Overview of Clinical Trials at Associated Neurologists of Southern Connecticut, PC

Associated Neurologists of Southern Connecticut, PC, a private practice with many years of in-depth experience and expertise in neurological care, have been providing excellence in quality care to patients in Fairfield and New Haven Counties for over twenty-five years. We have affiliations with St. Vincent's Medical Center, Milford Hospital and Bridgeport Hospital.

Currently there are nine neurologists in our group with various subspecialties including stroke, neuromuscular disease, dementia, alzheimer's disease, epilepsy, headache, neurorehabilitation and critical care. The staff includes Neuropsychologists, Physician Assistants, Director of Clinical Research, Clinical Research Manager, Administrative Research Assistant, three Clinical Research Coordinators, a Registered Nurse, and five EEG Technologists.

It is our goal to progress both clinically and professionally through clinical trials and continued medical education so that we can provide the most advanced and sophisticated treatment options available. Our utmost concern is patient safety and welfare; therefore, we abide by Good Clinical Practice standards to ensure the highest quality and integrity in data collection and analysis.

Our research department conducts multiple clinical trials. To date, 27 clinical trials, both in-patient and out-patient, have been completed in the areas of Stroke, Transient Ischemic Attacks, Parkinson's Disease, Migraine, Chronic Headache, Chronic Pain, Multiple Sclerosis and Epilepsy.

Currently Enrolling Clinical Trials at Associated Neurologists of Southern Connecticut, P.C. (ANSC)

Alzheimer's

Blepharospasm (BEB) Study

Migraines

Multiple Sclerosis

Over Active Bladder

Parkinson's Disease

Partial Seizures

Spasticity

The table above contains diagnosis specific studies being conducted by Associated Neurologists of Southern Connecticut. To acquire more information, click on diagnosis to view current trials in that area or call 203.333.1151.

If you would like further information about Clinical Trials at Associated Neurologists of Southern Connecticut, please contact Angelo Termine, Clinical Research Manager at atermine@anscneuro.com , Donna Pomes at dpomes@anscneuro.com or any of our Clinical Research Coordinators, Sharon Kingson at skingson@anscneuro.com, Mary Ann Traut at mtraut@anscneuro.com , Dale Ferguson at dferguson@anscneuro.com or J. Velotta at jvelotta@anscneuro.com or you may call 203.333.1151 and we will be happy to answer any of your questions.

Alzheimer’s Study

Study Purpose: To investigate the effects of daily dosing for 24 weeks with study medication vs. placebo on cognitive function in subjects with mild to moderate Alzheimer’s disease.

Basic Eligibility Criteria:

• 50-90 years of age
• Clinical diagnosis of probable Alzheimer’s disease
• Subject has a regular caregiver who is willing to attend all visits

Blepharospasm (BEB) Study

Study Purpose: To investigate the efficacy and safety of NT 201 compared with placebo in patients with BEB.

Basic eligibility criteria:

• 19 to 80 years old
• Clinical diagnosis of bilateral BEB
• A need for injection of Botulinum toxin

Migraine Study

Study Purpose: To determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning.

Basic eligibility criteria:

• 18 to 64 years of age
• Migraine with or without aura and primary insomnia
• 4-12 migraines per month with a maximum of 20 days with headache per month

Migraine Study

Study Purpose: To assess the efficacy and safety of an inhaler medication in patients with migraine headache with or without aura, in a clinical setting.

Basic eligibility criteria:

• 18 to 65 years of age
• Migraine headache with or without aura for 6 months
• At least 3 migraine attacks in the last 3 months (but not more than 8 migraine attacks in the last 30 days)

Migraine Study

Study Purpose: To evaluate the safety and tolerability of a combination tablet in the long-term treatment of migraine in adolescents 12 to 17 years of age.

Basic eligibility criteria:

• 12 to 17 years old
• Migraines with or without aura
• Has 2 but not more than 8, migraine attacks per month
• At least a 6-month history of moderate to severe migraine attacks
• Able to understand and complete the electronic device to report treatment information

Multiple Sclerosis Study

Study Purpose: To evaluate the add-on treatment effect of oral steroids on brain volume changes in relapsing remitting multiple sclerosis patients.

Basic eligibility criteria:

• 18-55 years of age
• Patients must be ambulatory
• Must have had at least 1 documented relapse within the last year

Multiple Sclerosis Study

Study Purpose: To evaluate the efficacy of study medication in reducing the frequency of relapses compared to placebo in patients with RRMS treated for up to 24 months.

Basic eligibility criteria:

• 18 through 55 years of age
• Relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years

Multiple Sclerosis a Cognition Study

Study Purpose: To assess the efficacy of the study medication in improving measures of cognition and fatigue using primary and secondary assessments.

To assess the safety and tolerability of a study medication based on evaluation of adverse events, physical examination, vital signs, laboratory results and ECG test results.

Basic eligibility criteria:

• 18 years old and below the age of 65
• Presence of cognitive deficit

Epilepsy Study

Study Purpose: To find out the usefulness and safety of study medication for the treatment of partial seizures when it is used to replace another seizure medication.

Basic Eligibility Criteria:

• 13 years of age
• Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeks.
• Be currently receiving AED monotherapy treatment.

Parkinson's Disease

Study Purpose: To evaluate the safety and efficacy of two doses of ACP-103 (10mg and 40mg) compared to placebo in the treatment of psychosis in Parkinson’s disease. To demonstrate the antipsychotic efficacy of ACP-103 in subjects with PDP as measured by a decrease in the severity and/or frequency of hallucinations and/or delusions.

Basic eligibility criteria:

• 40 years of age or older
• Clinical diagnosis of idiopathic Parkinson’s disease
• Presence of visual and/or auditory hallucinations, and/or delusions
• Symptoms severe enough to warrant treatment with an antipsychotic agent

Overactive Bladder Study

Study Purpose: To study the safety and efficacy of study medication compared to placebo for the treatment of urinary incontinence.

Basic Eligibility Criteria:

• 18-80 years old
• Weigh at least 110 lbs.

Partial-onset Seizure Study

Study Purpose: To demonstrate the efficacy and safety of study medication for partial-onset seizures compared to other anti-epilepsy drugs.

Basic Eligibility Criteria:

• 16-70 years of age
• Willing and able to comply with all trial requirements.

Limb Spasticity in Patients with Mild Respiratory Difficulty

Study Purpose: To test the effectiveness and safety of an investigational drug for the treatment of spasticity of either arm due to stroke, in patients with mildly impaired breathing.

Basic Eligibility Criteria:

• Age 21 or older
• Spasticity of one arm
• Mild breathing problems
• Must be stable and stay on current allowed medications during the course of the study

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