The Saul R. Korey Department of Neurology

Research Studies

 

FLAMEL/AVADEL/REST-ON/Protocol CLFT281-1501

This clinical research study is being done to understand how safe and effective an investigational medication (sodium oxybate) is in reducing excessive daytime sleepiness and cataplexy in subjects with narcolepsy. 

 
Who can participate?
People 16 years or older with a diagnosis of narcolepsy who experience:

  • Excessive daytime sleepiness AND cataplexy

 Pre-screening brochure 

 Study status: recruiting patients
Principal investigator: Michael Thorpy, MD

 
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-4841
Email: mfiguera@montefiore.org

 
ClinicalTrials.gov: NCT02720744 

Jazz Pharmaceuticals/PASSAGE/Protocol JZP166-201

The PASSAGE study is a clinical research study looking at the safety and efficacy of an investigational medication for sleepiness in patients with Parkinson’s disease. 

 
Who can participate?
People between 35 and 80 years of age with a diagnosis of Parkinson’s disease who experience:

  • Excessive daytime sleepiness, despite spending 6 or more hours in bed
  • Have not been diagnosed with obstructive sleep apnea or narcolepsy

 Screening brochure 

Study status:  not recruiting patients
Principal investigator: Renee Monderer, MD
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-4841
Email: mfiguera@montefiore.org

 
ClinicalTrials.gov: NCT03037203 

Jazz Pharmaceuticals/EXPRESS/Pediatric effects of Xyrem/Protocol JZP13-005

In the EXPRESS study doctors and researchers want to learn more about the effects of a study medication (Xyrem) when it is used to treat narcolepsy with cataplexy in children. 

 
Who can participate?
Children between 7 and 18 years of age with a diagnosis of narcolepsy who have completed part 1 of the study.

 
Study status: not recruiting patients
Principal investigator: Imran Ahmed, MD

 
ClinicalTrials.gov: NCT02221869 

Jazz Pharmaceuticals/Low sodium Xyrem/Protocol JZP15-006

This clinical study will evaluate how safe and effective is an investigational medication (JZP-258) as compared to placebo treating cataplexy attacks and excessive daytime sleepiness in patients with narcolepsy with cataplexy.

 
Who can participate?
People between 18 and 70 years of age with a diagnosis of narcolepsy with cataplexy.

 
 Study brochure 

 Study status: recruiting patients
Principal investigator: Michael Thorpy, MD
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-4841
Email: mfiguera@montefiore.org

ClinicalTrials.gov: NCT03030599 

Harmony Biosciences/Pitolisant/HBS-101-CL-001

This is an open label extended access program intended to provide treatment with Pitolisant to adult patients in the U.S.A. with excessive daytime sleepiness associated with narcolepsy with or without cataplexy.

Who can participate?
People 18 years of age and over with a narcolepsy with or without cataplexy diagnosis.

 
Study status: recruiting patients
Principal investigator: Michael Thorpy, MD
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-4841
Email: mfiguera@montefiore.org

ClinicalTrials.gov: NCT03433131 

Previous Studies

Restless Leg Syndrome post Bariatric Surgery 

Dr. David Appel and Dr. Renee Monderer are conducting a study to determine the incidence of Restless Leg Syndrome in patients after bariatric surgery.

Sleep Related Epilepsy 

Dr. Imran Ahmed is researching the association between Electrographic Status Epilepticus in Sleep (ESES), its treatment and sleep.

Pediatric Sleep Research 

Dr. Ranaan Arens and Dr. Hiren Muzumdar are currently working on multiple research projects in the Pediatric Pulmonary Department. One of these studies is investigating heart rate variability in children with obstructive sleep apnea. Another study is looking at the effect of weight loss and weight gain on airway anatomy in children.

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