People with MS can take an active role in freeing the world of MS by participating in drug studies. Below are local clinical trials and research studies that are currently enrolling participants.
Read answers to Frequently Asked Questions on clinical trials for more information.
Saint Louis University
A Multi-Center Study of the Efficacy and Safety of Teriflunomide in Patients with Relapsing Multiple Sclerosis who are Treated with Interferon-Beta
Location of Trial: Saint Louis University Dept. of Neurology & Psychiatry
Monteleone Hall 1438 S. Grand Blvd. St. Louis, MO 64104
Description:
The study will have 2 treatment groups: one group will receive interferon-beta plus placebo, the second group will receive interferon-beta plus teriflunomide. The trial will have approximately 465 patients in the placebo group and approximately 930 patients in the teriflunomide group.
Participant Criteria:
Inclusion criteria are: Patients with relapsing forms of multiple sclerosis, who are treated with interferon-beta.
Subjects will be excluded if they have: Less than 18 years and more than 56 years of age, non-ambulatory, not treated with a stable dose of interferon-beta for at least 6 months, any unstable medical or psychiatric condition, or a relapse within 30 days prior to randomization.
Length of Trial: 48 Weeks
Clinical Trial Sponsor: Sanofi-Aventis
Contact: Susan Eller, MA, RN, CCRC 314-977-4867 or ellersc@slu.edu
Characterization of Symptom Occurrence in Persons with Multiple Sclerosis
Program Description: Be a part of a nursing study to examine the impact of symptoms in persons with relapsing-remitting MS offered by Dr. Florian Thomas and Pamela Newland, RN, PhD. Participation will involve completing questionnaires, which will take approximately 1-1/2 hours. Volunteers will be compensated.
Participant Criteria: Patients must have a diagnosis of relapsing remitting multiple sclerosis and be over 18 years old.
Clinical Trial Sponsor: National Institute of Health / National Institute of Nursing Research
Contact: Pamela Newland, RN, PhD, CMSRN, 618.650.2972, pnewlan@siue.edu
How Symptoms and Other Diseases Affects MS
Research is needed to study how symptoms and other disease (such as high blood pressure) affect people with MS and other neurologic disorders over time. Investigators at the University of Washington and Saint Louis University are collecting data from 2000 people, including 500 with MS, on the frequency, course, and impact of secondary symptoms such as pain, fatigue, and depression, as well as data on participation in employment, communication, and other facets of life. Participants will complete a short online survey, which takes about 15 minutes. Data are kept confidential and participants can refuse to answer any questions they choose.
Follow this link to the Survey:
Take the Survey
Or copy and paste the URL below into your internet browser:
https://siue.us2.qualtrics.com/SE/?SID=SV_9pOylpA2GSFc0cs
For more information, contact Pamela Newland at pnewlan@siue.edu
EFC6260: An International, multi-center trial to evaluate the efficacy and safety of Teriflunomide versus placebo in patients with a first clinical episode suggestive of multiple sclerosis.
Description: This is an investigational drug being used to evaluate the effectiveness and the potential risks of Teriflunomide 7mg and 14mg in patients presenting with their first neurological episode suggestive of MS and who have abnormalities on a brain MRI that shows the risk of developing MS.
Participant Criteria: Participants must present with their first acute neurological event consistent with demyelination.
1) Age 18-55
2) Onset of MS symptoms within 60 days of randomization
Subjects will be excluded if they have been treated for MS, any unstable medical conditions.
Length: 2 years
Clinical Trial Sponsor: Sanofi-Aventis
Contact: Susan Eller, MA, RN, CCRC, 314-977-4867, ellersc@slu.edu
The Clinical Implications of Limb Apraxia and Associated MRI Findings in Patients with Multiple Sclerosis
Description: The purpose of this study is to investigate how often limb apraxia and disabilities occur in a group of patients with multiple sclerosis.
Participant Criteria: Age 18-70. Patients must have a diagnosis of relapsing-remitting MS or Secondary Progressive MS.
Length: One year
Sponsor: Pfizer/Serono
Contact: Susan Eller, (314) 977-4900, or ellersc@slu.edu
John L. Trotter MS Center &
Washington University
School of Medicine
Hippotherapy and Older Adults
Location of Trial: Two 2-hour sessions at Washington University in Saint Louis, MO. The intervention sessions will be held at Exceptional Equestrians in Washington, MO.
Description: The Human Performance Laboratory in the Department of Occupational Therapy at Washington University in St. Louis (Wash U) is collaborating with a local therapeutic riding center to investigate the effect of hippotherapy (horseback riding therapy) on balance, fall risk, and participation in older adults (ages 55 - 75).
Potential participants will first receive an assessment from an occupational therapist. If they meet the study criteria and commit to the study they will participate in a two hour testing session at Washington University in St. Louis. They will then ride a horse for 45 minutes, once or twice per week for 5 -12 weeks doing mounted therapeutic activities under the direct supervision of a licensed therapist with a horse leader and sidewalkers for safety. After the mounted therapy sessions they will participate in another two hour testing session. The testing will consist of answering questions and having small reflective markers placed on the legs, trunk and head. Participants will stand still, walk and will ride a motorized barrel in the laboratory for several 15 - 20 second test while video cameras measure their ability to control body movements. The preliminary assessment, the mounted therapy sessions and laboratory testing will be free to the participants.
Participant Criteria: 55+ years old. Individuals diagnosed with Multiple Sclerosis (MS) are encouraged to apply. Maximum score of greater than or equal to 67% on ABC (Activities specific Balance Confidence Scale - as assessed through a phone interview). Able to sit unaided on static surface with no back support. Able to sit astride an appropriately sized horse and an 18" diameter testing barrel. Able to follow directions that ask you to do more than one thing. Approved consent from primary physician after reviewing candidate for PATH list of precautions and contraindications for mounted therapy. (http://www.pathintl.org/resources-education/resources/eaat/203-precautions-and-contraindications)
Contact Exceptional Equestrians of the Missouri Valley at 636.390.2141 or Dr. Tim Shurtleff (Principal Investigator) at 314.289.4323 for a full list.
Length of Trial: 5 - 12 weeks
Clinical Trial Sponsor: The Human Performance Laboratory in the Department of Occupational Therapy at Washington University in St. Louis.
For more information please contact:
Student investigators:
Lisa Wehofer MSOT/S, at wehoferl@wusm.wustl.edu or 719.659.1426
Nicole Wittman Goodson, MSOT/S, at wittmann@wusm.wustl.edu or 812.499.1762
Or call the Human Performance Laboratory in the Occupational Therapy department at Washington University at 314.289.4323, or Exceptional Equestrians of the Missouri Valley at 636.390.2141
Teracles
Description:
A trial of addition of teriflunomide pills to any beta-interferon. Two-thirds of patients receive active teriflunomide, 1/3rd receive placebo pills. All patients continue the beta-interferon they have been taking. Teriflunomide is the active metabolite of the drug Arava, FDA-approved for rheumatoid arthritis since 1998.
Participant Criteria:
Relapsing MS between 18 and 55 yrs old. Either a clinical attack or an enhancing lesion on a gadolinium MRI scan within the past 12 months, despite taking any beta-interferon.
Length of Trial:
68 weeks to 144 weeks (depending upon when entered)
Clinical Trial Sponsor: Sanofi-Aventis
Contact: Susan Fox, 314 362-2017, foxs@neuro.wustl.edu
Principal Investigator: Anne Cross MD
Protocol 205MS301
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon β-1a) in Patients with Relapse-Remitting Multiple Sclerosis
Location of Trial: Worldwide, including John L. Trotter MS Center at Washington University
Description: Evaluate the effectiveness and potential risks of DAC HYP versus IFN β-1a in patients with RRMS.
Participant Criteria: Males and females aged 18-55 years
• Patients with RRMS who are able to walk at least 100 meters (about 100 yards)
without the aid of a cane.
• NEVER treated with daclizumab or other anti-CD25 monoclonal antibody.
Length of Trial:
At least 96 weeks, but no more than 144 weeks. All subjects who complete the study may be eligible for an open-label extension study with DAC HYP.
Clinical Trial Sponsor: Biogen Idec LTD
Contact: Susan Fox, Clinical Coordinator, 314-362-2017
Protocol CFTY720D2306
A double-blind, randomized, multi-center, placebo-controlled, parallel group study comparing the efficacy and safety of 0.5 mg FTY70 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis
Location of Trial: Worldwide, including John L. Trotter MS Center at Washington University
Description: Evaluate the effectiveness and potential risks of a study drug FTY720 in patient with PPMS.
Participant Criteria: Males and females aged 25-65
• Patients with PPMS who are able to walk at least 100 meters (about 100 yards)
without the aid of a cane or assistance.
• You don’t have a history of MS attack or relapse.
Length of Trial:
The study will last approximately 3-5 years, with 20-28 outpatient study visits.
Sponsor: Novartis Pharmaceuticals
Contact: Sherry Banez-Muth, Clinical Coordinator, 314-362-6989
Dalfampridine (AMPYRA ®) after Optic Neuritis to Improve Visual Function in Multiple Sclerosis
Location of Trial: John L. Trotter MS Center, Washington University School of Medicine
Description:
The purpose of this research study is to evaluate if a drug called Dalfampridine (Ampyra ®) may help improve vision function in 50 people with MS whose vision is known to be affected.
Participant Criteria:
18-70 years of age with a diagnosis MS and have stable optic neuritis (cannot have had optic neuritis flare up in last 12 months), no history of seizure or kidney problems and have not had any disease activity within the last 3 months
Length of Trial: 8 weeks
Clinical Trial Sponsor: Acorda Therapeutics
Contact: Samantha Lancia, Research Patient Coordinator/Professional 314-747-5576; lancias@neuro.wustl.edu
Donate Blood for Research
Dr. Laura Piccio and Dr. Anne Cross
Description: Study to identify genes important in MS development.
Participant Criteria: Any type of MS on any medication, 18 years old or older. Will be asked to sign an Informed Consent form.
Length: Patient donates blood sample one time
Sponsor: None
Contact: Laura Piccio, MD (314) 362-3306 (leave message)
West County MS Center
Other Research Opportunities
Researchers Recruiting 5,000 First-Degree Relatives of People with MS for Genetic/Environmental Research Study
Researcher from the Harvard Medical School, Brigham and Women's Hospital, and Partners Multiple Sclerosis Center are recruiting 5,000 subjects who have at least on first-degree relative with a diagnosis of MS. The goal of the study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing MS. A first-degree relative could be a parent, sibling or child of a person with MS, and the study is limited to those between 18 and 50 years of age. The GEMS (Genes and Environment in MS) study is led by primary investigator Philip De Jager, MD, PhD, a Harry Weaver Neuroscience Scholar of the National MS Society. The study is privately funded.
Background: An individual's risk of developing MS increases several-fold if a close family member has MS. There is currently no way to predict which family members will develop MS. Genetic, environmental and immunologic studies to date have identified key markers that are associated with the risk of MS. The GEMS Study is gathering genetic material (DNA) and environmental exposure history from participant as well as blood samples and brain Magnetic Resonance Imaging (MRI) as an option. Investigators are testing the performance of new method of identifying persons at risk for MS. Identifying high-risk individuals will influence the design of effective preventive strategies for MS.
The Study: Investigators are recruiting 5,000 first-degree relatives of MS patients. A first-degree relative could be a parent, sibling, or child between 18 and 50 years of age. The first-degree relative may or may not have an existing diagnosis of MS, but must have the ability to provide consent and be willing to participate in the study.
All 5,000 participants are being asked to donate a saliva sample for DNA analysis (sent via mail, at no cost to the participant) and complete a questionnaire online about neurologic history, family history and potential environmental exposures. Based on answers to this questionnaire and the DNA analysis, the team will be collecting blood samples and MRI scans from a subset of participants every three years for up to 20 years to obtain an updated questionnaire.
There is no cost to participate in the study, and participants can reside anywhere in the United States because no travel is required to enroll in the study. Some travel may be required for the optional MRI portion of the study and the participant will be reimbursed for the travel cost.
All the participants are assigned a unique study identification number to ensure complete confidentiality.
Using this information, the investigators plan to pinpoint specific genetic, environmental, and immunologic factors that may increase a person's risk of developing MS. These findings may allow for earlier intervention to slow down MS or help to develop strategies for preventing the disease.
Contact: For more information about this study, please contact
the research coordinator:
Emily Owen
Phone: (617) 264.5980
E-mail: bwhmsstudy@partners.org
Study Web site: https//dejager_lab.bwh.harvard.edu/gems.html
Facebook page: http://bitly.com/GEMSstudy
Increasing Physical Activity in Persons with Multiple Sclerosis: Functional Outcomes
Description: This study is testing the efficacy of an Internet-delivered intervention that is based on principles of social cognitive theory for increasing physical activity behavior and improving walking and cognitive function among persons with MS.
Location of Trial: The testing is based at the University of Illinois in Urbana-Champaign, but we are delivering a program for increasing physical activity through the Internet and this component occurs in the participant’s home.
Participant Criteria: The inclusion criteria involve (a) diagnosis of MS; (b) relapse free in the past 30 days; (c) Internet access; (d) willingness to complete the questionnaires and undergo walking and cognitive function testing, wear the accelerometer, and undergo randomization; (e) being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months; (f) ability to ambulate with or without assistance (i.e., walking with or without a cane or walker, but not a wheelchair); and (g) age between 18 and 64 years.
Length of Trial: The study itself is 12-months long and will consist of 2, six-month phases: (1) time of no treatment or A phase and (2) time of treatment or B phase.
Clinical Trial Sponsor: We have applied for funding from the NMSS and received a favorable score, but the money of pilot grants has been depleted. We are expecting funding in October as the fund is annually renewed.
Contact: Robert W. Motl, robmotl@illinois.edu, (217) 244-1191.
Investigators Recruiting for Study Comparing Exercise Programs to Improve Depression
Investigators at the University of Washington, Seattle, are recruiting 108 people with all types of MS or spinal cord injury nationwide for a study comparing the effects on depression of two telephone-coordinated exercise programs. The study, also called the inMotion study, is funded by the National Institutes on Disability and Rehabilitation Research.
Eligibility and Details: Participants should be at least 45 years old, have MS or spinal cord injury, and should meet the criteria for major Depressive Disorder or chronic depression.
Description: After several baseline phone calls, and wearing an accelerometer ( a device that measures physical activity, similar to a pedometer) for seven days, participants will be randomly assigned to one of two groups. In Group A, a research study counselor will help participants to develop a personalized exercise program, based on individual motivation and need. The counselor also will provide six to eight follow-up phone counseling sessions, helping participants to raise motivation, track progress, problem solve, and make changes to the exercise program as needed.
In Group B, participants will receive one 60-minute phone session during which a counselor will review how to exercise safely and provide extra information on how to find exercises that suit individual needs. No follow-up counselor calls will be made to Group B. Both groups will receive three more questionnaire calls at Weeks 6, 12, and 24 of the study period.
Participants will be reimbursed for their time and for phone expenses up to $120.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact:
The inMotion Study
University of Washington
Box 356490
Seattle, WA 98195
1.866.928.2114
agerrtc@uw.edu
Genetics Study - UCSF
Description: The UCSF MS Genetics Group is looking for participation of two types of families: single-case and multi-case families.
Participant Criteria: Participants will be asked to:
-
Fill out a family information form
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Sign a form to release medical records (people with MS only)
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Read and sign a consent and authorization form
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Donate a blood sample (about five tablespoons)
For more information:
http://www.nationalmssociety.org/research/researchers-need-you/participate-in-ms-genetic-studies/index.aspx
Contact: UCSF MS Genetics Group at 1-866-MS-GENES or 1-866-674-3637; www.neurology.ucsf.edu
Research Banks
You can make a difference by arranging in advance to donate your brain and spinal cord tissues for research. The National MS Society supports three MS tissue banks, which are storage facilities that provide tissue samples to researchers studying MS. These studies generally focus on the pathology of MS - its nature, cause, and effects on the brain - and they are extremely important. Tissue samples are preserved very soon after the death of the donor. The banked tissues are carefully catalogued with information about the each donor's clinical history.
Those interested in the possibility of tissue donation may contact these banks:
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Human Brain and Spinal Fluid Resource Center
West Los Angeles Health Care Center
Los Angeles, CA
310-268-3536 phone; 310-636-5199 (24-hour pager) -
Rocky Mountain MS Center Tissue Bank
Englewood, CO
303-788-4030 phone -
Multiple Sclerosis Tissue Repository at University of Illinois at Chicago
Chicago, IL
312-996-5763 phone