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

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

Padova BN42358


Title
: A phase IIB, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of intravenous prasinezumab in participants with early Parkinson’s disease.

Purpose: To investigate the treatment effect of prasinezumab relative to placebo on time to clinical disease progression in subjects with early Parkinson’s disease.

Chance of Placebo: You will have a 50% (1 in 2) chance of receiving study drug and a 50% (1 in 2) chance of receiving placebo.

Visit Schedule: On average, the visits occur once monthly and last between 2.5 to 5 hours. Study duration is at least 76 weeks for all participants and will continue until a minimum of 248 participants experience a > 5-point worsening in MDS-UPDRS Part III score.


Key Inclusion Criteria

  • Age 50-85 years
  • A diagnosis of Parkinson’s Disease for at least 6 months to maximum 3 years at screening
  • Monotherapy treatment with MAO-B inhibitors (up to 1 mg rasagiline per day, or up to 10 mg selegiline per day) or up to 450 mg L-Dopa per day given for at least 6 months, with stable doses for 3 months prior to baseline

Key Exclusion Criteria

  • History of Parkinson’s Disease-related freezing episodes or falls
  • History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, non-metastatic prostate cancer, or Stage I uterine cancer
  • The use of fluoxetine, fluvoxamine, antipsychotics, and marijuana is not permitted. 

 

 

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!

Sparkle Part B TAK-994-1501

Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE RISING ORAL DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETCS, AND PHARMACODYNAMICS OF TAK-994 IN PATIENTS WITH NARCOLEPSY WITH OR WITHOUT CATAPLEXY (NARCOLEPSY TYPE 1 OR NARCOLEPSY TYPE 2)

Purpose: The main purpose of this study is to look at how safe TAK-994 is and how well the body handles taking it. The study will also look at how the body processes the study drug and how the study drug affects the body and symptoms of narcolepsy, such as wakefulness, alertness, and if cataplexy occurs less frequently.

Chance of Placebo: 25%

Visit Schedule: Screening Period up to 45 days, Study Treatment Period up to 56 days. Follow up period up to 9 days. There will be 11 visits to the study center including up to 10 overnight stays.


Key Inclusion Criteria

  • Aged 18 to 65 years
  • Diagnosis of Narcolepsy with cataplexy by PSG/MSLT performed within the past 10 years
  • Willing to discontinue all medications used for the treatment of narcolepsy
  • BMI greater than or equal to 17 and less than or equal to 40
  • Greater than or equal to 4 cataplexy episodes a week during the screening period

Key Exclusion Criteria

  • Subjects on fluoxetine (any dose) or on greater than or equal to 300 mg/day of venlafaxine
  • A medical disorder other than narcolepsy associated with excessive daytime sleepiness.
  • Unwilling to abstain from driving during study participation
  • Usual bedtime later than 12:00 AM, midnight or an occupation requiring nighttime shift work

Sparkle Part D TAK-994-1501

Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE RISING ORAL DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETCS, AND PHARMACODYNAMICS OF TAK-994 IN PATIENTS WITH NARCOLEPSY WITH OR WITHOUT CATAPLEXY (NARCOLEPSY TYPE 1 OR NARCOLEPSY TYPE 2)

Purpose: The main purpose of this study is to look at how safe TAK-994 is and how well the body handles taking it. The study will also look at how the body processes the study drug and how the study drug affects the body and symptoms of narcolepsy, such as wakefulness, and alertness.

Chance of Placebo: 33%

Visit Schedule: The study may last for up to 82 days. Screening period up to 45 days. Study Treatment period up to 28 days. Follow up period up to 9 days. Up to 11 visits to the study center including 4 to 7 overnight stays.


Key Inclusion Criteria

  • Aged 18 to 65 years
  • Diagnosis of Narcolepsy by PSG/MSLT performed within the past 10 years
  • Willing to discontinue all medications used for the treatment of narcolepsy
  • BMI greater than or equal to 17 and less than or equal to 40

Key Exclusion Criteria

  • Subjects on fluoxetine (any dose) or on greater than or equal to 300 mg/day of venlafaxine
  • A medical disorder other than narcolepsy associated with excessive daytime sleepiness.
  • Unwilling to abstain from driving during study participation
  • Usual bedtime later than 12:00 AM, midnight or an occupation requiring nighttime shift work

 

 

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