Currently Enrolling Research Studies

For more information, please click the appropriate Request More Information link in the studies outlined below OR simply call us at (919) 719-8826.


Alzheimer's Disease
There are currently no Alzheimer's Disease studies enrolling at this time. Please check back soon!

 

 

Multiple Sclerosis

ENLIGHTEN RPC-1063-MS-001

Title: A Multicenter, Longitudinal, Open-label, Single-arm study describing cognitive processing speed changes in Relapsing Multiple Sclerosis subjects treated with Ozanimod.

Purpose: To describe clinically meaningful changes in performance on the SDMT over a 3-year period in subjects with early MS receiving ozanimod HCl 1 mg.

Chance of Placebo: No chance of placebo (Open-Label)

Visit Schedule: Visits will occur once every 3 months over a three year period


Key Inclusion Criteria

  • Age 18 to 65 years
  • ≤ 5 years since time of Relapsing Multiple Sclerosis diagnosis

Key Exclusion Criteria

  • Has a presence of other neurologic disorders that might affect cognition
  • Has a history of developmental disorder (eg, attention-deficit/hyperactivity disorder [ADHD], learning disability)
  • Subject has received previous treatment with cladribine, Rituxan (rituximab), Ocrevus (ocrelizumab), or Lemtrada (alemtuzumab)
  • Subject has received previous treatment with Tysabri (natalizumab) or Gilenya(fingolimod)

GEMINI I EFC16033

Title: A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (GEMINI 1)

Purpose: To assess the efficacy of daily SAR442168 compared to teriflunomide (Aubagio) measured by annualized relapse rate in participants with relapsing forms of MS

Chance of Placebo: There is No Chance of Placebo. There is a 50% chance of receiving SAR442168 (study drug) and 50% chance of receiving Aubagio.

Visit Schedule: There is a variable treatment duration of 18-36 months with 20 total visits.


Key Inclusion Criteria

  • Participant must be between 18-55 years of age inclusive
  • Diagnosed with a Relapsing form of Multiple Sclerosis
  • Female participant not pregnant or breastfeeding

Key Exclusion Criteria

  • History of cancer within the past 5 years (except for effectively treated carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell carcinoma of the skin)
  • History of alcohol or drug abuse within 1 year prior

PERSEUS EFC16035

 

Title: A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)

Purpose: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in PPMS

Chance of Placebo: 67% chance of receiving SAR442168, 33% chance of receiving placebo

Visit Schedule: Study duration of up to 48 months with 26 onsite visits


Key Inclusion Criteria

  • Participant must be between 18-55 years of age inclusive
  • Diagnosed with Primary Progressive Multiple Sclerosis
  • Female participant not pregnant or breastfeeding

Key Exclusion Criteria

  • History of cancer within the past 5 years (except for effectively treated carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell carcinoma of the skin)
  • History of alcohol or drug abuse within 1 year prior

HERCULES EFC16645

 

Title: A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES)

Purpose: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in non-relapsing secondary progressive multiple sclerosis

Chance of Placebo: 67% chance of receiving SAR442168, 33% chance of receiving placebo

Visit Schedule: Study duration of up to 48 months with 26 onsite visits


Key Inclusion Criteria

  • Participant must be between 18-60 years of age inclusive
  • Previous diagnosis of Relapsing Remitting Multiple Sclerosis and current diagnosis of non-relapsing Secondary Progressive Multiple Sclerosis.
  • Female participant not pregnant or breastfeeding

Key Exclusion Criteria

  • History of cancer within the past 5 years (except for effectively treated carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell carcinoma of the skin)
  • History of alcohol or drug abuse within 1 year prior

FENTREPID GN41791

Title: A Phase III Multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with primary progressive multiple sclerosis

Purpose: To evaluate the safety efficacy of fenebrutinib compared with (Ocrevus) ocrelizumab in patients with Primary Progressive Multiple Sclerosis (PPMS)

Chance of Placebo: No chance of placebo. Patient will be receiving active fenebrutinib and placebo Ocrevus (ocrelizumab) or active Ocrevus (ocrelizumab) and placebo fenebrutinub. Patients will have to take daily oral tablets (fenebrutinib or placebo) as well as IV infusions (ocrelizumab or placebo).

Visit Schedule: The study is approximately 4 and a half to 7 years long. There is an optional Open- label Extension.


Key Inclusion Criteria

  • Age18-65 years
  • A diagnosis of Primary Progressive Multiple Sclerosis (PPMS)

Key Exclusion Criteria

  • Any infections
  • History of cancer within 10 years
  • Previous use of Ocrevus (ocrelizumab)within 6 months, and treatment discontinuation was not motivated by safety reasons or lack of being effective.
  • Previous use of Tysabri (natalizumab) for more than 1 year and within 6 months of randomization

EXCHANGE CBAF312AUS02

Title: Exploring the safety and tolerability of conversion from oral or injectable disease-modifying therapies to dose-titrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6-month open-label, multi-center Phase IIIb study

Purpose: To assess early phase safety and tolerability of converting patients from approved oral, injectable, and infusion RMS DMTs to siponimod (Mayzent).

Chance of Placebo: No Chance of Placebo. This study is open-label; therefore all patients will receive siponimod.

Visit Schedule: This study lasts 6-months (5 office visits)


Key Inclusion Criteria

  • Age 18 to 65 years of age
  • Patients with advancing Relapsing Multiple Sclerosis (with or without progressive features)
  • Having been continuously treated with beta-interferons, glatiramer acetate, fingolimod, dimethyl fumarate, or teriflunomide for at least 3 months at the time of consent OR having had last natalizumab dose at least 4 weeks before screening OR last ocrelizumab dose 14 weeks prior to screening.

Key Exclusion Criteria

  • Patients with an active chronic disease of the immune system other than MS or with a known immunodeficiency syndrome
  • There are several exclusionary medications/medications with special guidelines that will be assessed by the Clinical Research Coordinator

 

 

Parkinson's Disease

PRISM NLY01-PD-1


Title
: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 36 weeks treatment with NLY01 in Early-Stage Parkinson’s Disease (PD).

Purpose: To assess the safety, tolerability and efficacy of NLY01 in the early, untreated PD population along with the potential beneficial effects of NLY01 on clinical features of PD

Chance of Placebo: NLY01 is being studied at two different dose levels, given subcutaneously. You will have a 2 in 3 chance of receiving the investigational drug and a 1 in 3 chance of receiving placebo. This means you have a higher chance of receiving the investigational drug.

Visit Schedule: The study will last approximately 12 months. Including the screening visit, there will be approximately 10 on site visits and 5 telephone visits over a 12 month period. On-site visits typically last 1.5-5 hours on average.


Key Inclusion Criteria

  • Age 30-80
  • Diagnosis of Parkinson’s Disease

Key Exclusion Criteria

  • Diagnosis of PD for more than 5 years before screening
  • Current treatment with levodopa, pramipexole(Mirapex®, Mirapex ER®), ropinirole(Requip®), rotigotine(Neupro®), rasagiline(Azilect®), amantadine(Gocovri®), and/or entacapone(Comtan®)
  • History of thyroid malignancy, pancreatitis, or Type 1 or Type 2 diabetes

 

 

Rheumatology There are currently no Rheumatology studies enrolling at this time. Please check back soon!

 

 

Sleep Medicine There are currently no Sleep Medicine studies enrolling at this time. Please check back soon!

 

 

Other Neurological Indications There are currently no other studies enrolling at this time. Please check back soon!