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Interferon beta

Avonex + Zocor for Multiple Sclerosis

Phase 3

Waitlist Available

Led By Emily S. Riser, MD

Research Sponsored by Alabama Neurology Associates, PC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant females age 18-55 with clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria

Subjects must be taking interferon therapy (Rebif, Avonex, or Betaseron) for 12 months with documented breakthrough disease (defined as >= 1 documented clinical relapse in the past 12 months or >= 1 documented Gd-enhancing lesion on cranial or spinal MRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing if a combination of two drugs is effective and safe for treating multiple sclerosis.

Who is the study for?

Adults aged 18-55 with relapsing-remitting Multiple Sclerosis, as per MacDonald criteria, and an EDSS score of 0-5. Participants must have had a clinical relapse or a Gd-enhancing lesion on MRI in the past year while on interferon therapy. They should not be pregnant or breastfeeding and must use acceptable contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of combining Avonex (an interferon therapy) with Zocor for those who have experienced breakthrough disease despite being on standard interferon treatment for at least one year.See study design

What are the potential side effects?

Potential side effects may include liver enzyme elevation, muscle pain or weakness (as indicated by CPK levels), allergic reactions to medication components, fatigue, flu-like symptoms from Avonex, and possible digestive issues from Zocor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18-55 years old and have relapsing-remitting MS.

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I've been on interferon therapy for MS with a relapse or new lesion in the last year.

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My disability due to MS is moderate or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

1. To evaluate the effect on Relapse Rates

Disease

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BiogenIndustry Sponsor

639 Previous Clinical Trials

467,292 Total Patients Enrolled

226 Trials studying Multiple Sclerosis

142,188 Patients Enrolled for Multiple Sclerosis

Alabama Neurology Associates, PCLead Sponsor

1 Previous Clinical Trials

912 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

912 Patients Enrolled for Multiple Sclerosis

Emily S. Riser, MDPrincipal Investigator

Media Library

Avonex (Interferon beta) Clinical Trial Eligibility Overview. Trial Name: NCT00242268 — Phase 3

Multiple Sclerosis Research Study Groups:

Multiple Sclerosis Clinical Trial 2023: Avonex Highlights & Side Effects. Trial Name: NCT00242268 — Phase 3

Avonex (Interferon beta) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00242268 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would people who are younger than 60 years old be able to join this research project?

"This trial only enrolls patients that are between 18-55 years old."

Answered by AI

Which type of person do you think would be best suited for this kind of medical research?

"This study is looking for 30 people with sclerosis who meet the following criteria: They must be between 18 and 55, have had at least one relapse in the past 12 months while on interferon therapy, and their Kurtzke EDSS score must be between 0 and 5.0. If you fit these qualifications and are willing to give written consent, please apply."

Answered by AI

Could you expand on the risks associated with this treatment?

"The safety of this Phase 3 trial's intervention has been evaluated as a 3."

Answered by AI

Are there any more places available for people who want to participate in this trial?

"This study appears to be on hiatus, as the last update was in December 2005. However, there are 563 other trials that patients may consider enrolling in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis

2005. "A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00242268.

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