NCT00242177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

First QC Date

October 18, 2005

Last Update Submit

July 18, 2019

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple SclerosisRelapsing, RemittingAutoimmune disease

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

ACTOS (Pioglitazone)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • 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.

    PMID: 15285799BACKGROUND

  • Schmidt 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.

    PMID: 14657213BACKGROUND

  • Feinstein 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.

    PMID: 12112074BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisRecurrenceAutoimmune Diseases

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Douglas L Feinstein, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor, Dept Anesthesiology

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 19, 2005

Study Start

October 1, 2003

Study Completion

October 1, 2005

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

US(1)