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

Phase 2

• Conditions: Idiopathic Hypersomnia
• Interventions: Drug: Pentetrazol (PTZ); Drug: Placebo oral capsule

• Registration Number: NCT03542851
• Lead Sponsor: Balance Therapeutics

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-18
• Study Start: 2018-05-29
• Study First Posted: 2018-05-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subject Receives Placebo first	Pentetrazol (PTZ)	-
Subject Receives BTD001 first	Pentetrazol (PTZ)	-
Subject Receives BTD001 first	Placebo oral capsule	-
Subject Receives Placebo first	Placebo oral capsule	-

Primary Outcome Measures

Name	Time	Method
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary	Change from baseline.	Measurements: IH Symptom Diary.

Secondary Outcome Measures

Name	Time	Method
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.	Change from baseline.	Measurements: ESS (Epworth Sleepiness Scale).
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.	Change from baseline.	Measurements: MWT (Maintenance of Wakefulness Test)

Trial Locations

Locations (32)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Hospital; 🇺🇸 Scottsdale, Arizona, United States

SDS Clinical Trials; 🇺🇸 Orange, California, 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

REM Sleep Medicine; 🇺🇸 Boulder, Colorado, United States

PAB Clinical Research; 🇺🇸 Brandon, Florida, United States

Sleep Medicine Specialists of South Florida; 🇺🇸 Miami, Florida, United States

Florida Premier Research Institute; 🇺🇸 Winter Park, Florida, United States

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