Tuesday, January 22, 2008

Current Clinical Trials in MS–Open For Enrollment


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Current Clinical Trials in MS–Open For Enrollment

A Longitudinal, Case-Control Study to Collect Medical and Epidemiological Data and Blood Samples for Research Into the Causes of MS and Selected Demyelinating Diseases

Location: Barrow Neurology Clinics at St. Joseph’s Hospital & Medical Center in Phoenix, AZ.

Purpose: This research study is being done to establish a large-scale, multidisciplinary blood and data bank that will be made available to scientists involved in the study of MS and other demyelinating diseases and, in particular, what causes these diseases. The bank will include a collection of blood and associated data from two groups (Cases and Controls)


Inclusion Criteria:

Cases & Controls:

• At least 18 years of age.

• Individuals who have experienced at least one central nervous system (CNS) demyelinating event characteristic of multiple sclerosis (MS), transverse myelitis ™, acute disseminated encephalomyelitis (ADEM), neuromyelitis optica (NMO) or optic neuritis (ON).

• Individuals who have not experienced any CNS demyelinating events characteristic of MS, TM, ADEM, NMO or ON and have not been diagnosed with any demyelinating disease.

Exclusion Criteria:

Cases & Controls:
• Individuals with clinical or radiological evidence of stroke, meningitis, neoplastic, peripheral nervous system or primary muscle disease, or other well characterized and defined diseases of the nervous system with the exception of MS, TM, ADEM, NMO, ON.
• Individuals with a history of blood borne pathogens (e.g., viral hepatitis, HIV/AIDS).
• Individuals with a history of allogeneic bone marrow transplant due.

Patients who are determined to be eligible will complete an initial visit and followup visits every one to two years for the remainder of their lifespan. Additionally, they will be asked to refer blood related family members with and without MS, TM, ADEM, NMO or ON, as well as unrelated controls, to the study. The relatives and unrelated controls will then have the option to contact the research team in order to be screened. A familial link will be maintained between all family members participating in the study.

Benefit: Patients will not benefit directly by participating in this research. The studies that may be performed with their data and specimens will not be designed to specifically help them and will not be used to make health care decisions for them. However, the knowledge gained from the studies may benefit others in the future.

For Information: Contact Taira Kochar, research coordinator, at 602-406-7711.

A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study, to Compare the Efficacy,Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With RRMS

Location: Barrow Neurology Clinics at St. Joseph’s Hospital & Medical Center in Phoenix, AZ

Purpose: The purpose of this research study is to determine whether or not a higher 40 mg dose of glatiramer acetate (Copaxone®) is safe and more effective in treating multiple sclerosis (MS) than the currently available 20 mg dose of glatiramer acetate.


Inclusion Criteria:
• 18 to 55 years of age
• RRMS with at least one documented relapse in the 12 months prior to screening and at least two documented
relapses in the 24 months prior to screening
• Relapse free and in stable neurological condition at least 30 days prior to screening

Exclusion Criteria:
• No previous use of GA
• No previous use of Natalizumab
• No IVIG or interferons within 2 months
• No steroids within 30 days
• No chronic use of steroids within 6 months
• No immunosuppressants within 6 months

Procedure: Patients who are determined to be eligible will be randomized to receive either glatiramer acetate (GA) 20 mg or GA 40 mg for the first twelve months of the study. For the second half of the study (Months 12 through 24), all patients in the study will receive GA 40 mg. Patients will come to the MS Research Office at Barrow Neurology Clinics for 12 scheduled visits over approximately 2 years. In addition, some patients may have additional scheduled visits. Study visits will include the following: physical and neurological examinations, MRIs, ECGs and laboratory tests.

Benefit: It is hoped that patients taking the 40 mg dose will do better with their multiple sclerosis (MS) than patients taking the 20 mg dose. During the course of this study, a patient’s MS may improve, remain the same or worsen.

For Information: Contact Mary Catherine Parker, RN, research coordinator, at 602-406-7711.

Achieve Study––Assessing Copaxone®Versus High Dose Interferon—Evaluation of Efficacy

Location: Multi-centers throughout the US and Canada.

Purpose: A phase IV study to compare the total number of relapses experienced by patients randomized to maintain treatment on high-dose INF therapy compared to those who were transferred to Copaxone® (glatiramer acetate) in patients with relapsing MS.

• Men and women ages 18–50
• Diagnosis of clinically definite MS with a relapsing disease course
• Must be on either Rebif® or Betaseron® for a minimum of 1 year prior to
study entry
• Relapse history to meet the eligibility criteria of the study.

• Participants will receive injections of either INF or Copaxone for 3 years
• MRIs will be performed every 6 months for the duration of the study.

Benefit: Primary outcome will be the analysis of the difference in relapse rate between the two groups of patients.

For Information: Please call 1-866-550-0614 or go to www.centerwatch.com or www.nationalmssociety.org

Biogen IDEC Trial: Multi-Centered, Open Label Study of Approximately 300 Relapsing MS Patients That Will Compare B-IFN Induced Biomarker Response Following B-IFN Injection In Neutralizing Antibody Positive vs. Antibody Negative Patients

Location: Phoenix, AZ.

Purpose: To compare baseline B-IFN induced MxA mRNA response in neutralizing antibody positive vs. antibody negative patients.

Eligibility: Patients must currently be treated with the same interferon for 12–48 months. Patients must be 18–65. Patients must not have had prior testing for neutralizing antibodies. Patients can not be on combination therapies.

Procedure: 6-month study with three clinic visits and three blood draws at Barrow Neurology Clinics located at St. Joseph’s Hospital in Phoenix, AZ.

For Information: Mary Catherine Parker, RN, CCRC, at 602- 406-6287 or email mary.parker@chw.edu

CombiRx Phase 3 (NIH-NINDS # 1 U01 NS 45719-01 A1)

Location: 85 sites in the US and Canada.

Purpose: National Institutes of Health sponsored, multi-center, double-blind, randomized study comparing the combined use of Interferon Beta-1a and Glatiramer Acetate to either agent alone in patients with relapsing-remitting multiple sclerosis.

Eligibility: Men and women 18–60 years of age with relapsing-remitting MS who have experienced at least two relapses in the previous three years and have never taken either Glatiramer Acetate or Interferon Beta-1a.

Procedure: The subject’s duration in the study will be 36 months. Upon enrollment, subjects will begin simultaneously on two medications—all subjects will receive at least one active medication. There is no placeboonly group.
• Interferon Beta-1a intramuscular (IM) weekly and subcutaneous (SQ) placebo daily (25% of group)
• Glatiramer Acetate SQ daily and IM placebo weekly (25% of group)
• Interferon Beta-1a IM weekly and Glatiramer Acetate SQ daily (50% of group)

Benefit:The primary objective of this study is to determine whether combined treatment with Interferon Beta-1a IM once weekly and Glatiramer Acetate SQ daily is more effective than either agent alone in treating Relapsing-Remitting MS as determined by reduction in relapse rate. Study drug and all study specific evaluations are provided at no cost to subjects. Parking or reimbursement for transportation will be provided for up to $20 with a receipt.

For Information:
• Call toll free 1-866-848-3088
• If you are within 50 miles of West Los Angeles, CA, Call Dr. Baumhefner at (310)-268-3013
• MS Care Center, Hospital for Joint Diseases, New York, NY. Call Tamar Fromm at 212-598-6585
• Barrow Neurological Institute, Phoenix, AZ. Call Oana Sebescu at 602-406-6291
• Mt. Sinai School of Medicine, New York, NY. Call 866-848-3058

Combination Therapy Trial for RRMS

Teva Neuroscience, Inc., is conducting a clinical trial to evaluate whether a combination therapy accelerates and enhances the effectiveness over conventional therapy for patients with relapsing-remitting multiple sclerosis (RRMS).

Protocol #: NC-100

Location: Multi-centers throughout the US.

Eligibility: Definite diagnosis of RRMS; males and females between the ages of 18 and 55 years old; steroid treatment-free for at least 28 days; ability to participate in study for 15 months; ability to undergo MRI scans of the brain.

For Information:
• MS Hub Medical Group, Seattle, WA—contact Tim Monahan at 206-262-0110 ext. 110

Improving Memory in Patients With MS

Location: University Hospital and Medical Center, Stony Brook, NY; Rochester, NY; Buffalo, NY; Rhode Island.

Purpose: This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept®) has been FDA-approved for improving memory and learning in individuals with Alzheimer’s disease.

Eligibility: Women and men, 18–56 years of age, with unequivocal diagnosis of MS, Expanded Disability Status Scale (EDSS) score of 0 to 6.5, stable neurologic function for at least 30 days prior to study entry, who agree to continue all current medications for study duration, and have Rey Auditory Verbal Learning Test score in the low normal range or below.

Procedure: Patients meeting the above criteria will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24-week period.

Benefit: This study may lead to new therapy to enhance the verbal memory function in individuals with MS.

For Information: Call Patricia Melville, RN, at the University Hospital and Medical Center in Stony Brook, New York, at 631-444-8164, or via e-mail: patricia.melville@stonybrook.edu

Randomized, Double Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin (Lipitor®) in Patients With Clinically Isolated Syndromes and High Risk of Conversion to MS

Location: Phoenix, AZ.

Purpose: To determine if atorvastatin is effective in relapsing-remitting MS.

• Men and women ages 18–50
• No previous neurological history
• Never been on immunological therapy for MS.

Procedure: Phase II randomized, double blind, placebo-controlled clinical trial. A 3:2 randomization of drug to placebo. Patients not on placebo will take 80 mg/day of atorvastatin.

Benefit: May lead to a new treatment for MS.

For Information: If you live within a 50-mile radius of Phoenix, AZ, contact research coordinators at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center by phone at 602-406-7711.

Stem Cell Therapy for Patients With MS Failing Interferon A Randomized Study

MS is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e., interferon, copaxone, or mitoxantrone) in patients with inflammatory (relapsing) MS despite treatment with interferon.


Inclusion Criteria:
1. Age between 18–55, inclusive
2. Diagnosis of MS using Poser criteria of “clinically definite” MS
3. An EDSS of 2.0 to 6.0
4. Inflammatory disease despite primary disease modifying therapy with at least 4 months of interferon. Inflammatory disease is defined by either MRI showing gadolinium enhancing lesions or clinically as acute relapses treated with IV solumedrol. Failure is defined as two or more clinical relapses with documented neurological changes within one year prior to the study. (Note: Relapses must have required treatment with corticosteroids). Failure may also be defined as one relapse within the year prior to the study if there is evidence on MRI of active inflammation (i.e., gadolinium enhancement)

Exclusion Criteria:
1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.

2. Prior therapy with mitoxantrone.

3. Prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix. Other malignancies for which the patient is judged to be cured, such as head and neck cancer, or breast cancer will be considered on an individual basis.

4. Positive pregnancy test.

5. Inability or unwillingness to pursue effective means of birth control. Effective birth control is defines as 1) refraining from all acts of vaginal intercourse (Abstinence); 2) consistent use of birth control pills; 3) injectable birth control methods (Depo Provera, Norplant); 4) tubal sterilization or male who has undergone vasectomy; 5) placement of an IUD (intrauterine devise); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam.

6. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.

7. FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary).

8. DLCO < 50% of predicted.

9. Resting LVEF < 50%.

10. Bilirubin> 2.0mg/dl.

11. Serum Creatinine> 2.0 mg/dl

12. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to iron compounds/medications.

13. Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams.

14. Diagnosis of primary progressive MS.

15. Platelet count < 100,000/ul, WBC < 1,500 cells/mm3.

16. Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible.

17. Active infection except asymptomatic bacteruria.

Procedure/Benefit: To compare the clinical outcomes for patients treated with standard therapy (including interferons, steroids, IVIG and chemotherapy), vs. those who undergo stem cell transplantation.

Contact Information: Kathleen Quigley, RN, BSN, MBA, phone: 312-908-0059

Treatment of MS Using Over-the-Counter Inosine

Location: Hospital of the University of Pennsylvania, Philadelphia, PA.

Purpose: The purpose of this study is to determine whether raising low levels of the natural antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic effect on the progression of RRMS and secondary progressive MS.

Eligibility: Males and females, 18–60 years of age. Non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test result within 60 days before the first dose of study material. Males and females must practice adequate contraception, in the judgment of the investigator, during the course of the study. Subjects must have a diagnosis of clinically definite relapse-remitting MS based on medical history, physical examination, laboratory test results, and neurologic examination, and have had one clinical relapse in the last year. Alternatively, subjects may have clinically probable MS characterized by one attack and the presence of at least four lesions on MRI within 12 months before the initial baseline evaluation. Subjects must have an EDSS test result of less than or equal to 5.0 within 60 days before the first dose of study material. Subjects will have serum uric acid levels less than 5 mg/dl. There are also several exclusion criteria.

For Information: Contact Vanessa Zimmerman by phone at 215-349-5162, or via e-mail: vanessa.zimmerman@uphs.upenn.edu

Zenapax® to Treat MS

Location: National study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), based in Bethesda, MD.

Protocol #:04N0019

Purpose: To examine the safety and effectiveness of Zenapax (a laboratorymanufactured antibody) in treating MS.

• Women and men aged 18–65 years
• Persons with relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment
• EDSS score between 2.5 and 6.5, inclusive
• Have failed standard IFN-beta therapy
• Must have at least two Gd-enhancing lesions or greater in the three pre-treatment MRI scans (an average of at least 0.67 Gd enhancing lesions per scan).

Procedures: Three MRI scans over initial 2 months to evaluate disease activity. During treatment, receive seven IV infusions of Zenapax––the first two will be given 2 weeks apart; the next five will be given once a month. Before each infusion, participants will have two MRI scans, one using standard procedure and one using gadolinium. Blood and urine samples will be taken at each visit. There will be skin tests. A lumbar puncture will be done at the beginning and at end of the treatment phase. Lymphocytes will be collected before, during, and after treatment.

Benefit: May lead to a new treatment for RRMS or SPMS.

For Information: Contact the NIH Patient Recruitment and Public Liaison Office, via toll-free telephone at 800-411-1222, or via e-mail: prpl@mail.cc.nih.gov

This entry was posted on Wednesday, November 15th, 2006 at 8:43 am and is filed under All Articles, Clinical Trials, Clinical Issues. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.

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