent.
- Subjects that are NAB+ (titers > or = 20).
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 |
|---|---|---|
| Simvastatin | Drug | – |
Primary outcome
1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS
2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden
2 secondary outcomes
1. To evaluate the effect on Relapse Rates
2. To evaluate the effect on disease progression as measured with EDSS and MSFC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Emily S. Riser, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin in people with Relapsing Remitting Multiple Sclerosis, run by Alabama Neurology Associates, PC 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 8 inclusion and 10 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 7 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 William T. White, Pharm.D. (205-979-7555, bwhite@sdr.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS. The study lists 2 primary outcomes in all. 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 7 Dec 2005.