Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242177
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2005-10-18
Brief Title:
Pilot Test of ACTOS in Multiple Sclerosis Safety and Tolerability
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Pilot Test of ACTOS in Multiple Sclerosis Safety and Tolerability
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients
Detailed Description:
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 its 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None