Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-30 @ 8:54 PM
Study NCT ID:
NCT04451668
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2020-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study of FT218 in Subjects With Narcolepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D002385', 'term': 'Cataplexy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label treatment with FT218 (once nightly sodium oxybate extended release)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-related adverse events', 'timeFrame': '24 months', 'description': 'Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events'}, {'measure': 'Incidence of clinically significant changes in vital signs', 'timeFrame': '24 months', 'description': 'Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs'}, {'measure': 'Incidence of clinically significant changes in laboratory test results', 'timeFrame': '24 months', 'description': 'Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Narcolepsy', 'Cataplexy', 'Excessive Daytime Somnolence', 'Sleep Disorder', 'Sleep Disturbance', 'Sleep Wake Disorders']}, 'referencesModule': {'references': [{'pmid': '39263597', 'type': 'DERIVED', 'citation': 'Roy A, Stern T, Harsh J, Hudson JD, Ajayi AO, Corser BC, Mignot E, Santamaria A, Morse AM, Abaluck B, Ibrahim S, Schweitzer PK, Lancaster K, Dubow J, Gudeman J. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. Sleep Med X. 2024 Aug 15;8:100122. doi: 10.1016/j.sleepx.2024.100122. eCollection 2024 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy', 'detailedDescription': 'This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218 Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e., FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period, subjects who meet the entry criteria will be enrolled into the study. Subjects who completed the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will initiate FT218 treatment at a dose equivalent or closest to the total gram dose of twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and effectiveness as determined by the investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218\n* Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate\n* Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)\n* Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014)\n* Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.\n\nExclusion Criteria:\n\n* Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8\n* Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.)\n* A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.'}, 'identificationModule': {'nctId': 'NCT04451668', 'acronym': 'RESTORE', 'briefTitle': 'An Open Label Study of FT218 in Subjects With Narcolepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avadel'}, 'officialTitle': 'Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR', 'orgStudyIdInfo': {'id': 'CLFT218-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FT218', 'description': 'once nightly sodium oxybate extended release oral solution (FT218)', 'interventionNames': ['Drug: FT218']}], 'interventions': [{'name': 'FT218', 'type': 'DRUG', 'description': 'once nightly sodium oxybate extended release', 'armGroupLabels': ['FT218']}]}, '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': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Sleep Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'SDS Clinical Trials', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alpine Clinical Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Delta Waves, Inc.', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Disease Specialists, PA', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33176', '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': 'FL Pediatric Research Institute', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'SleepCare Research Institute, Inc. d/b/a Clinical Research Institute', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Helene A. Emsellem, MD PC', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital - Sleep Medicine and Research Center", 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Sleep-Wake Disorders Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Advanced Respiratory and Sleep Medicine', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sleep Management Institute Intrepid Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19355', 'city': 'Malvern', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Brian Abaluck Sleep Medicine', 'geoPoint': {'lat': 40.03622, 'lon': -75.51381}}, {'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': 'FutureSearch Trials of Neurology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229-4849', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Comprehensive Sleep Medicine Associates', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Northwest Houston Neurology', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '23188', 'city': 'Williamsburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'TPMG Clinical Research Williamsburg', 'geoPoint': {'lat': 37.2707, 'lon': -76.70746}}, {'zip': 'P2A 3A4', 'city': 'Parry Sound', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Perry Sound Health Center', 'geoPoint': {'lat': 45.34732, 'lon': -80.03527}}, {'zip': 'M5S 3A3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Jodha Tishon Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avadel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}