Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT05711394
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718987', 'term': 'atogepant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Mean Monthly Migraine Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Mean Monthly Headache Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.'}, {'measure': 'Change from Baseline in Mean Monthly Acute Medication Use Days', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.'}, {'measure': 'Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days', 'timeFrame': 'Baseline (Week 0) to 3 Months', 'description': 'A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.'}, {'measure': 'Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.'}, {'measure': 'Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score', 'timeFrame': 'Baseline (Week 0) through Week 12', 'description': 'The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Episodic Migraine', 'Atogepant', 'QULIPTA', 'AGN-241689'], 'conditions': ['Episodic Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M21-201', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.\n\nAtogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.\n\nPlacebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.\n\nThere may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight is \\>= 20 kg (44 lbs) and \\< 135 kg (298 lbs).\n* History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.\n* Participant has to have 4 to 14 migraine days and \\< 15 headache days in the 28-day baseline period per eDiary.\n* To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \\[2018\\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.\n\nExclusion Criteria:\n\n* History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).\n* Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).\n* Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).'}, 'identificationModule': {'nctId': 'NCT05711394', 'acronym': 'ATO EM PEDS', 'briefTitle': 'A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.', 'orgStudyIdInfo': {'id': 'M21-201'}, 'secondaryIdInfos': [{'id': '2022-501100-94-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)', 'description': 'Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)', 'description': 'Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)', 'description': 'Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: Placebo (12-17 yrs)', 'description': 'Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Placebo-Matching Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)', 'description': 'Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)', 'description': 'Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: Placebo (6-11 yrs)', 'description': 'Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Placebo-Matching Atogepant']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)', 'description': 'Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.', 'interventionNames': ['Drug: Atogepant']}], 'interventions': [{'name': 'Atogepant', 'type': 'DRUG', 'otherNames': ['QULIPTA', 'AGN-241689'], 'description': 'Oral Tablet', 'armGroupLabels': ['Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)', 'Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)', 'Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)', 'Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)', 'Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)', 'Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)']}, {'name': 'Placebo-Matching Atogepant', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Double-Blind Treatment Period: Placebo (12-17 yrs)', 'Double-Blind Treatment Period: Placebo (6-11 yrs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805-4046', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rehabilitation & Neurological Services /ID# 248517', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Preferred Research Partners /ID# 249729', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Preferred Research Partners /ID# 270406', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Research Center /ID# 251381', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90807', 'city': 'Long Beach', 'state': 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'RECRUITING', 'country': 'United States', 'facility': 'Headache Wellness Center /ID# 251018', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45215-2123', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '513-791-7760'}], 'facility': 'Patient Priority Clinical Sites, LLC /ID# 247535', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center /ID# 258070', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45069', 'city': 'West Chester', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'CincyScience /ID# 249726', 'geoPoint': {'lat': 39.33172, 'lon': -84.40716}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '405-447-8839'}], 'facility': 'Lynn Institute of Oklahoma City /ID# 247600', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Le Bonheur Children's Hospital /ID# 261084", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Access Clinical Trials, Inc. /ID# 248532', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78723-3079', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': "UT Health Austin at Dell Children's Neurology Clinic /ID# 264082", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 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{'zip': '2730', 'city': 'Herlev', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Herlev Hospital /ID# 247724', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '7400', 'city': 'Herning', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '+45 50935730'}], 'facility': 'Regionshospitalet Godstrup /ID# 247902', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '9000', 'city': 'Aalborg', 'state': 'North Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Aalborg Sygehus Nord /ID# 247428', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Somme', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Amiens-Picardie Site Sud /ID# 248833', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Val-de-Marne', 'status': 'RECRUITING', 'country': 'France', 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