Suven Life Sciences/Protocol CTP2S13031H3/Narcolepsy
This is a study to evaluate how effective an investigational medication (SUVN-G3031) is compared to placebo at improving excessive daytime sleepiness in patients with narcolepsy with or without cataplexy.
Who can participate?
People between 18 and 50 years of age diagnosed with narcolepsy with or without cataplexy. To be eligible patients must have no other conditions known to cause sleep disruption or excessive daytime sleepiness. No severe heart, liver, kidney, gastrointestinal, neurological or psychiatric conditions.
Study status: recruiting patients
Principal investigator: Michael Thorpy, MD
For more information go to the ClinicalTrials.gov site: NCT04072380 and HERE
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-2895
Email: mfiguera@montefiore.org
Takeda/Protocol TAK-994-1501/Narcolepsy
This is a study to evaluate how safe and effective an investigational medication (TAK-994) is compared to placebo at improving excessive daytime sleepiness in patients with narcolepsy with or without cataplexy.
Who can participate?
People between 18 and 65 years of age diagnosed with narcolepsy with or without cataplexy, with no other conditions known to cause sleep disruption or excessive daytime sleepiness. No severe heart, liver, kidney, gastrointestinal, neurological or psychiatric conditions.
Study status: recruiting patients
Principal investigator: Michael Thorpy, MD
For more information go to the ClinicalTrials.gov site: NCT04096560 and HERE
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-2895
Email: mfiguera@montefiore.org
TATCH/Protocol TCH-103/Sleep Apnea
This is a study to evaluate the performance of an investigational device to detect sleep breathing disorders such as sleep apnea.
Who can participate?
People at least 18 years of age that need to undergo a nighttime sleep study (nocturnal polysomnography –nPSG–) to diagnose sleep breathing disorders. To be eligible patients must have been prescribed a nPSG study at the Montefiore Sleep-Wake Disorders Center and have no severe health conditions or latex allergy that could prevent the patient from completing the study.
Study status: recruiting patients
Principal investigator: Imran Ahmed, MD
For more information go to the ClinicalTrials.gov site: NCT04419714
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-2895
Email: mfiguera@montefiore.org
Jazz Pharmaceuticals/CHORDS/Protocol JZP080-301/Idiopathic hypersomnia
Who can participate?
People between 18-75 years of age diagnosed with idiopathic hypersomnia and no other sleep disorders or severe medical conditions that could compromise the safety of the patient if they participate in the clinical trial.
Study status: recruitment closed
Principal investigator: Michael Thorpy, MD
For more information go to the ClinicalTrials.gov site: NCT03533114
If you are interested in this study, please contact us:
Phone: 718-920-2880 or 781-920-2895
Email: mfiguera@montefiore.org
Previous Studies
Balance Therapeutics/Arise 2/BTD-001 IH202
The main objective of the Arise 2 study was to test how effective an investigational medication called BTD-001 (pentetrazol) was at treating idiopathic hypersomnia.
FLAMEL/AVADEL/REST-ON/Protocol CLFT281-1501
The main goal of this clinical research study was to understand how safe and effective an investigational medication (once nightly form of sodium oxybate) was at reducing excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
AXSOME Therapeutics/CONCERT/AXS-12-201
The main objective of the CONCERT study was to test how effective and safe an investigational medication called AXS-12 was at treating cataplexy and excessive daytime sleepiness in people with narcolepsy.
Harmony Biosciences/Pitolisant/HBS-101-CL-001
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.
Jazz Pharmaceuticals/PASSAGE/Protocol JZP166-201
The PASSAGE study was a clinical research study looking at the safety and efficacy of an investigational medication for sleepiness in patients with Parkinson’s disease.
Jazz Pharmaceuticals/EXPRESS/Pediatric effects of Xyrem/Protocol JZP13-005
In the EXPRESS study doctors and researchers wanted to learn more about the effects of a study medication (Xyrem) when used to treat narcolepsy with cataplexy in children.
Jazz Pharmaceuticals/Low sodium Xyrem/Protocol JZP15-006
This clinical study evaluated how safe and effective was an investigational medication (JZP-258) as compared to placebo at treating cataplexy attacks and excessive daytime sleepiness in patients with narcolepsy with cataplexy.
Restless Leg Syndrome post Bariatric Surgery
Dr. David Appel and Dr. Renee Monderer conducted a study to determine the incidence of Restless Leg Syndrome in patients after bariatric surgery.
Sleep Related Epilepsy
Dr. Imran Ahmed looked at the association between Electrographic Status Epilepticus in Sleep (ESES), its treatment and sleep.
Pediatric Sleep Research
Dr. Ranaan Arens and Dr. Hiren Muzumdar worked on multiple research projects in the Pediatric Pulmonary Department. One of these studies was investigating heart rate variability in children with obstructive sleep apnea. Another study was looking at the effect of weight loss and weight gain on airway anatomy in children.