Multiple Sclerosis, Relapsing-RemittingPhase 1NCT00242177
Pilot Test of ACTOS in Multiple Sclerosis: Safety and Tolerability
A Phase 1 study testing ACTOS (Pioglitazone) in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- ACTOS (Pioglitazone)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2005
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be signed and dated Clinically or laboratory definite RR MS Mild symptoms, with current EDSS between 1 and 6.5, and ambulatory Currently taking, and history (>= 1 year) of taking Avonex or Rebif No relapses in past 3 months Historical annual relapse rate of >=1.0 for the past 2 years Male or female, age 18 to 65 No history of liver disease, hypoglycemia, or cardiac related diseases Ability to carry out requirements for participation Not meeting any exclusion criteria
Who cannot join
- Not meeting all inclusion criteria If female, pregnant, or intent to become pregnant or breast feed during trial Unable to give written consent Unable to carry out requirements of trial History of other neurological disease History of cardiovascular disease History of liver disease History of hypoglycemia History of high blood pressure HIV positive Exacerbation within 90 days of enrollment Intolerance to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
The purpose of this study is to determine whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients.
Read the detailed description
- 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.
- 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
- 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.
- There are no known benefits from participating in this trial; however the knowledge gained may benefit others in the future.
- 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- ACTOS (Pioglitazone)
- Keywords
- Multiple Sclerosis, Relapsing, Remitting, Autoimmune disease
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTOS (Pioglitazone)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI with GD enhancement at visit 2, 5, 8
Blood test (CBC, Liver enzymes)at each visit
EDSS at each visit
MSFC at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startOct 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Douglas L Feinstein, University of Illinois Chicago
- Investigators
- Douglas L Feinstein, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242177
- Sponsor's protocol ID
- 2003-0547
- Status last verified
- Jul 2019
- First submitted
- 18 Oct 2005
- Last updated
- 22 Jul 2019
- Results posted
- No
Publications
Pershadsingh HA, Heneka MT, Saini R, Amin NM, Broeske DJ, Feinstein DL. Effect of pioglitazone treatment in a patient with secondary multiple sclerosis. J Neuroinflammation. 2004 Apr 20;1(1):3. doi: 10.1186/1742-2094-1-3.
PubMed 15285799Schmidt S, Moric E, Schmidt M, Sastre M, Feinstein DL, Heneka MT. Anti-inflammatory and antiproliferative actions of PPAR-gamma agonists on T lymphocytes derived from MS patients. J Leukoc Biol. 2004 Mar;75(3):478-85. doi: 10.1189/jlb.0803402. Epub 2003 Dec 4.
PubMed 14657213Feinstein DL, Galea E, Gavrilyuk V, Brosnan CF, Whitacre CC, Dumitrescu-Ozimek L, Landreth GE, Pershadsingh HA, Weinberg G, Heneka MT. Peroxisome proliferator-activated receptor-gamma agonists prevent experimental autoimmune encephalomyelitis. Ann Neurol. 2002 Jun;51(6):694-702. doi: 10.1002/ana.10206.
PubMed 12112074
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of ACTOS in Multiple Sclerosis: Safety and Tolerability
- ClinicalTrials.gov ID
- NCT00242177
- Acronym / sponsor ID
- 2003-0547
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing, Remitting, Autoimmune disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Oct 2003
- Study completion
- Oct 2005
- First posted
- 19 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 whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients.
Detailed description
- 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.
- 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
- 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.
- There are no known benefits from participating in this trial; however the knowledge gained may benefit others in the future.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent must be signed and dated Clinically or laboratory definite RR MS Mild symptoms, with current EDSS between 1 and 6.5, and ambulatory Currently taking, and history (>= 1 year) of taking Avonex or Rebif No relapses in past 3 months Historical annual relapse rate of >=1.0 for the past 2 years Male or female, age 18 to 65 No history of liver disease, hypoglycemia, or cardiac related diseases Ability to carry out requirements for participation Not meeting any exclusion criteria
Key exclusion criteria (1 listed)
- Not meeting all inclusion criteria If female, pregnant, or intent to become pregnant or breast feed during trial Unable to give written consent Unable to carry out requirements of trial History of other neurological disease History of cardiovascular disease History of liver disease History of hypoglycemia History of high blood pressure HIV positive Exacerbation within 90 days of enrollment Intolerance to MRI
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 |
|---|---|---|
| ACTOS (Pioglitazone) | Drug | – |
Primary outcome
MRI with GD enhancement at visit 2, 5, 8
Blood test (CBC, Liver enzymes)at each visit
EDSS at each visit
MSFC at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Background: PubMed 15285799Pershadsingh HA, Heneka MT, Saini R, Amin NM, Broeske DJ, Feinstein DL. Effect of pioglitazone treatment in a patient with secondary multiple sclerosis. J Neuroinflammation. 2004 Apr 20;1(1):3. doi: 10.1186/1742-2094-1-3.
- Background: PubMed 14657213Schmidt S, Moric E, Schmidt M, Sastre M, Feinstein DL, Heneka MT. Anti-inflammatory and antiproliferative actions of PPAR-gamma agonists on T lymphocytes derived from MS patients. J Leukoc Biol. 2004 Mar;75(3):478-85. doi: 10.1189/jlb.0803402. Epub 2003 Dec 4.
- Background: PubMed 12112074Feinstein DL, Galea E, Gavrilyuk V, Brosnan CF, Whitacre CC, Dumitrescu-Ozimek L, Landreth GE, Pershadsingh HA, Weinberg G, Heneka MT. Peroxisome proliferator-activated receptor-gamma agonists prevent experimental autoimmune encephalomyelitis. Ann Neurol. 2002 Jun;51(6):694-702. doi: 10.1002/ana.10206.
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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.
Douglas L Feinstein, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACTOS (Pioglitazone) in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Illinois Chicago 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI with GD enhancement at visit 2, 5, 8. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242177, which also lists 3 linked publications.
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 22 Jul 2019.