A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

Idiopathic Hypersomnia Clinical Trial

— ARISE2  

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03542851
• Other study ID #: BTD-001 IH202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 29, 2018
• Est. completion date: May 28, 2020

Study information

• Verified date: April 2020
• Source: Balance Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

Description:

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 28, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males or Females age 18 to 70 years old

• Onset of hypersomnia between age 10 and 30 years of age

• An Epworth Sleepiness Scale score of greater than or equal to 11

• Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)

• Females with a negative pregnancy test AND who are non-lactating

• Sexually active females of childbearing potential must be willing to use a highly effective method of birth control

• Sexually active males must have a vasectomy or use condoms

Exclusion Criteria:

• History of any disorder causing hypersomnia other than IH

• Evidence of circadian-rhythm disorder

• Sleep apnea syndrome

• Use of CPAP

• Obese subjects with BMI greater than or equal to 35kg/m2

• History of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures

• Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior

• Subjects who fail to wash out medications for IH or any other prohibited medications

• Positive toxicology screen test during the Screening or Baseline Visits.

• Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening

• History of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at Screening Visit and treated with a stable dose of medication for at least 3 months prior to the Baseline Visit).

• Participation in a clinical drug trial within 4 weeks of Screening Visit

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia

Intervention

Drug:
• Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
• Placebo oral capsule
Placebo will be presented as oral capsule.

Locations

Country	Name	City	State
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	Future Search Trials	Austin	Texas
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	REM Sleep Medicine	Boulder	Colorado
United States	PAB Clinical Research	Brandon	Florida
United States	St. Luke's Sleep Medicine and Research Center	Chesterfield	Missouri
United States	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Intrepid Research	Cincinnati	Ohio
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Geisinger	Danville	Pennsylvania
United States	Fort Wayne Neurology	Fort Wayne	Indiana
United States	Houston Sleep Center	Houston	Texas
United States	Research Carolina of Huntersville	Huntersville	North Carolina
United States	Rowe Neurology Institute	Lenexa	Kansas
United States	Kentucky Research Group	Louisville	Kentucky
United States	Sleep Practicioners	Macon	Georgia
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	Consolidated Clinical Trials	Monroeville	Pennsylvania
United States	Albert Einstein College of Medicine	New York	New York
United States	Columbia University - Department of Neurology	New York	New York
United States	NeuroCare	Newton	Massachusetts
United States	Northshore Sleep Medicine	Northbrook	Illinois
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	SDS Clinical Trials	Orange	California
United States	Neuroscience Center	Saint Paul	Minnesota
United States	Pacific Research Network	San Diego	California
United States	Sleep Medicine Specialists of California	San Ramon	California
United States	Santa Monica Clinical Trials	Santa Monica	California
United States	Mayo Clinic Hospital	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Sleep and Attention Disorders Institute	Sterling Heights	Michigan
United States	Florida Premier Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Balance Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary	Measurements: IH Symptom Diary.	Change from baseline.
Secondary	The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.	Measurements: ESS (Epworth Sleepiness Scale).	Change from baseline.
Secondary	The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.	Measurements: MWT (Maintenance of Wakefulness Test)	Change from baseline.