Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 9:44 PM
Study NCT ID:
NCT04923594
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'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': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ESS Score From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness.\n\nThe ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.'}], 'secondaryOutcomes': [{'measure': 'Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Narcolepsy', 'Excessive Daytime Sleepiness', 'Cataplexy Narcolepsy']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Males and females between 18 and 65 years of age, inclusive\n* Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria\n* Body mass index from 18 to 40 kg/m2, inclusive\n* Consent to use a medically acceptable method of contraception\n* Willing and able to provide written informed consent\n\nKey Exclusion Criteria:\n\n* Female subjects who are pregnant, nursing, or lactating\n* Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness\n* History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria\n* Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness\n* Use of any medications that could affect the evaluation of cataplexy\n* Received an investigational drug in the past 30 days or five half-lives (whichever is longer)'}, 'identificationModule': {'nctId': 'NCT04923594', 'briefTitle': 'Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NLS Pharmaceutics'}, 'officialTitle': 'A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy', 'orgStudyIdInfo': {'id': 'NLS-1021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NLS-2 (mazindol extended release)', 'description': '2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)', 'interventionNames': ['Drug: mazindol extended release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dosed orally, once daily for up to 4 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'mazindol extended release', 'type': 'DRUG', 'otherNames': ['NLS-2'], 'description': 'Dosed orally, once daily for up to 3 weeks', 'armGroupLabels': ['NLS-2 (mazindol extended release)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dosed orally, once daily for up to 4 weeks.', 'armGroupLabels': ['Placebo']}]}, '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 Center', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Francis Sleep Allergy and Lung Institute', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sleep Medicine Specialists of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ivetmar Medical Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'The Angel Medical Research Corporation', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '30315', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Treken Primary care', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Neuroscience Clinical Research Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center For Sleep & Wake Disorders', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '48314', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sleep and Attention Disorders', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Neurology and Sleep Disorders Clinic', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Sleep Specialists', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Superior Clinical Research, LLC', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'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': 'Intrepid Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dharma PA d/b/a Southwest Family Medicine Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Carlos Camozzi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NLS Pharmaceutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NLS Pharmaceutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}