Current Research

If you would like to inquire about or participate in research projects at DENT, please contact us at 716-250-2038 for additional information. Below is a listing of our current studies.

EPILEPSY RESEARCH:

Living with Epilepsy

Do you have partial onset seizures due to epilepsy? It is estimated that more than two million people in the U.S. alone have active epilepsy.  And, of these patients, approximately25% to 30% do not respond well to conventional antiepileptic treatments.

If you or someone you care about is living with epilepsy and continuing to experience partial onset seizures, even with treatment, you may want to consider the SEA (Sunovion Eslicarbazepine Acetate) study, a new medical research study evaluating an investigational antiepileptic drug (AED).

To qualify for this study, you must:

• Be 16-70 years of age,
• Have had at least four partial onset seizures in the last eight weeks,
• Not have gone 28 days without a seizure over the last eight weeks, and
• Have been taking one to two antiepileptic drugs for the last four weeks

Qualified participants will receive study-related medical evaluations and the study medication at no cost.  Reimbursement for time and travel may also be provided. 

FOR MORE INFORMATION CONTACT:
Michelle Rainka. Pharm.D. :  716-250-2038
Kristin Surdam, BA : 716-819-4117

Visit: www.TeamEpilepsy.net

ALZHEIMER’S DISEASE NEUROIMAGING INITIATIVE

 Are you concerned about Alzheimer’s?

Would you be interested in helping researchers learn how to stop the progress of this heartbreaking disease?

Dent Neurologic Institute is participating in a landmark research study sponsored by the National Institutes of Health (NIH) with private sector support provided through the Foundation for the National Institutes of Health (FNIH). The Canadian Institute of Health Research (CIHR) will help support the Canadian research sites.

Our goal is to determine whether imaging of the brain (through MRI, PET and amyloid imaging scans) can help predict and monitor the onset and progression of Alzheimer’s

Disease. In addition to neuroimaging, the study will collect and test blood and cerebrospinal fluid to determine if biomarkers can predict and monitor the disease. Testing cerebrospinal fluid is one of the important ways to obtain vital brain information.

RESEARCHERS ARE LOOKING FOR PEOPLE WHO:

• Are between 55 and 90 years old
• Are in good general health
• Either have a diagnosis of early Alzheimer’s disease, MCI, or are cognitively normal
• Are fluent in English or Spanish
• Are willing and able to undergo in-clinic assessments, memory testing and other test procedures
• Have a study partner – a friend or relative who can accompany the volunteer to all clinic visits

Your health will be closely monitored by a team of doctors and nurses. Any new information about your physical health will be shared with you and your physician (you are encouraged to continue seeing your regular doctor).

No study drug is used in this research study. You will receive compensation for your time and for costs incurred for travel, parking and meals.

To find out more about this study, please contact:

Dr. Michelle Rainka  (716) 250-2038

Kristin Surdam  (716) 819-4117

 You can also visit the ADCS website at: http://adcs.org/Default.aspx

 Additional trials in Alzheimer’s Disease coming soon!

Orchestra – Opera

 The sound of a new research opportunity in multiple sclerosis

 The Opera Studies

•  Have you been diagnosed with a relapsing form of multiple sclerosis (MS)?
• Have your symptoms returned at least twice within the past 2 years or once within the past year?
• Are you 18-55 years of age?

If you answered yes to all three questions, you could be eligible to participate in a clinical research study looking at whether an investigational drug can reduce the number of relapses compared with a treatment already approved for MS. All participants will receive either the investigational drug or an approved medication, called Rebif.

 For more information, contact:

            Michelle Rainka, Pharm.D. at 716-250-2038 

            Kristin Surdam, B.A. at 716-819-4117  

Adolescent Bipolar Disorder

Does your teen suffer from bipolar disorder?

Your child may suffer from bipolar illness or another mental disorder. Symptoms include feelings of heightened energy, creativity and euphoria at one stage and irritability, guilt, unpredictable mood swings and feelings of restlessness at another stage.

Your teen may be eligible to participate in a research study. Participants must be 12 to 17 years of age and generally healthy. Those who qualify will receive study-related mental health assessments, physical exams, lab services and an investigational medication or placebo (inactive substance).

For more information, contact:

Michelle Rainka, Pharm.D. at 716-250-2038 

Kristin Surdam, B.A. at 716-819-4117  

Additional mental health research is ongoing. Call for details!

HEADACHE/MIGRAINE RESEARCH

OptiNose, Inc/PharmaNet - OPN-SUM-MIG-3301: Headache Device Trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally with the Bi-Directional Device in Adults with Acute Migraine With or Without Aura

Inclusion Criteria:

• Men and women between the ages of 18 and 68, inclusive
• Have a diagnoses of episodic migraine, with or without aura for at least 1 year prior to screening
• Experience between 1 and 8 migraine attacks per month for the past 12 months
• Women must be practicing an effective method of birth control before entry and throughout the study, or be surgically sterile, or be postmenopausal for at least 1 year prior to screening
• Demonstrate the ability to use the bi-directional delivery device correctly
• Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol
• Must be on stable migraine prophylaxis dose for at least 30 days prior to screening
• Chronic opioid therapy patient will be excluded from participating (>3 consecutive days in the 30 days prior to screening)
• Current treatment with antipsychotic medications (taken for any indication) or use within 4 weeks before randomization patient will be excluded from participating

• Willing to accept randomization

FOR MORE INFORMATION CONTACT:
Olga I. Ananina, Clinical Research Coordinator: 716-558-5670

PREMIUM Migraine Clinical Trial

Sponsored by AGA Medical Corporation

A research study to evaluate incidence of headache reduction in subjects with migraine and PFO using the Amplatzer PFO Occluder compared to medical management.

Qualified participants will be:

• 18 to 65 years of age, inclusive
• Diagnosed as having migraine headaches with and/or without aura
• Must demonstrate an average of at least 6 migraine headache days, but no more than 14 total headache days for each 30-day period during the 60-day baseline phase
• Must demonstrate the presence of a PFO using Transcranial Doppler with significant shunt defined as Grade 4 & Grade 5 on Valsalva
• Must have failed a trial of at least three preventive medications during her/his lifetime
• Willing to participate in the required follow-up visits
• Willing to accept randomization
• Willing to comply with maintaining a headache diary

FOR MORE INFORMATION CONTACT:
Olga I. Ananina, Clinical Research Coordinator: 716-558-5670

TREXIMET Aura Clinical Trial

Sponsored by Laszlo L. Mechtler, M.D.

A parallel two arm, double blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.

Qualified participants will be:

• 18 to 50 years of age, inclusive
• Carry a diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion
• Have an onset of a visual aura that occurs 15-30 minutes before a migraine headache
• Able to understand and complete a migraine diary
• In generally good health as confirmed by medical and medication history
• Female subjects must be either a) postmenopausal for one year, b) surgically sterile, c)on acceptable birth control for at least 1 month prior to screening and throughout the study, or d) practicing abstinence and agree to continue same throughout study.

FOR MORE INFORMATION CONTACT:
Olga I. Ananina, Clinical Research Coordinator: 716-558-5670

BRAIN TUMOR/ONCOLOGY RESEARCH

Celldex Therapeutics, Inc. - CDX110-04: Glioblastoma Vaccine Trial

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The "ACT IV" Study)

Inclusion Criteria:

• Men and women who are 18 years of age or older
• Histologically confirmed, newly diagnosed, de novo glioblastoma, including the following recognized variants of glioblastoma: small cell glioblastoma, giant cell glioblastoma, gliosarcoma and glioblastoma with oligodendroglial component (central pathologic review will be performed and histologic confirmation will be required prior to study entry)
• Attempted surgical resection followed by conventional chemoradiation
• Tumor tissue specimens from surgical resection must be available for central pathology review
• No evidence of progressive disease from the post-operative period to the post-chemoradiation period, based on changes in the neurologic exam, steroid use, or evident radiographic progression
• Personally signed and dated informed consent document indication that the patient has been informed of and agreed with all pertinent aspects of the study
• Willing to accept randomization

FOR MORE INFORMATION CONTACT:
Olga I. Ananina, Clinical Research Coordinator: 716-558-5670