Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT03542851
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020177', 'term': 'Idiopathic Hypersomnia'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010433', 'term': 'Pentylenetetrazole'}], 'ancestors': [{'id': 'D001381', 'term': 'Azepines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary', 'timeFrame': 'Change from baseline.', 'description': 'Measurements: IH Symptom Diary.'}], 'secondaryOutcomes': [{'measure': 'The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.', 'timeFrame': 'Change from baseline.', 'description': 'Measurements: ESS (Epworth Sleepiness Scale).'}, {'measure': 'The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.', 'timeFrame': 'Change from baseline.', 'description': 'Measurements: MWT (Maintenance of Wakefulness Test)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Hypersomnia']}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or Females age 18 to 70 years old\n* Onset of hypersomnia between age 10 and 30 years of age\n* An Epworth Sleepiness Scale score of greater than or equal to 11\n* 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)\n* Females with a negative pregnancy test AND who are non-lactating\n* Sexually active females of childbearing potential must be willing to use a highly effective method of birth control\n* Sexually active males must have a vasectomy or use condoms\n\nExclusion Criteria:\n\n* History of any disorder causing hypersomnia other than IH\n* Evidence of circadian-rhythm disorder\n* Sleep apnea syndrome\n* Use of CPAP\n* Obese subjects with BMI greater than or equal to 35kg/m2\n* 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\n* Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior\n* Subjects who fail to wash out medications for IH or any other prohibited medications\n* Positive toxicology screen test during the Screening or Baseline Visits.\n* Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening\n* 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).\n* Participation in a clinical drug trial within 4 weeks of Screening Visit'}, 'identificationModule': {'nctId': 'NCT03542851', 'acronym': 'ARISE2', 'briefTitle': 'A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Balance Therapeutics'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia', 'orgStudyIdInfo': {'id': 'BTD-001 IH202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subject Receives BTD001 first', 'interventionNames': ['Drug: Pentetrazol (PTZ)', 'Drug: Placebo oral capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Subject Receives Placebo first', 'interventionNames': ['Drug: Pentetrazol (PTZ)', 'Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Pentetrazol (PTZ)', 'type': 'DRUG', 'otherNames': ['PTZ'], 'description': 'BTD-001 is an oral capsule of PTZ.', 'armGroupLabels': ['Subject Receives BTD001 first', 'Subject Receives Placebo first']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo will be presented as oral capsule.', 'armGroupLabels': ['Subject Receives BTD001 first', 'Subject Receives Placebo first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'SDS Clinical Trials', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92128', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Sleep Medicine Specialists of California', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'REM Sleep Medicine', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'PAB Clinical Research', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sleep Medicine Specialists of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Premier Research Institute', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Practicioners', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore Sleep Medicine', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurology', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Rowe Neurology Institute', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40218', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Research Group', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Sleep and Wake Disorders', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NeuroCare', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '48314', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sleep and Attention Disorders Institute', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Sleep Medicine and Research Center", 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University - Department of Neurology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Carolina of Huntersville', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '95242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Intrepid Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Consolidated Clinical Trials', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants, LLC', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Future Search Trials', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Sleep Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Morgan Lam', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Operating Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balance Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}