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Listed below are the clinical trials and ongoing research
being conducted at our practice. If you wish to enroll for any of these studies or have any questions about the studies, please
call our office at 518-785-1000.
Coming Soon:
1.The Ascend Study: " A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Efficacy of Natalizumab
on reducing disability progression in subjects with Secondary Progressive MS".
2. Ocralizumab
Opera Study : " A Randomized, Double-Blind, Double Dummy, Parallel group study to Evaluate
the Efficacy and Safety of Ocralizumab in Comparison to Interferon Beta-1a (Rebif ) in patients with Relapsing Multiple Sclerosis"
Currently Enrolling:
1. Oral Fingolimod Trial EPOC Study ( Novartis Pharmaceuticals Corporation)
- A 6- month, randomized, Active Comparator, Open-Label, Multi-center study to evaluate Patient outcomes, safety
and tolerability of Fingolimod (FTY720) 0.5mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates
for MS therapy change from Previous Disease Modifying Therapy.
2. Safer Monitoring For Tysabri Patients - New
Tools To Watch For PML
MS Center of Northeastern NY of Empire Neurology is
taking part in two new studies for monitoring the safety of TYSABRI.
(a) STRATIFY-2 STUDY: The Stratify-2
study will test multiple sclerosis (MS) patients to determine if they have a specific antibody in their blood against the
JC virus (JCV). The purpose of the STRATIFY-2 is to gather more information about MS patients being treated with TYSABRI or
who are considering Tysabri have the JCV antibody in their blood or not. This will allow better understanding whether antibodies
to JCV may be used to predict whether a patient is at a higher or lower risk for developing PML.
Who may participate
in the STRATIFY-2 study: MS patients in the TOUCH program may participate in this study.
(b) RESTORE
STUDY: This study is an organized withdrawal for 6 months from Tysabri for patients on Tysabri for more than 12 months.
It is a randomized study where 1/4 of patients stay on Tysabri, 1/4 go off Tysabri and 1/2 go on other medications. Patients
get monthly MRI and blood tests. No one knows if 6 months withdrawl from Tysabri increase risk of PML or not. This study will
scientifically analyze this question. Antibodies, cytokines and other markers for disease activity will be monitored.
Who
may participate in the RESTORE study: Only MS patients in the TOUCH program who have completed 12+ months on Tysabri
treatment may participate in this study.
For more information about these studies, please call our office
at (518) 785-1000 and ask for our study coordinators Judy Button or Judy O'Connor.
3. Clinical Study using Oral Drug in Patients
with Relapsing Remitting Multiple Sclerosis (RRMS)
MS Center of Northeastern NY of Empire Neurology is
taking part in a research program for the development of an oral drug for disease modification for patients with Relapsing
Remitting Multiple Sclerosis. Attached is the advertisement for the trial and links to the clinical.gov site for study details.
Click here for more Information:
4. 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 Relapsing-Remitting Multiple Sclerosis ( 205MS301 - Biogen Idec)
Click here for more information
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Clinical Trials In Alzheimer's Disease:
Empire
Neurology continues to participate in the diagnosis and management of memory disorders, especially Alzheimer’s Disease.
As reported in the New York Times front page articles on Saturday, July 17th recently, early
treatment may make a real difference.
Click here for NY Times article
The New York Times article entitled:
Drug Trials Test Bold Plan to Slow Alzheimer’s has been a goal for many years. Now at Empire Neurology, 2 drug
trials are on-going designed to reduce the burden of amyloid plaque in the brain. Amyloid plaques has been known since
the time of Dr. Alzheimer himself to be a basic part of the Alzheimer’s process. Finally, there is hope that,
in addition to standard medications such as Aricept, Exelon and Namenda, there may be treatments that can slow the disease
process not just treat the symptoms.
Dr. Goodman is a neuropsychologist
at Empire Neurology who has many years of experience and expertise in the detailed evaluation of memory disorders. He
and Dr. Edwards have had many peer review articles published along with dozens of international and national presentations
at major scientific meetings over 20 years. The current clinical research trials are given below and are registered
at clinicaltrials.gov
Currently Enrolling:
1. AAB-001-SC-ALZ-2003
Janssen Alzheimer Immunotherapy
A phase II, randomized, double-blind, placebo-controlled,
parallel group, multicenter, biomarker, safety and pharmacokinetic study of bapinezumab (AAB-001) administered subcutaneously
at monthly intervals in subjects with mild to moderate Alzheimer's disease.
Click here for more Information:
2. ABE4869g
Genentech Inc
A randomized, double-blind, placebo-controlled, parallel
group, multicenter, phase II study to evaluate the efficacy and safety of MABT5102A in patients with mild to moderate Alzheimer's
disease.
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