Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05897320
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628361', 'term': 'eptinezumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 315}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12', 'timeFrame': 'Baseline, Weeks 1-12'}], 'secondaryOutcomes': [{'measure': 'Response: ≥50% Reduction From Baseline in MMDs', 'timeFrame': 'Baseline, Weeks 1-4 and Weeks 1-12'}, {'measure': 'Percentage of Participants with Migraine on the Day After Dosing (Day 1)', 'timeFrame': 'On Day After Dosing'}, {'measure': 'Change From Baseline in MMDs with Acute Medication Use', 'timeFrame': 'Baseline, Weeks 1-12'}, {'measure': 'Response: ≥75% reduction from baseline in MMDs', 'timeFrame': 'Baseline, Weeks 1-4 and Weeks 1-12'}, {'measure': 'Change From Baseline in the Number of Monthly Headache Days (MHDs)', 'timeFrame': 'Baseline, Weeks 1-12'}, {'measure': 'Change From Baseline in Monthly Hours with Headache', 'timeFrame': 'Baseline, Weeks 1-12'}, {'measure': 'Change From Baseline in Days with Acute Medication', 'timeFrame': 'Baseline, Weeks 1-12'}, {'measure': 'Change From Baseline in Rate of Migraines with Severe Pain Intensity', 'timeFrame': 'Baseline, Weeks 1-12'}, {'measure': 'Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Free Eptinezumab Plasma Concentrations', 'timeFrame': 'Day 0 (pre-dose) and at Weeks 8, 12, and 20'}, {'measure': 'Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])', 'timeFrame': 'Day 0 (pre-dose) and at Weeks 8, 12, and 20'}, {'measure': 'Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)', 'timeFrame': 'Day 0 (pre-dose) and at Weeks 8, 12, and 20'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Episodic Migraine']}, 'descriptionModule': {'briefSummary': 'The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.\n* During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.\n* During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.\n\nExclusion Criteria:\n\n* History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \\>60 min).\n* History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.\n* Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.\n* Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.\n\nOther inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05897320', 'acronym': 'PROSPECT-1', 'briefTitle': 'A Study of Eptinezumab in Pediatric Participants With Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine', 'orgStudyIdInfo': {'id': '19357A'}, 'secondaryIdInfos': [{'id': '2022-502538-14-00', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eptinezumab 300 mg', 'description': 'Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).', 'interventionNames': ['Drug: Eptinezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single IV infusion of matching placebo to eptinezumab.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Eptinezumab 100 mg', 'description': 'Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).', 'interventionNames': ['Drug: Eptinezumab']}], 'interventions': [{'name': 'Eptinezumab', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Eptinezumab 100 mg', 'Eptinezumab 300 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06905-1206', 'city': 'Stamford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ki Health Partners LLC DBA New England Institute for Clinical Research', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '32561-4495', 'city': 'Gulf Breeze', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Child Neurology of NW Florida', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '33012-3407', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'A G A Clinical Trials', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40508-1683', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kentucky HealthCare (UKHC) Kentucky Clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201-1544', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48104-5131', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Michigan Head Pain and Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11725-2808', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'North Suffolk Neurology-Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '28211-5027', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'OnSite Clinical Solutions, LLC - 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