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

Idiopathic Hypersomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512588
• Other study ID #: BTD-001 IH201
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: February 2018

Study information

• Verified date: January 2019
• Source: Balance Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataplexy
• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia
• Narcolepsy
• Narcolepsy Without Cataplexy

Intervention

Drug:
• BTD-001

• Placebo

Locations

Country	Name	City	State
United States	Emory University School of Medicine Emory Sleep Center	Atlanta	Georgia
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	Future Search Trials of Neurology	Austin	Texas
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	REM Sleep Medicine, Colorado Sleep Institute	Boulder	Colorado
United States	PAB Clinical Research	Brandon	Florida
United States	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Community Research Management Assoc.	Cincinnati	Ohio
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Houston Sleep Center	Houston	Texas
United States	Kentucky Research Group,	Louisville	Kentucky
United States	SleepMed of Central	Macon	Georgia
United States	Neurological Associate	Maplewood	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	NeuroCare Center for Sleep	Newton	Massachusetts
United States	Lynn Institute	Oklahoma City	Oklahoma
United States	Stanford Medicine Sleep Center	Palo Alto	California
United States	Wake Research Associates	Raleigh	North Carolina
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Clinical Research Group of St. Petersburg	Saint Petersburg	Florida
United States	Pacific Research Network	San Diego	California
United States	Swedish Medical Center	Seattle	Washington
United States	Empire Clinical Research	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Balance Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics (Cmax)	Pharmacokinetic parameters after multiple doses.; -Maximum serum concentration (Cmax)	Selected Days 14, 35, and 56
Other	Pharmacokinetics (Tmax)	Pharmacokinetic parameters after multiple doses.; -Time of maximum plasma concentration (Tmax)	Selected Days 14, 35, and 56
Other	Pharmacokinetics (T½)	Pharmacokinetic parameters after multiple doses.; -Elimination half life (T½)	Selected Days 1, 14, 31, 35, 42, and 56
Other	Pharmacokinetics (AUC)	Pharmacokinetic parameters after multiple doses.; -Area under the concentration time curve (AUC)	Selected Days 1, 14, 21, 35, 42, and 56
Primary	Efficacy Epworth Sleepiness Scale	Epworth Sleepiness Scale	After 14 days per treatment
Secondary	Efficacy Maintenance of Wakefulness Test	Maintenance of Wakefulness Test	After 14 days per treatment

External Links

•   ARISE Study Website