The Tysabri® “RESTORE” Study — an Interruption study of medication usage

Stuart SchlossmanMS Research Study and Reports, Multiple Sclerosis, Tysabri

FOR THOSE in FLORIDA, this study is taking place at Neurological Associates Research. – See information found below on How to contact this research center if interested in the study:

“Restore” Clinical Research Study – Criteria and study information found below

This is an Institutional Review Board (IRB) approved, (1) year study – Looking at a potential (6) months interruption of Tysabri


Criteria that you must meet:
  • You must Currently be on Tysabri
  • You must have been on Tysabri for at least 12 consecutive months
  • You must be between 18 and 60 years of age
  • You must be clinically stable (no relapses) for the past 12 months
  • You must not be pregnant, nursing, or planning on becoming pregnant in the next year


This study is expecting to enroll 200 people.

There are 2 parts to the study.

The first 6 months, people are randomly divided into 3 groups:

Group 1 (50 people) continue on Tysabri

Group 2 (50 people) go on placebo

Group 3 (100 people) go on either Avonex, Copaxone, or Solumedrol. If you are in this group, you may choose which of those 3 you will go on.

After the first 6 months, everyone goes back on Tysabri for the remaining 6 months.

If someone has a relapse in the first 6 months, they have the option of going directly back on Tysabri for 6 more months.

There are 11 visits. The first 6 months the visits are monthly. The second 6 months the visits are every 3 months. MRIs and lab work are done at every visit.


Patients will receive ALL study medication (regardless of which group you are in), MRIs, lab work, exams and study-related assessments at no charge for (1) year.


FOR THOSE in FLORIDA, contact : Neurological Associates Research if interested in being a study patient
572 East McNab Road – Suite 202 – Pompano Beach, Fl. 33060 – Brian Steingo, MD – Call : Cara at (954) 738-1686


IN Stuart’s own words, “I believe the purpose of this study is to see if stopping the use of Tysabri an d then the re-start is to determine if for example – if a patient has had 24 infusions and then is taken off Tysabri for 6 months, when they re-begin using Tysabri, are they re-beginning with infusion #25 or is their system re-booted causing them to now begin again with infusion #1.
A study much needed for determining long term usage of the medication”.



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