Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-03 @ 6:23 AM
Study NCT ID:
NCT06358950
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D002385', 'term': 'Cataplexy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6', 'timeFrame': 'Baseline to Week 6'}], 'secondaryOutcomes': [{'measure': 'Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6', 'timeFrame': 'Baseline to Week 6', 'description': 'Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)'}, {'measure': 'Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary', 'timeFrame': 'Measured at Week 5 and 6'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 15 Weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Narcolepsy', 'Cataplexy', 'Orexin'], 'conditions': ['Narcolepsy Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://vibrancestudies.com/?utm_source=ClinicalTrials&utm_medium=Referral&utm_content=Listing&utm_campaign=Listing_Vibrance1', 'label': 'Vibrance-1 Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years of age\n* Has a BMI ≥18 and ≤40 kg/m2\n* Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:\n\n * Is HLA-DQB1\\*06:02-positive\n * Has residual excessive daytime sleepiness and cataplexy\n* Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study\n* Is willing to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator\n* Is currently pregnant, breastfeeding, or planning to become pregnant during the study\n* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT06358950', 'acronym': 'Vibrance-1', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1', 'orgStudyIdInfo': {'id': 'ALKS 2860-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 mg ALKS 2680', 'interventionNames': ['Drug: ALKS 2680']}, {'type': 'EXPERIMENTAL', 'label': '6 mg ALKS 2680', 'interventionNames': ['Drug: ALKS 2680']}, {'type': 'EXPERIMENTAL', 'label': '8 mg ALKS 2680', 'interventionNames': ['Drug: ALKS 2680']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALKS 2680', 'type': 'DRUG', 'description': 'Oral tablet of ALKS 2680 for once daily administration', 'armGroupLabels': ['4 mg ALKS 2680', '6 mg ALKS 2680', '8 mg ALKS 2680']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablet containing matching placebo for once daily administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigator Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80045', 'city': 'Aurora', 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