Research is alive and well on Long Island. The MS Care Centers are involved in numerous clinical trials to further advances in MS therapies. Here is a sample of what is being done.
COMBI RX Study - This is a combination study using Copaxone and Avonex in RRMS patients who have recently been diagnosed with RRMS (relapsing remitting multiple sclerosis) and have never been on any medication to treat their MS (other than steroids).
CONFIRM Study - This is an oral agent BG12 being used to treat MS patients. Patients between the ages of 18 - 55 years old diagnosed with RRMS, who have never been on Copaxone, who could have been on other medications, but are not at this time. These studies are currently being conducted at the Multiple Sclerosis Treatment Canter at Winthrop University and The Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates PC.
TYGRIS Study - Patients starting on Tysabri are eligible to enroll in the TYGRIS Program after their first dose of Tysabri and before their 4th dose of Tysabri. This is a further safety study which will follow these patients for a total of 5 years to monitor safety.
BRAVO Study - This study is designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex. The BRAVO trial aims to enroll patients with relapsing-remitting multiple sclerosis (RRMS).
For more information please contact:
Winthrop
Kim Byrnes (516) 663-9582
South Shore Neurological Associates PC
Lori Fafard or Laura Graffitti (631) 758-1910 ext. 2187
Five Towns Neuroscience Research
Cheryl Casale (516) 239-1800
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The Multiple Sclerosis Treatment Center in conjunction with Winthrop University Hospital Clinical Trials Center offers patients with Multiple Sclerosis the opportunity to participate in various medical research studies.
Dr. Malcolm Gottesman, Director of the MS Treatment Program and the Chief of Neurology at Winthrop University Hospital is currently enrolling eligible study participants in the following programs:
CARE-MS II: This study compares Alemtuzumab and Rebif®. This study is designed to determine the safety and effectiveness of the investigational drug Alemtuzumab as compared to the FDA-approved therapy Rebif in adults aged 18-55, with Relapsing Remitting MS.
MS Trial Alert: Small Study Recruiting People with MS and Spasticity to Compare IPX056 (Extended-release Baclofen) and Immediate-release Baclofen
Summary: Investigators at seven sites in the United States are recruiting 28 people for a study comparing the effect of the experimental compound IPX056 (extended-release baclofen) to currently available, immediate-release baclofen in relieving spasticity and symptoms related to MS. The study is sponsored by Impax Pharmaceuticals, a division of Impax Laboratories, Inc.
Rationale: Spasticity refers to feelings of stiffness and a wide range of involuntary muscle spasms (sustained muscle contractions or sudden movements). It is one of the more common and troublesome symptoms of MS. Baclofen acts on the central nervous system to relieve spasms, cramping, and tightness of muscles caused by spasticity. This study is comparing IPX056, a new extended-release form of baclofen, to the currently available immediate-release baclofen tablets. Extended release – in which a drug is released over time – may allow for it to be taken less often. In a previous study that enrolled 173 people with MS, IPX056 significantly reduced spasticity when compared with placebo, according to a company press release dated August 7, 2008. Impax was requested to collect additional data on the safety and effectiveness of IPX056 by the U.S. Food and Drug Administration, according to a December 11, 2008 press release.
Eligibility and Details: Participants should be at least 18 years old, with MS, and have been taking baclofen tablets three times daily (15 mg to 80 mg total daily dose) for at least 4 weeks, with resulting improvements in spasticity.
Participants will take individually adjusted doses of either IPX056 twice a day or immediate-release baclofen three times a day for six weeks. The primary endpoints being evaluated are scores on scales measuring morning stiffness and nighttime awakening.
All eligible participants will receive study - related medication and medical care at no cost. We are seeking answers to scientific questions; however, patient safety is our primary concern.
Please feel free to contact, Research Coordinator, Kim Byrnes at 516-663-9582 to discuss new therapies.
To learn more about Clinical Trials, please consult the Research page of this website.