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A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (ARISE2)

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ClinicalTrials.gov Identifier: NCT03542851
Recruitment Status : Active, not recruiting
First Posted : May 31, 2018
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Balance Therapeutics

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

Condition or disease Intervention/treatment Phase
Idiopathic Hypersomnia Drug: Pentetrazol (PTZ) Drug: Placebo oral capsule Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 28, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Subject Receives BTD001 first Drug: Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
Other Name: PTZ

Drug: Placebo oral capsule
Placebo will be presented as oral capsule.
Experimental: Subject Receives Placebo first Drug: Pentetrazol (PTZ)
BTD-001 is an oral capsule of PTZ.
Other Name: PTZ

Drug: Placebo oral capsule
Placebo will be presented as oral capsule.


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary [ Time Frame: Change from baseline. ]
    Measurements: IH Symptom Diary.


Secondary Outcome Measures :
  1. The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures. [ Time Frame: Change from baseline. ]
    Measurements: ESS (Epworth Sleepiness Scale).

  2. The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures. [ Time Frame: Change from baseline. ]
    Measurements: MWT (Maintenance of Wakefulness Test)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542851


Locations
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Sponsors and Collaborators
Balance Therapeutics
Investigators
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Study Director: Morgan Lam Chief Operating Officer
More Information
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Responsible Party: Balance Therapeutics
ClinicalTrials.gov Identifier: NCT03542851    
Other Study ID Numbers: BTD-001 IH202
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Idiopathic Hypersomnia
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Pentylenetetrazole
 Convulsants
Central Nervous System Stimulants
Physiological Effects of Drugs
GABA Antagonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action