Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT06752668
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ORX750 in Participants With Narcolepsy and 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Up to Day 49'}, {'measure': 'Number of Participants With Abnormal Changes From Baseline in Laboratory Tests', 'timeFrame': 'Up to Day 49'}, {'measure': 'Number of Participants With Abnormal Change From Baseline in Vital Signs', 'timeFrame': 'Up to Day 49'}, {'measure': 'Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)', 'timeFrame': 'Up to Day 49'}, {'measure': 'Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to Day 49'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for ORX750', 'timeFrame': 'Day 1'}, {'measure': 'Tmax: Time of Maximum Concentration for ORX750', 'timeFrame': 'Days 1, 14 and 28'}, {'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750', 'timeFrame': 'Day 1'}, {'measure': 'Cmax,ss: Maximum Observed Concentration at Steady State for ORX750', 'timeFrame': 'Days 14 and 28'}, {'measure': 'AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750', 'timeFrame': 'Days 14 and 28'}, {'measure': 'Mean sleep latency (average of the first 4 trials) in the Maintenance of Wakefulness Test (MWT) for ORX750 versus placebo.', 'timeFrame': 'Baseline up to Day 42', 'description': 'Mean sleep latency is determined by averaging the time to falling asleep across trials'}, {'measure': 'Change From Baseline in Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Baseline up to Day 41'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Narcolepsy Type 1', 'Narcolepsy Type 2', 'Idiopathic Hypersomnia']}, 'descriptionModule': {'briefSummary': 'Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \\[EDS\\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities.\n\nWhile all conditions result in feeling sleepy, there are some differences in other common symptoms:\n\n* NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night.\n* NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy.\n* IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up.\n\nOrexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. ORX750 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* BMI ≥17 and ≤37 kg/m2\n* Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria\n* Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia\n* Is willing and able to adhere to additional protocol requirements\n\nExclusion Criteria:\n\n* A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).\n* Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT06752668', 'acronym': 'CRYSTAL-1', 'briefTitle': 'A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centessa Pharmaceuticals plc'}, 'officialTitle': 'A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)', 'orgStudyIdInfo': {'id': 'ORX750-0201'}, 'secondaryIdInfos': [{'id': '2024-518929-15-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Narcolepsy Type 1: ORX750 and Placebo', 'interventionNames': ['Drug: ORX750', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Narcolepsy Type 2: ORX750 and Placebo', 'interventionNames': ['Drug: ORX750', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Idiopathic Hypersomnia: ORX750 and Placebo', 'interventionNames': ['Drug: ORX750', 'Drug: Placebo']}], 'interventions': [{'name': 'ORX750', 'type': 'DRUG', 'description': 'ORX750 capsule.', 'armGroupLabels': ['Idiopathic Hypersomnia: ORX750 and Placebo', 'Narcolepsy Type 1: ORX750 and Placebo', 'Narcolepsy Type 2: ORX750 and Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'ORX750 matching placebo capsule.', 'armGroupLabels': ['Idiopathic Hypersomnia: ORX750 and Placebo', 'Narcolepsy Type 1: ORX750 and Placebo', 'Narcolepsy Type 2: ORX750 and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36832', 'city': 'Auburn', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Auburn, Alabama', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Chandler, Arizona', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85253', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Scottsdale, Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90805', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Long Beach, California', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Santa Ana, California', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Brandon, Florida', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Miami, Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 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'San Antonio, Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'M5S 3A3', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Toronto, Ontario', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Centessa Pharmaceuticals', 'role': 'CONTACT', 'email': 'CRYSTAL-1@centessa.com', 'phone': '+1 617-468-5770'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centessa Pharmaceuticals (UK) Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}