A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:1/18/2019
Start Date:September 2015
End Date:February 2018

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A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple
crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without
cataplexy (Type 2).


Inclusion Criteria:

- Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic
treatment for the condition

- Usual nightly total sleep at least 6 hours as single major rest period without naps

- Epworth Sleepiness Scale of 10 or greater

- Males or females age 18 to 65 years

Exclusion Criteria:

- Any disorder causing hypersomnia other than IH or Narcolepsy Type 2

- Usual bedtime later than midnight

- Seizure disorder or history of syncope, unexplained loss of consciousness or seizure
in the past 3 years

- Beck Depression Inventory score greater than 19

- Beck Anxiety Inventory score greater than 15

- Significant history of or current suicidal ideation or behavior

- BMI less than 18 kg/m2 or greater than 39 kg/m2

- Positive toxicology screen or breathalyzer test

- Clinically significant abnormal findings on safety assessments

- Any significant medical or psychiatric disease or any condition that would put the
patient at risk by participating in the study
We found this trial at
23
sites
Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem, MD
Phone: 301-654-5665
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
Principal Investigator: Russell Rosenberg, MD
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790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
Principal Investigator: Robert Doekel, MD
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12 Executive Park Drive Northeast
Atlanta, Georgia 30329
Principal Investigator: Romy Hoque, MD
Phone: 404-712-7533
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Austin, Texas 78731
Principal Investigator: John Hudson, MD
Phone: 512-380-9925
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4895 Riverbend Road
Boulder, Colorado 80301
Principal Investigator: John Harsh, MD
Phone: 720-279-9098
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Brandon, Florida 33511
Principal Investigator: Daniel Lorch, MD
Phone: 813-657-1584
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Cincinnati, Ohio 45255
Principal Investigator: James Maynard, MD
Phone: 513-281-3868
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Cincinnati, OH
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Columbia, South Carolina 29201
Principal Investigator: Richard Bogan, MD
Phone: 803-251-3093
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Houston, Texas 77063
Principal Investigator: Todd Swick, MD
Phone: 713-465-7066
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Houston, TX
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Louisville, Kentucky 40217
Principal Investigator: David Winslow, MD
Phone: 502-479-1217
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Macon, Georgia 31201
Principal Investigator: Charles Wells, MD
Phone: 478-745-5779
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1650 Beam Avenue
Maplewood, Minnesota 55109
Phone: 651-326-4448
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Andrew Westwood, MD
Phone: 212-305-1742
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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70 Wells Avenue
Newton, Massachusetts 02459
Phone: 617-581-6434
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Oklahoma City, Oklahoma 73112
Principal Investigator: William Orr, PhD
Phone: 405-447-8839
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Oklahoma City, OK
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Palo Alto, California 94304
Principal Investigator: Emmanuel Mignot, MD
Phone: 650-736-6607
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Principal Investigator: Singar Jagadeesan, MD
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Saint Louis, Missouri 63143
Principal Investigator: Joseph Ojile, MD
Phone: 314-645-6005
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Saint Petersburg, Florida 33707
Principal Investigator: Neil Feldman, MD
Phone: 727-360-0853
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San Diego, California 92103
Principal Investigator: Stephen Thein, PhD
Phone: 619-294-4302
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Sarah Stolz, MD
Phone: 206-320-6006
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Upland, California 91786
Principal Investigator: Yogesh Paliwal, MD
Phone: 909-981-5321
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