Multiple Sclerosis (MS)


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Ongoing Clinical Trials


101MS326
  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis.
  • Purpose: To determine the effects of a specific FDA approved MS drug on cognition and MRI.
  • Eligibility:
    1. 18-58 y/o, male or female
    2. Diagnosis of secondary progressive multiple sclerosis for at least 2 years, with documented evidence of disease progression
    3. An EDSS score of 3.0-6.5
    4. Able to perform and complete all protocol visits and procedures
    5. Have not taken natalizumab (Tysabri) before 
  • Duration: up to 2.5 years
  • Principal Investigator: Adil Javed MD PhD
  • Study Coordinator: Mildred Valentine

CAMM
  • The University of Chicago and Dr. Javed are conducting a study for individuals who suffer form Relapsing-Remitting Multiple sclerosis who have relapsed on therapy.
  • Purpose: The purpose of this study is to test the effect of an experimental drug. The study also seeks to examine any side effects patients may experience when taking this study drug. There may be no direct benefit to a subject, but possible findings of this research study may lead to improved care for patients with Relapsing-Remitting Multiple Sclerosis who have relapsed on therapy.
  • Eligibility:
    1. male or female
    2. 18-50 years old
    3. Diagnosis of Relapsing-Remitting Multiple Sclerosis and have relapsed on therapy
    4. EDSS score of 0-5.0 inclusive
  • Duration: If you join the study you will be asked to come to the study site at least 10 times in a 2 year period.
  • Principal Investigator: Adil Javed MD PhD
  • Study Coordinator: Mildred Valentine

CBAF312A2201 (oral pill)
  • A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis.
  • Purpose: Compare safety, tolerability, efficacy of BAF312 vs. placebo on MRI lesions in relapsing-remitting MS.
  • Eligibility:
    1. Must be 18-55 y/o, male or female
    2. Must be diagnosed with relapsing remitting multiple sclerosis, with at least one documented relapse during the last year, or two documented relapses during the last two years, or have a positive Gadolinium-enhanced MRI scan during screening.
    3. Must have an EDSS score of 0-5.0
    4. Must be able to perform and complete all protocol visits and procedures.
  • Duration: 6 months
  • Principal Investigator: Jacqueline Bernard MD
  • Study Coordinator: Mildred Valentine

CFTY720D2306 (oral pill)
  • A double-blind, randomized, multi-center, placebo controlled, parallel-group tudy comparing the efficacy and safety of 1.25mg (FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.
  • Purpose: The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluate whether FTY720 is effective in delaying MS disability progression in the absence of relapses compared to placebo.
  • Eligibility:
    1. Male or female, 25-60 y/o
    2. EDSS score of 3.5-6.0
    3. Documented diagnosis of Primary Progressive Multiple Sclerosis
    4. One year of disease progression
    5. Two of the following:
      1. a) positive brain MRI (nine T2 lesions or four or more T2 lesions with positive visual evoked potential);
      2. b) positive spinal cord MRI (two focal T2 lesions);
      3. c) positive CSF.
    6. Central review of the evidence will be required to randomization. Patients who meet all three criteria (a, b & c) do not need to be submitted for central review.
  • Duration: up to three years.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Mildred Valentine

Drug Research Study for Relapsing/Remitting Multiple Sclerosis
  • Purpose: The purpose of this two year study is to determine the effects of a specific FDA approved MS drug on:
    • Cognition (memory, thought processes, etc.);
    • Specific MRI markers for cognition; and
    • Retinal nerve fiber layer thickness (RNFL) using optical coherence tomography (OCT), a special instrument used in ophthalmology.
  • We hope the information learned from this study will benefit other individuals with MS in the future.
  • Eligibility:
    1. Only Females 18 to 60 years old.
    2. Relapse/Remitting MS.
    3. EDSS (expanded disability status scale) 0 to 4.5.
  • Principal Investigator: Jacqueline Bernard MD
  • Study Coordinator: Mildred Valentine

EFC6058 (oral pill)
  • A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta.
  • Purpose: Assess the effect of Teriflunomide in comparison to placebo on the frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β).
  • Eligibility:
    1. Must be 18-56 y/o, male or female.
    2. Must be diagnosed with relapsing remitting multiple sclerosis, with at least one documented relapse during the last year, or 1 brain or spinal cord MRI lesion with at least 1 positive Gadolinium-enhanced MRI scan.
    3. Must have an EDSS score of 0-5.5 (able to walk 100 meters without aid or rest).
    4. Must be able to perform and complete all protocol visits and procedures.
  • Duration: up to 3.5 years.
  • Principal Investigator: Barry Arnason MD
  • Study Coordinator: Mildred Valentine

Estriol Research Study for Relapsing/Remitting Multiple Sclerosis
  • A Combination trial of copaxone plus Estriol in relapsing remitting multiple sclerosis.
  • Purpose: The purpose of this two year study is to determine:
    1. If the use of oral estriol in combination with Copaxone injection is safe;
    2. If the use of combination treatment causes a decrease in relapse rates;
    3. If there is more rapid improvement on brain MRI withi the combination treatment; and
    4. If there is an improvement in disability measures with the combination.
  • Eligibility:
    1. Only Females 18 to 50 years old.
    2. Relapse/Remitting MS..
    3. EDSS (expanded disability status scale) 0 to 4.5.
    4. Not on any other therapy for MS.
  • It is hoped that patients taking Estriol in combination with Copaxone injections will do better with their MS. We hope the information learned from this study will benefit other individuals with MS in the future.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Mildred Valentine

FTY720 in Relapsing/Remitting MS (Oral Treatment)
  • Enrollment is CLOSED. New experimental drug taken orally for relapsing/remitting MS. This two year research study will determine if a new experimental drug taken by mouth once daily can reduce the number of relapses in patients with relapsing/remitting MS compared to placebo. It will also evaluate how safe and well tolerated the experimental drug is when used for up to two years.
  • Eligibility:
    1. 18 to 55 years old
    2. Relapsing/Remitting MS
    3. EDSS score: 0 to 5.5 (able to walk 100 meters without aids)
    4. Must be available for clinic visits for the duration of the study
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Mildred Valentine

Single vs. Double-Dose Copaxone for Relapsing/Remitting MS
  • Enrollment is CLOSED. This two-year study will determine if an experimental dose of Copaxone is safe, tolerable, and more effective than the currently approved dose.
  • Principal Investigator: Adil Javed MD
  • Study Coordinator: Mildred Valentine

 


Completed Clinical Trials (data being analyzed)


Anti-B Cell Antibody (Rituxan) for Progressive MS
  • Enrollment is CLOSED; data is being analyzed.
  • Purpose: The purpose of this two and a half year study is to investigate an Anti-B cell antibody in the treatment of Primary Progressive MS.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Adil Javed MD, Avertano Noronha MD
  • Study Coordinator: Mildred Valentine

BEYOND Study for Relapsing/Remitting MS
  • Enrollment is CLOSED; data is being analyzed.
  • Purpose: The purpose of this two year study is to determine:
    1. If an experimental dose of a currently approved drug is safe, tolerable, and more effective than the currently approved dose.
    2. Which of two commonly used drugs is safer, more tolerable, and more effective in treating this disease.
  • Principal Investigator: Barry Arnason MD
  • Sub-Investigator(s): Roumen Balabanov MD, Adil Javed MD, Agnes Kim MD, Avertano Noronha MD, Anthony Reder MD, Darshan Shah
  • Study Coordinator: Mildred Valentine

Novantrone in MS
  • Enrollment is CLOSED; data is being analyzed.
  • Purpose: This is a phase IV monitoring study of the effects of Mitoxantrone/Novantrone in active MS. This drug was recently approved by the FDA, and is a form of chemotherapy that reduces the white blood cells that attack the brain. WBC, liver function, and cardiac function will be monitored.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Mildred Valentine

Rebif vs. Copaxone in Relapsing/Remitting MS
  • Enrollment is CLOSED; data are being analyzed.
  • Purpose: The purpose of this study is to compare the safety and effectiveness of two FDA approved drugs for the treatment of relapsing/remitting MS.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD
  • Study Coordinator: Mildred Valentine

 


Completed Clinical Trials (historical reference)


Antegren Phase II
  • Enrollment is CLOSED; completed in 2001.
  • Results: Showed that 6 monthly infusions of the antibody to the VLA-4 adhesion molecule were safe and reduced attacks by 50% and enhancing lesions on MRI by 80%-90%.

Antiproliferative Therapy of MS (Paclitaxel)
  • Enrollment is CLOSED.
  • Results: Cancelled because Phase II trial showed no effect.

Aricept Trial in MS
  • Enrollment is CLOSED; study terminated.
  • Results: This study compared placebo with Aricept to see if memory and cognitive function improved over 12 weeks. In a related study, this drug improved memory and thinking speed in MS.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Patricia Manning RN MSN, Bernadine Lake

ATM-027 Antibody to T Cell Receptor
  • Enrollment is CLOSED.
  • Results: Results: Study was closed by sponsor before patient enrollment.

Avonex (IFN beta-1a) for First Attack of MS-like Illness (optic neuritis, transverse myelitis, etc.)
  • Enrollment is CLOSED.
  • Results: Reduced the number of patients who developed MS.
  • Sponsor: Biogen
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Avertano Noronha MD

Betaseron (IFN beta-1b) for secondary-Progressive MS
  • Enrollment is CLOSED; study ended in 2000.
  • Purpose: IFN reduced attacks and MRI lesions, yet had minimal effect on patients who had progression without concurrent attacks.
  • Sponsor: Berlex Laboratories
  • Principal Investigator: Barry Arnason MD
  • Sub-Investigator(s): Avertano Noronha MD, Anthony Reder MD
  • Study Coordinator: Patricia Manning RN MSN

Betaseron (Interferon Beta-1b) for Relapsing/Remitting MS
  • Enrollment is CLOSED; study finished in 1993; Betaseron APPROVED by FDA in 1993.
  • Results: Betaseron reduced relapses and active MRI lesions, and improved visual memory. This became the first biological agent to be approved by the FDA to treat MS.
  • Sponsor: Berlex Laboratories
  • Principal Investigator: Barry Arnason MD
  • Sub-Investigator(s): Avertano Noronha MD, Anthony Reder MD

Betaseron: Prevention of Red Spots at Skin Injection Sites
  • Enrollment is CLOSED; completed in 2002; analysis is on-going.
  • Results: Trial looked at prevention of erythma (red spots) with steriod cream at site of Betaseron injection.
  • Principal Investigator: Barry Arnason MD
  • Study Coordinator: Patricia Manning RN MSN

Copaxone (Cop1; Glatiramer acetate) in Primary progressive MS
  • Enrollment is CLOSED; study terminated.
  • Results: Subcutaneous injections of Copaxone are not effective in slowing the progression of primary progressive multiple sclerosis. The study lasted two and one half years. Later analysis suggested modest benefit in men but not women.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD
  • Research Nurse: Patricia Manning RN MSN
  • Study Coordinator: Lily Wong MA, Barbara Harding-Clay

Copaxone Oral
  • Enrollment is CLOSED.
  • Results: The study evaluated the efficacy of oral Copaxone in reducing relapse rates and new MRI lesions. Results: No significant effect, just as with oral myelin. A high-dose repeat trial is under consideration.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD
  • Research Nurse: Patricia Manning RN MSN
  • Study Coordinator: Lily Wong MA

Cyclosporin for MS
  • Enrollment is CLOSED; study terminated by sponsor due to renal toxicity, 1986.
  • Results: Some slowing of MS progression.
  • Sponsor: Sandoz
  • Principal Investigator: Barry Arnason MD
  • Sub-Investigator(s): Mark Aguis MD, Anthony Reder MD

Cytotek (Misoprostol) for MS
  • Enrollment is CLOSED; study finished in 1997.
  • Results: This drug is approved for other indications and is available for use in MS. Cytotek significantly reduces pain from trigeminal neuralgia (tic douloureux) in MS in patients who have failed all other drug therapies.
  • Sponsor: G.D. Searle
  • Principal Investigator: Anthony Reder MD
  • Resident Participation: Debra Babcock MD

Hu23F2G for Acute Exacerbation of MS
  • Enrollment is CLOSED; study ended in 1999.
  • Results: Monoclonal antibody against the LFA-1 adhesion molecule - to stop homing of lymphocytes to the brain. No effect on MS.
  • Sponsor: ICOS
  • Sub-Investigator(s): Avertano Noronha MD
  • Study Coordinator: Patricia Manning RN

(IFN-beta 1b) Betasron Double-Dose (Phase II)
  • Enrollment is CLOSED; completed in 2005.
  • Results: This two year study determined that a very high dose of interferon reduced MRI lesions in relapsing/remitting MS by 40% compared to the FDA approved dose of Betaseron.
  • Principal Investigator: Barry Arnason MD
  • Sub-Investigator(s):: Adil Javed MD, Avertano Noronha MD, Anthony Reder MD

Linomide for Secondary Progressive MS
  • Enrollment is CLOSED; study terminated in 1997 due to side effects.
  • Results: Linomide reduced clinical and MRI activity in MS, but caused heart attacks.
  • Sponsor: Pharmacia
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD

Natalizumab (Tysabri) Antibody to Adhesion Molecules VLA-4
  • Enrollment is CLOSED.
  • Results: This two and a half year study looked at a new method for blocking the VLA-4 adhesion molecule that allows white blood cells to stick to blood vessels in the brain. Monthly infusions of the monoclonal antibody reduced relapses by 66% and slowed progressions. (See results of Phase II trial above.)
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Adil Javed MD, Avertano Noronha MD
  • Study Coordinator: Mildred Valentine

(Avandia) PPAR-gamma agonists in Remitting/Relapsing MS
  • Enrollment is CLOSED; completed in 2004.
  • Results: This one year showed no effect of an oral diabetes pill on reducing MRI lesions, MS attacks, and MS progression.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD
  • Study Coordinator: Mildred Valentine

MBP8298-SP-03
  • Enrollment is CLOSED; completed in 2009.
  • A double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of MBP8298 in subjects withi secondary progressive Multiple Sclerosis. MBP8298 is given intravenously (i.v.). Study treatment for 24 months, and follow-up visits.
  • Primary Objective: To compare the clinical efficacy and safety of 500mg MBP8298 given i.v. every six months, to placebo.
  • Eligibility Criteria:
    • Male or Female, 18 to 65 years of age.
    • Test Positive for HLA (DR2 or DR4) blood group protein.
    • Documented history of Secondary Progressive Multiple Sclerosis. Not RRMS or PPMS.
    • Subjects must have had an absence of relapses in the 3 months prior to the baseline visit.
    • EDSS score of 3.0 - 6.5
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Mildred Valentine

Rebif vs. Avonex Trial
  • Enrollment is CLOSED; study is on-going.
  • Purpose: This six month study compared the therapeutic effect of two IFN beta-1 therapies for relapsing-remitting multiple sclerosis. Participants will receive monthly MRI exams. Results: Rebif reduced the attack rate and MRI lesions faster than Avonex.
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD, Avertano Noronha MD
  • Study Coordinator: Patricia Manning RN MSN

Rebiject Trial in MS
  • Enrollment is CLOSED; study ended in 2004.
  • Results: Rebiject device was effective.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Patricia Manning RN MSN

T Cell Receptor Vaccine for MS
  • Enrollment is CLOSED. A phase II study of a peptide vaccine to inhibit brain-reactive cells. Results: Contact sponsor for the results of this trial.
  • Sponsor: Connective Therapeutics
  • Principal Investigator: Anthony Reder MD

Tegison (Vitamin A) for MS

Terbutaline in Chronic Progressive MS
  • Enrollment is CLOSED; study completed in 1995; drug is available.
  • Results: Terbutaline may reduce fatigue in MS and correct immune abnormalities.
  • Sponsor: The University of Chicago Medical Center
  • Principal Investigator: Ewa Chelmicka-Schorr MD
  • Sub-Investigator(s): Barry Arnason MD, Anthony Reder MD

Tizanidine for Spasticity in MS
  • Enrollment is CLOSED; study finished in 1995; drug approved by FDA in 1997.
  • Results: Contact Athena Neurosciences for drug information.
  • Sponsor: Athena Neurosciences
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Barry Arnason MD

TNFR-IgG (Lenercept; RO45-2081) for Relapsing/Remitting MS
  • Enrollment is CLOSED; study terminated in 1997.
  • Results: Drug caused more MS attacks, despite reducing MRI lesions.
  • Sponsor: Hoffman LaRoche
  • Principal Investigator: Anthony Reder MD
  • Sub-Investigator(s): Avertano Noronha MD

Zanaflex for Spasticity in MS and Spinal Cord Damage
  • Enrollment is CLOSED; study is on-going.
  • Results: Trial will look at the effects of Zanaflex on spasticity and blood pressure.
  • Principal Investigator: Anthony Reder MD
  • Study Coordinator: Patricia Manning RN MSN