This
list contains information about trials that are recruiting
people with MS, which was provided to us by the investigators
involved. Although we try to keep this list current, it is
possible that the trials are no longer enrolling participants.
More information on trials recruiting patients is available
from the MS
Quarterly Report's
listing of Current
Clinical Trials in MS.
For
definitions and abbreviations, see the Glossary,
and see Clinical
Trial Participation for general information on enrolling
in trials. Individuals who are interested in participating in
a clinical trial are encouraged to discuss the possibility
with their personal physicians.
Please
note: To participate, you will have to reside near the
facility, as treatment and follow-up visits will be necessary
throughout the course of the study. Also, please keep in mind
that clinical trials often have strict criteria for
enrollment, specifying the type of people (disease type,
duration, age, etc.) they are seeking to participate. These
help to ensure that the results will be as reliable and as
effective as possible.
Multiple
States, Centers
Agent:
Antegren® (natalizumab)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
Multiple, international
Type
of MS: RR
Number
of Subjects: 900
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: 1-866-914-6105, active as of 4/12/02
Note:
Information on the Connecticut, Illinois and Texas sites for
this study is listed below under those locations.
Agent:
Antegren® (natalizumab) and Avonex®
(interferon beta-1a)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind study of Antegren and Avonex
versus Avonex and placebo
Institution(s):
Multiple, U.S. and Europe
Type
of MS: RR
Number
of Subjects: 1200
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: 1-866-914-6105, active as of 4/12/02
Note:
Information on the Texas site for this study is listed below
under those locations.
Agent:
Avonex
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Analysis of effects of Avonex on
cognitive symptoms
Institution(s):
Multiple, U.S.
Type
of MS: RR
Number
of Subjects: 120
Funding:
Biogen, Inc.
Enrollment
Information: msproject1@hotmail.com
Agent:
Novantrone®
(mitoxantrone for injection concentrate)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study to determine
tolerability
Institution(s):
Multiple sites
Type
of MS: Worsening RR, SP
Number
of Subjects: 500
Funding:
Immunex Corporation
Enrollment
Information: goodkind@immunex.com
Note: Information on the New York site
for this study is listed below under “New York.”
Agent:
Novantrone
and Avonex
or Copaxone®
(glatiramer acetate)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study to determine
tolerability of combining Novantrone with either Avonex or
Copaxone
Institution(s):
Multiple sites
Type
of MS: Worsening RR, SP
Number
of Subjects: 60
Funding:
Immunex Corporation
Enrollment
Information: goodkind@immunex.com
Note: Information on the New York site
for this study is listed below under “New York.”
California
Agent:
Androgel™ (testosterone gel)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study for treatment of MS
Institution(s):
University of California, Los Angeles
Type
of MS: Definite RR or SP, with at least 1 relapse in 2 years
prior to entry in study
Number
of Subjects: 12 males
Funding:
none
Enrollment
Information: Ricki Klutch, RN, rklutch@ucla.edu
Agent:
Avonex
Treatment
Mode of Action: To reduce self-injection anxiety
Study
Description/Purpose: Blinded study to determine effectiveness
of brief cognitive behavioral intervention to treat
self-injection anxiety in people taking Avonex.
Institution(s):
University of California, San Francisco
Type
of MS: RR
Number
of Subjects: 40
Funding:
Biogen, Inc.
Enrollment
Information: Darcy Cox, PsyD, (415) 221-4810, ext. 4962, http://mscenter.ucsf.edu/research.htm
Connecticut
Agent:
Antegren® (natalizumab)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
Yale MS Research Center, New Haven, and others, international
Type
of MS: RR
Number
of Subjects: 10-20
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: Jonas Anderson, (203)
764-4285
or jonas.anderson@yale.edu
Note:
This is one site of a worldwide study. Contact information for
other sites is listed above under “Multiple States,
Centers.”
Agent:
CNTO 1275, a human monoclonal antibody
Treatment
Mode of Action: To
affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study
for treatment of MS
Institution:
Yale MS Research Center, New Haven.
Number
of Subjects: Not available
Funding:
Centocor, Inc.
Enrollment
Information: Jonas Anderson, (203) 764-4285 or
jonas.anderson@yale.edu
Agent:
Investigational drug (molecule that regulates immune
response), name of drug not released
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
Yale MS Research Center, New Haven, and others, international
Type
of MS: RR
Number
of Subjects: not available
Funding:
Bristol-Myers Squibb Company
Enrollment
Information: Jonas Anderson, (203) 764-4285
or jonas.anderson@yale.edu
Note:
This is one site of a worldwide study. Contact information for
other sites is listed under Canada, Pennsylvania,
and Texas.
Agent:
Novantrone
Treatment
Mode of Action: To affect immune function
Study Description/Purpose: Five-year
study of tolerability and safety monitoring for open-label
Novantrone infusions.
Institution(s):
Yale
University School of Medicine, New Haven, CT
Type
of MS: worsening RR, SP, PR
Number
of Subjects: 20
Funding:
Immunex Corporation
Enrollment
Information: Jonas Anderson, (203) 764-4285
Note:
This is one site of a nationwide study. Contact information
for other sites is listed above under “Multiple States,
Centers.”
Agent:
Novantrone
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Prospective study of quality of life and
cost of disease in people with MS treated with Novantrone.
Institution(s):
Yale University School of Medicine, New Haven, CT
Type
of MS: Worsening RR, SP
Number
of Subjects: NA
Funding:
Immunex
Enrollment
Information: Debbie.Ruotolo@yale.edu
Agent:
Schwann cell (myelin-making cells from peripheral nervous
system) transplantation
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Blinded study of safety and effectiveness
Institution(s):
Yale MS Research Center, New Haven
Type
of MS: SP
Number
of Subjects: 5
Funding:
The Myelin Project
Enrollment
Information: msresearch@yale.edu
Illinois
Agent:
Antegren® (natalizumab)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
University of Chicago and
others, international
Type
of MS: RR
Number
of Subjects: 20
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: Barbara
Harding-Clay CMA, CCRC
(773)834-4654
Note:
This is one site of a worldwide study. Contact information for
other sites is listed above under “Multiple States,
Centers.”
Maine
Agent:
IDEC-131 (anti-CD40L
or anti-CD154, molecule
that regulates immune response)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-control study for
treatment of MS
Institution(s):
Dartmouth Medical School, Hanover, NH
Type
of MS: RR
Number
of Subjects: 40-48
Funding:
Immune Tolerance Network, National Institute of Neurological
Disorders and Stroke
Enrollment
Information: kathleen.ryan@dartmouth.edu
Maryland
Agent:
Betaseron®
(interferon beta 1-b) and Imuran®
(azathioprine)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study of safety and
effectiveness of combination therapy
Institution(s):
University of Maryland, Baltimore, and others
Type
of MS: RR, SP
Number
of Subjects: 18
Funding:
Berlex Laboratories, Inc.
Enrollment
Information: pcala001@umaryland.edu
Agent:
Novantrone
and either Avonex
or Copaxone
Treatment
Mode of Action: Immunosuppressive and Immunomodulatory
Study
Description/Purpose: Open-label study to determine safety and
effectiveness
Institution(s):
University of Maryland, Baltimore, and others
Type
of MS: Worsening RR, SP
Number
of Subjects: 50
Funding:
Investigator sponsored, financial support from Immunex
Enrollment
Information: Kerry Naunton, RN, (410) 328-1155
Note: This is one site of a nationwide
study. Contact information for other sites is listed above
under “Multiple States, Centers.”
Massachusetts
Agent:
Copaxone
and Proventil® (albuterol)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness.
Institution(s):
Brigham and Women's Hospital MS Center, Boston
Type
of MS: RR
Number
of Subjects: 40
Funding:
National Institutes of Health, National Institute of Allergy
and Infectious Disease, Autoimmunity Centers of Excellence
Enrollment
Information: malbano@partners.org
Agent:
IDEC-131 (anti-CD40L
or anti-CD154, molecule
that regulates immune response)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-control study for
treatment of MS
Institution(s):
Dartmouth Medical School, Hanover, NH
Type
of MS: RR
Number
of Subjects: 40-48
Funding:
Immune Tolerance Network, National Institute of Neurological
Disorders and Stroke
Enrollment
Information: kathleen.ryan@dartmouth.edu
Michigan
Agent:
Rebif®
(interferon beta-1a), Rebiject™ Mini (autoinjector
device)
Treatment
mode of action: To affect immune function
Study
description: Open-label study comparing the tolerability of
Rebif injections with and without the use of Rebiject™ Mini
in people with relapsing-remitting MS.
Institution:
University of Michigan, Ann Arbor, and others
Type
of MS: RR
Number
of subjects: No limit
Funding:
Serono S.A.
Enrollment
information: dmiko@umich.edu
Agent:
CellCept® (mycophenolate
mofetil, an oral immune suppressant currently used to prevent
rejection of organ transplants)
and Betaseron®
(interferon beta 1-b)
Treatment
mode of action: To affect immune function
Study
description: Open label, randomized, placebo-controlled study,
addressing the effectiveness of the combined therapy in MS
patients.
Institution:
University of Michigan, Ann Arbor
Type
of MS: RR
Number
of subjects: 30
Funding:
Berlex
Enrollment
information: dmiko@umich.edu
Missouri
Agent:
Trimethoprim (antibiotic therapy) and vitamin C
Treatment
Mode of Action: To prevent MS relapse with bladder care
Study
Description/Purpose: Double-blind, placebo-control study to
compare the number of MS relapses in people who receive a
bladder infection suppressant versus those who receive placebo
and routine bladder care
Institution(s):
Washington University, St. Louis
Type
of MS: RR, SP
Number
of Subjects: 100
females
Funding:
National MS Society
Enrollment
Information: lauberj@neuro.wustl.edu
Agent:
Avonex
and intravenous high dose methotrexate
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study of safety and
effectiveness of combination therapy
Institution(s):
Consultants in Neurology and MidAmerican Neuroscience
Institute, Kansas City
Type
of MS: worsening RR, and SP
Number
of Subjects: 15
Funding:
Biogen, Inc.
Enrollment
Information: Ldressman@cinpc.com
Agent:
Rituxan® (rituximab, molecule that regulates immune response)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study for treatment of MS
Institution(s):
Washington University, St. Louis
Type
of MS: RR
Number
of Subjects: 30
subjects
Funding:
National MS Society
Enrollment
Information: lauberj@neuro.wustl.edu
Nebraska
Agent: Avonex
and pain medication (Tylenol® [acetaminophen], Advil®
[ibuprofen] or Aleve® [naproxen])
Treatment
Mode of Action: To reduce side effects
Study
Description/Purpose: Open-label, randomized study of the use
of over-the-counter pain medications to minimize side effects
in two groups, those initiating Avonex therapy and those who
continue to exhibit side effects after six months on Avonex
Institution(s):
University of Nebraska Medical Center, Omaha
Type
of MS: RR
Number
of Subjects: 90
Funding:
Biogen, Inc.
Enrollment
Information: M. Patricia Leuschen, PhD, pleusche@unmc.edu
New Hampshire
Agent:
IDEC-131 (anti-CD40L
or anti-CD154, molecule
that regulates immune response)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-control study for
treatment of MS
Institution(s):
Dartmouth Medical School, Hanover
Type
of MS: RR
Number
of Subjects: 40-48
Funding:
Immune Tolerance Network, National Institute of Neurological
Disorders and Stroke
Enrollment
Information: kathleen.ryan@dartmouth.edu
New York
Agent:
Avonex
and Prozac®
(fluoxetine)
Treatment
Mode of Action: To affect immune function and improve symptoms
Study
Description/Purpose: Double-blind study to compare the safety
and effectiveness of Avonex and Prozac versus Avonex and
placebo.
Institution(s):
Upstate Clinical Research, LLC, Albany, NY
Type
of MS: RR
Number
of Subjects: 20
Funding:
Biogen, Inc.
Enrollment
Information: Suzanne Alterman, RN, (518) 533-1500, ext. 546
Agent:
Copaxone
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study comparing effectiveness
in people who have never been treated with Copaxone and people
who have not responded to interferon therapy
Institution(s):
Mount Sinai School of Medicine, Corinne Goldsmith
Dickinson Center for MS, New York City, and others
Type
of MS: RR
Number
of Subjects: 120
Funding:
Teva Marion Partners
Enrollment Information:
Michele Weber, (212) 241-4264, or multiple.sclerosis@mssm.edu
Agent:
Novantrone
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Five-year study of tolerability and
safety monitoring for open-label Novantrone infusions.
Institution(s):
Mount Sinai School of Medicine, Corinne Goldsmith Dickinson
Center for MS, New York City
Type
of MS: RR, SP
Number
of Subjects: 10
Funding:
Immunex Corporation
Enrollment
Information: Michele Weber, (212) 241-4264, or multiple.sclerosis@mssm.edu
Note: This is one site of a nationwide
study. Contact information for other sites is listed above
under “Multiple States, Centers.”
Agent:
Novantrone
and Avonex
or Copaxone
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study to determine
tolerability of combining Novantrone with either Avonex or
Copaxone
Institution(s):
Mount Sinai School of Medicine, Corinne Goldsmith
Dickinson Center for MS, New York City
Type
of MS: Clinically Definite
Number
of Subjects: 15
Funding:
Immunex Corporation
Enrollment
Information: Michele Weber, (212) 241-4264, or multiple.sclerosis@mssm.edu
Note: This is one site of a nationwide
study. Contact information for other sites is listed above
under “Multiple States, Centers.”
Ohio
Agent:
intensive outpatient rehabilitation
Treatment
Mode of Action: To improve symptoms following acute relapses
of MS
Study
Description/Purpose: Blinded, controlled study to determine
effectiveness of physical and occupational therapy following
acute relapses of MS
Institution(s):
Mellen Center for Multiple Sclerosis Treatment and Research,
Cleveland Clinic Foundation, Cleveland
Type
of MS: RR and SP, following acute relapses
Number
of Subjects: 160
Funding:
National MS Society
Enrollment
Information: ivancid@ccf.org
Pennsylvania
Agent:
Avonex
and Imuran
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study to determine safety and
effectiveness
Institution(s):
Lehigh Valley Hospital, Allentown, PA
Type
of MS: RR
Number
of Subjects: NA
Funding:
Biogen, Inc.
Enrollment
Information: Nancy Eckert, RN, (610) 402-9001, nancy.eckert@lvh.com
Agent:
Inosine (dietary supplement in oral capsule form)
Treatment
mode of action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine
safety and efficacy of inosine, and effect of inosine on the
number
of newly active lesions.
Institution:
University of Pennsylvania, Philadelphia
Type
of MS: RR
Number
of subjects: 30 subjects
Funding:
Thomas Jefferson University
Enrollment
Information: Tara Ordille, (215) 662-4893
Agent:
Investigational drug (molecule that regulates immune
response), name of drug not released
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine
safety and effectiveness
Institution(s):
The University of Pennsylvania, The Hospital of the
University
of Pennsylvania-Department of Neurology, and others,
international
Type
of MS: RR
Number
of Subjects: 6
Funding:
Bristol-Myers Squibb Company
Enrollment
Information: Tara Ordille (215) 662-4893
Note:
This is one site of a worldwide study. Contact information for
other
sites
is listed under Canada, Connecticut and Texas.
South
Carolina
Agent:
Zocor® (simvastatin), a cholesterol-lowering drug under study
for treatment of MS
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Open-label study to determine
effectiveness
Institution(s):
Medical University of South Carolina, Charleston, and
others
Type
of MS: RR
Number
of Subjects: not available
Funding:
Merck, Inc.
Enrollment
Information: Feng Liu, phone - (843) 792-2993, fax - (843)
792-8626, liuf@musc.edu
Texas
Agent:
Antegren® (natalizumab)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
Texas Neurology, PA, Dallas, and others, international
Type
of MS: RR
Number
of Subjects: 900
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: Janey Phillips, (214) 827-3610, ext. 258
Note:
This is one site of a nationwide study. Contact information
for other sites is listed above under “Multiple States,
Centers.”
Agent:
Antegren® (natalizumab) and Avonex
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind study of Antegren and Avonex
versus Avonex and placebo
Institution(s):
Texas Neurology, PA, Dallas, and others, U.S. and Europe
Type
of MS: RR
Number
of Subjects: 1200
Funding:
Biogen, Inc., Elan Corporation plc
Enrollment
Information: Janey Phillips, (214) 827-3610, ext. 258
Note:
This is one site of a worldwide study. Contact information for
other sites is listed above under “Multiple States,
Centers.”
Agent:
Investigational drug (molecule that regulates immune
response), name of drug not released
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
Texas Neurology, PA, Dallas, and others, international
Type
of MS: RR
Number
of Subjects: 330
Funding:
Bristol-Myers Squibb Company
Enrollment
Information: Janey Phillips, (214) 827-3610, ext. 258
Note:
This is one site of a worldwide study. Contact information for
other sites is listed under Canada and Italy.
Vermont
Agent:
IDEC-131 (anti-CD40L
or anti-CD154, molecule
that regulates immune response)
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-control study for
treatment of MS
Institution(s):
Dartmouth Medical School, Hanover, NH
Type
of MS: RR
Number
of Subjects: 46-50
Funding:
Immune Tolerance Network, National Institute of Neurological
Disorders and Stroke
Enrollment
Information: kathleen.ryan@dartmouth.edu
Virginia
Agent:
Avonex
Treatment
Mode of Action: To improve attention and concentration
deficits
Study
Description/Purpose: Open-label study to determine effects of
attention and concentration in patients diagnosed with
relapsing-remitting MS, receiving initial treatment with
Avonex
Institution(s):
Neuroscience Consultants, PLC, Reston, VA
Type
of MS: RR
Number
of Subjects: 15
Funding:
Biogen, Inc.
Enrollment
Information: sparlow@nscplc.com
International
Canada
Agent:
Investigational drug (molecule that regulates immune
response), name of drug not released
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind, placebo-controlled study to
determine safety and effectiveness
Institution(s):
University of Toronto, CANADA, and others, international
Type
of MS: RR
Number
of Subjects: 330
Funding:
Bristol-Myers Squibb Company
Enrollment
Information: (416) 864-5206
Note:
This is one site of a worldwide study. Contact information for
other sites is listed under Connecticut, Pennsylvania, and
Texas.
France
Agent:
3-4 diaminopyridine
Treatment
Mode of Action: To improve fatigue
Study
Description/Purpose: Double-blind, placebo controlled study to
determine safety and effectiveness
Institution(s):
CHU de Rennes, FRANCE
Type
of MS: All types
Number
of Subjects: 60
Funding:
French Health Ministry
Enrollment
Information: gilles.edan@chu-rennes.fr
Agent:
Novantrone
and Betaseron
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind study to determine safety
and effectiveness
Institution(s):
CHU de Rennes, FRANCE, and
others in France and Italy
Type
of MS: RR
Number
of Subjects: 124
Funding:
French Health Ministry, Schering AG
Enrollment
Information: gilles.edan@chu-rennes.fr
Israel
Agent:
T cell vaccination
Treatment
Mode of Action: To affect immune function
Study
Description/Purpose: Double-blind study to determine safety
and effectiveness
Institution(s):
Hadassah Hospital, Jerusalem, ISRAEL
Type
of MS: RR
Number
of Subjects: 30
Funding:
Grant for TCV
Enrollment
Information: Dr. Dimitrios Karussis, karus@cc.huji.ac.il
Italy
Agent:
computer-assisted cognitive rehabilitation
Treatment
Mode of Action: To improve memory, attention
Study
Description/Purpose: Randomized, double-blind study
Institution(s):
Multiple sites
Type
of MS: all
Number
of Subjects: 120
Funding:
National MS Society
Enrollment
Information: Alessandra
Solari, MD, solari@istituto-esta.it
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