Trial record 2 of 16 for:
idiopathic hypersomnia
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (ARISE2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03542851 |
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Recruitment Status :
Active, not recruiting
First Posted : May 31, 2018
Last Update Posted : April 29, 2020
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Sponsor:
Balance Therapeutics
Information provided by (Responsible Party):
Balance Therapeutics
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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 |
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 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 |
Resource links provided by the National Library of Medicine
| 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. |
Primary Outcome Measures :
- 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 :
- 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).
- 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)
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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
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
| Study Director: | Morgan Lam | Chief Operating Officer |
| 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 |
| 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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Hypersomnolence, Idiopathic 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 |