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

Episodic Migraine Clinical Trial

— Kaleidoscope  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711394
• Other study ID #: M21-201
• Secondary ID: 2022-501100-94-0
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2023
• Est. completion date: May 4, 2028

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Atogepant is a medicine currently approved to treat adults with episodic 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.

Placebo, 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.

There 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 4, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).

• 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.

• Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.

• To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria:

• History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).

• Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).

• Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

• Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet
• Placebo-Matching Atogepant
Oral Tablet

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge /ID# 247201	Brugge
Belgium	Uza /Id# 247339	Edegem	Antwerpen
Canada	Stollery Children's Hospital /ID# 249672	Edmonton	Alberta
Canada	Montreal Children's Hospital /ID# 247271	Montreal	Quebec
Denmark	Aalborg Universitetshospital /Id# 247428	Aalborg	Nordjylland
Denmark	Herlev and Gentofte Hospital /ID# 247724	Herlev	Hovedstaden
Denmark	Regionshospitalet Godstrup /ID# 247902	Herning	Midtjylland
France	CHU Amiens-Picardie Site Sud /ID# 248833	Amiens CEDEX 1	Somme
France	Centre Hosp Intercommunal de Creteil /ID# 248832	Creteil	Val-de-Marne
France	CHU Toulouse - Hôpital des enfants /ID# 247553	Toulouse CEDEX 9
Hungary	Mind Klinika Kft. /ID# 248687	Budapest
Hungary	Semmelweis Egyetem /ID# 248360	Budapest
Israel	Shamir Medical Center /ID# 256857	Beer Ya'akov	HaMerkaz
Israel	Hillel Yaffe Medical Center /ID# 246747	Hadera	H_efa
Israel	Bnai Zion Medical Center /ID# 247469	Haifa	H_efa
Israel	The Chaim Sheba Medical Center /ID# 246746	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 247466	Tel Aviv	Tel-Aviv
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581	Milano
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 247638	Palermo
Japan	Konan Medical Center /ID# 254457	Kobe-shi	Hyogo
Japan	Umenotsuji Clinic /ID# 254453	Kochi-shi	Kochi
Japan	Tatsuoka Neurology Clinic /ID# 254455	Kyoto
Japan	Yamaguchi Clinic /ID# 254753	Nishinomiya	Hyogo
Japan	Tominaga Clinic /ID# 254450	Osaka-shi	Osaka
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211	Sendai-shi	Miyagi
Japan	Tokyo Medical University Hospital /ID# 254459	Shinjuku-ku	Tokyo
Netherlands	HagaZiekenhuis /ID# 247318	Den Haag
Netherlands	Canisius-Wilhelmina Ziekenhuis /ID# 253065	Nijmegen
Netherlands	ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301	Terneuzen
Poland	Athleticomed Sp. z o.o /ID# 248789	Bydgoszcz
Poland	Specjalistyczne Gabinety Sp. z o.o. /ID# 247384	Krakow	Malopolskie
Poland	Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382	Lublin	Lubelskie
Poland	Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247383	Poznan	Wielkopolskie
Poland	OHA-MED sp. z o.o /ID# 248614	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381	Wroclaw
Puerto Rico	Clinical Research Investigator Group, LLC /ID# 261254	Bayamon
Puerto Rico	Puerto Rico Health Institute /ID# 249741	Dorado
Puerto Rico	Caribbean Medical Research Center /ID# 251634	San Juan
Romania	Delta Health Care S.R.L /ID# 248130	Bucharest
Romania	Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431	Bucharest	Bucuresti
Romania	Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595	Cluj-Napoca	Cluj
Spain	Hospital Universitario Vall d'Hebron /ID# 247967	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 249267	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 248632	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 247969	Valencia
Sweden	Vastra Gotealandsregionen Regionhalsan /ID# 248277	Molnlycke
Sweden	Sodersjukhuset /ID# 248279	Stockholm
United Kingdom	NHS Grampian /ID# 249067	Aberdeen
United Kingdom	Stockport NHS foundation trust /ID# 261121	Stockport
United States	Dent Neurosciences Research Center, Inc. /ID# 248534	Amherst	New York
United States	Advanced Research Center /ID# 251381	Anaheim	California
United States	Michigan Headache & Neurological Institute (MHNI) /ID# 247468	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology /ID# 247470	Austin	Texas
United States	Pantheon Clinical Research /ID# 251601	Bountiful	Utah
United States	Coastal Georgia Child Neurology /ID# 249733	Brunswick	Georgia
United States	Patient Priority Clinical Sites, LLC /ID# 247535	Cincinnati	Ohio
United States	3A Research - East El Paso /ID# 248516	El Paso	Texas
United States	Core Clinical Research /ID# 249721	Everett	Washington
United States	Advanced Neurosciences Research, LLC /ID# 247592	Fort Collins	Colorado
United States	Office of Maria Ona /ID# 249738	Franklin	Virginia
United States	Earle Research /ID# 248501	Friendswood	Texas
United States	Headache Wellness Center /ID# 251018	Greensboro	North Carolina
United States	Northwest Florida Clinical Research Group, LLC /ID# 251382	Gulf Breeze	Florida
United States	Advanced Research Institute of Miami /ID# 248539	Homestead	Florida
United States	Rehabilitation & Neurological Services /ID# 248517	Huntsville	Alabama
United States	Sunwise Clinical Research /ID# 248529	Lafayette	California
United States	Preferred Research Partners /ID# 249729	Little Rock	Arkansas
United States	Alliance for Research - Long Beach /ID# 248521	Long Beach	California
United States	My Preferred Research LLC /ID# 249720	Miami	Florida
United States	Goryeb Children's Hospital /ID# 249724	Morristown	New Jersey
United States	Access Clinical Trials, Inc. /ID# 248532	Nashville	Tennessee
United States	Modern Migraine MD /ID# 258074	New York	New York
United States	Deaconess Clinic - Gateway Health Center /ID# 247589	Newburgh	Indiana
United States	Excell Research, Inc /ID# 247532	Oceanside	California
United States	Lynn Institute of Oklahoma City /ID# 247600	Oklahoma City	Oklahoma
United States	College Park Family Care Center Overland Park /ID# 249734	Overland Park	Kansas
United States	Cognitive Clinical Trials (CCT) - Papillion /ID# 248536	Papillion	Nebraska
United States	Proven Endpoints LLC /ID# 258066	Ridgeland	Mississippi
United States	Highland Clinical Research /ID# 247590	Salt Lake City	Utah
United States	Lumos Clinical Research Center /ID# 249731	San Jose	California
United States	Asclepes Research Centers - Spring Hill /ID# 248525	Spring Hill	Florida
United States	Family Psychiatry of The Woodlands /ID# 249727	The Woodlands	Texas
United States	ClinPoint Trials /ID# 248540	Waxahachie	Texas
United States	CincyScience /ID# 249726	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  France,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Puerto Rico,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Mean Monthly Migraine Days	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.	Baseline (Week 0) through Week 12
Secondary	Change from Baseline in Mean Monthly Headache Days	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.	Baseline (Week 0) through Week 12
Secondary	Change from Baseline in Mean Monthly Acute Medication Use Days	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.	Baseline (Week 0) through Week 12
Secondary	Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days	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.	Baseline (Week 0) to 3 Months
Secondary	Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score	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.	Baseline (Week 0) through Week 12
Secondary	Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score	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.	Baseline (Week 0) through Week 12

External Links

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