Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Pilot Test of ACTOS in Multiple Sclerosis: Safety and Tolerability
The purpose of this study is to determine whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients.
1. Current treatments for Multiple Sclerosis (MS) only partially reduce the relapse rate or
improve symptoms, have to be injected, and have side effects. In animal models of MS,
the FDA-approved oral anti-diabetic drug ACTOS prevented and reduced symptoms. ACTOS has
a good safety profile in diabetics and healthy volunteers, but it's effects in MS are
not known. This trial will test the safety of taking daily ACTOS in Relapsing Remitting
MS (RRMS) patients, the most common form of MS. Subjects will take ACTOS or a non active
pill (placebo) every day, and during the trial the safety of the drug will be tested by
doing blood tests for certain enzymes related to liver function, for glucose levels, by
having the blood pressure measured, and having other routine laboratory blood tests
carried out. The safety of ACTOS on MS disease will be tested by doing neurological
examinations, Magnetic Resonance Imaging (MRI, a method which gives an image of the
damage MS causes in brain), and other blood tests to make sure that the MS symptoms are
not made worse by ACTOS. Findings that ACTOS is safe and tolerated in RRMS patients will
help provide the basis for designing Phase II trials.
2. Subjects will be selected who have been diagnosed with RR-MS and who are taking the drug
Avonex or Rebif to treat their MS symptoms. Subjects will be randomized to receive
either ACTOS (30 mg) or a non-active tablet (placebo). Both the subjects and the
investigator will be blinded meaning no-one will know which pill they are given. The
subjects will take one pill daily by mouth for up to 18 months, the length of the trial.
During the trial, subjects will be examined 8 times. At each visit about 3 tablespoons
(30cc) of blood will be taken for tests. Subjects will have a total of 3 MRI scans done
during the trial (at months 0, 5, and 12) to test if ACTOS effects the number or size of
plaques in brain. At each visit the subjects will also have vital signs checked, and a
urine pregnancy test performed
3. ACTOS can cause fluid retention which may cause or increase the risk of heart damage.
ACTOS can cause mild weight gain or anemia (low hemoglobin levels). ACTOS can cause mild
hypoglycemia (low blood sugar levels). ACTOS can increase ovulation and increase risk of
pregnancy. Since ACTOS is structurally related to Troglitazone, which was associated
with liver damage and rare cases of liver failure, patients treated with ACTOS are
carefully monitored for changes in liver enzyme levels. In other studies with ACTOS, the
most common side effects were upper respiratory tract infections, sinusitis, muscle
pain, tooth disorder, sore throat, headache and gas. ACTOS may have other side effects,
such as heartburn, diarrhea, constipation, dizziness, abdominal fullness, nausea, and
loose stools.
MRI is a FDA approved safe procedure. Possible risks include feelings of anxiety or
claustrophobia, or disturbance by noise made during the procedure. A safe contrast agent
(gadolinium) will be used for MRI. Injection and insertion of the needle may cause minor
pain, bruising, and/or infection at the injection site. Gadolinium may cause brief
discomfort, tingling, or warmth in the lips, or metallic taste in the mouth, tingling in
the arm, nausea, or headache. Very rarely, there may be an allergic reaction. A standard
questionnaire will be used to determine the safety for each patient before an MRI.
Blood sample collection has risks of edema, swelling, or infection at the site of
withdrawal.
We will discuss all of the above in the consent form as outlined in the form with the
candidates.
4. There are no known benefits from participating in this trial; however the knowledge
gained may benefit others in the future.
5. This trial will recruit 30 RR MS patients. Approximately 10 male and 20 female patients
will be recruited, with about equal numbers coming from the UIC and Rush. Patients can
be between the ages of 18-64 yrs, and will be obtained from outpatient clinics. Consent
process will follow standardized forms.
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