Brief Summary
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
Brief Title
A 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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Idiopathic Hypersomnia
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT03542851
Org Class
Industry
Org Full Name
Balance Therapeutics
Org Study Id
BTD-001 IH202
Overall Status
Unknown status
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Primary Outcomes
Outcome Description
Measurements: IH Symptom Diary.
Outcome Measure
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
Outcome Time Frame
Change from baseline.
Secondary Outcomes
Outcome Description
Measurements: ESS (Epworth Sleepiness Scale).
Outcome Time Frame
Change from baseline.
Outcome Measure
The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.
Outcome Description
Measurements: MWT (Maintenance of Wakefulness Test)
Outcome Time Frame
Change from baseline.
Outcome Measure
The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Thorpy
Investigator Email
michael.thorpy@einsteinmed.org
Investigator Phone
718-920-4841