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Research Studies

The Neurology Center of New England conducts clinical trials with the goal of advancing the development of new treatments and diagnostic tools for our current and future patients.

The success of finding new treatments and therapies relies on there being enough people willing to participate in clinical trials.

Please select a study below for information. If you would like more information to be involved in a study, please follow the link provided in the specific study section, noted “Click here for more information.”

If you have questions about these research studies or would like to participate, please contact Sarah Cardoso at  research@myneurodr.com.


Acthar Gel

Reveal:  This observational study aims to characterize the patient population and describe multiple sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in standard practice in the United States.

Purpose:  

A prospective observational registry of H.P Acthar Gel for the treatment of Multiple Sclerosis relapse.

For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT02633033

Study Population:

Multiple Sclerosis Relapse-Remitting Patients
Sponsor: Mallinckrodt

Click here for more information

Comparative Study of two MS Medications

Reveal: Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis 

Purpose:  A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Comparing the Efficacy and Safety of Ofatumumab administered subcutaneously versus Teriflunomide administered orally in patients with relapsing forms of Multiple Sclerosis.

For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT02792218

Study Population: 

Relapsing Forms of Multiple Sclerosis

Sponsor: Novartis

→ Click here for more information

Long Term Safety of Lemtrada

Purpose:

 A Prospective, Multicenter, Observational Post-Authorization Safety Study to Evaluate the Long-Term Safety Profile of Lemtrada Treatment in Patients with Relapsing Forms of Multiple Sclerosis

Please contact Sarah Cardoso by emailing: research@myneurodr.com for more information.

Population:

Patients with Relapsing forms of Multiple Sclerosis 

Sponsor: Genzyme

Ocrelizumab for Early Stage RRMS

Purpose:

MA30143 ENSEMBLE Open-label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage RRMS. 

For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT03085810

Study Population:

Patients with early stage Relapsing-Remitting Multiple Sclerosis

Sponsor: Genentech

→ Click here for more information

PASSAGE study

Reveal: PASSAGE Long-term, Prospective, Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy.

Purpose: The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with Fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of Fingolimod under conditions of routine medical practice.  

For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT01442194

 

Study Population:

Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy.

Sponsor: Novartis

→ Click here for more information

Tecfidera Study

Reveal: Dimethyl Fumarate (DMF) Observational Study (ESTEEM)

Purpose: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM).

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF).

Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and Multiple Sclerosis (MS) relapse information; and to assess the effect of Dimethyl Fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT02047097

 

Study Population:

Multiple Sclerosis Patients on Tecfidera (Dimethyl Fumarate)

Sponsor: Biogen

→ Click here for more information

RMS Lemtrada

Purpose: 

This study is to describe neurocognitive function in patients with relapsing multiple sclerosis (RMS) treated with LEMTRADA® in routine clinical practice as measured by the Multiple Sclerosis Cognitive (MS-COG) composite score. Additional neurocognitive tests will also be administered and reviewed as well as MRI data when available. The study includes a screening period of up to 30 days followed by a baseline visit, month 12 and month 24/EQS visit for a total of four visits.

For eligibility and information about this trial please contact our research department.

 

Study Population:

Patients with Relapsing Multiple Sclerosis taking Lemtrada

Sponsor: Sanofi/Genzyme

Management of Parkinson's Disease Psychosis

Purpose:

To examine the current disease progression of Parkinson’s Disease Psychosis, the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers.  For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT03152292.

 

Study Population:

Parkinson’s Disease

Sponsor: Acadia Pharmaceuticals Inc

→ Click here for more information

IDEAS Study

Reveal:

Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage With Evidence Development Longitudinal Cohort Study.

Purpose:

The IDEAS Study will establish an open-label, longitudinal cohort study to assess the impact of amyloid PET on patient outcomes. The study will be performed in accordance with the Center for Medicare & Medicaid Services (CMS) policy of Coverage with Evidence Development (CED) in Medicare beneficiaries who meet the Appropriate Use Criteria (AUC) for amyloid PET (Johnson et al. 2013).

Our hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the underlying cause of cognitive impairment, that this will translate into earlier counseling and interventions in these domains, and that these interventions will lead to improved outcomes.  For eligibility and information about this trial please contact our research department or on the web at clinicaltrials.gov and enter the clinical trial identifier NCT02420756

Study Population:

Dementia and Alzheimers Study

Sponsor: American College of Radiology Imaging Network in Collaboration with the Alzheimer’s Association

→ Click here for more information