Clinical trial NCT06810505: A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
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 Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Migraine
Keywords: Migraine
Chronic Migraine
Atogepant
QULIPTA
AQUIPTA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 420
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.

Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.

Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.

Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
* During the last 28 days of the screening/baseline period, and as per eDiary:

  * Participant must have completed the eDiary for a minimum of 20 out of 28 days.
  * Participant has \>= 15 headache days.
  * Participant has \>= 8 migraine days.

Exclusion Criteria:

* Clinically significant hypertension per investigator's judgment.
* History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 16 weeks
measure: Change From Baseline in Mean Monthly Migraine Days
timeFrame: Baseline (Week 0) through Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Monthly Headache Days
timeFrame: Baseline (Week 0) through Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days
timeFrame: Baseline (Week 0) through Week 12
measure: Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days
timeFrame: Baseline (Week 0) through Week 12
measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score
timeFrame: Baseline (Week 0) through Week 12
measure: Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
timeFrame: Baseline (Week 0) through Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services /ID# 270782
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 270389
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 270419
state: Arkansas
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 271048
state: California
city: Oceanside
country: United States
facility: Excell Research /ID# 270258
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research /ID# 270431
state: California
city: Miami
country: United States
facility: My Preferred Research /ID# 270312
state: Florida
city: Evansville
country: United States
facility: Deaconess Midtown Hospital /ID# 270572
state: Indiana
city: Ridgeland
country: United States
facility: Proven Endpoints LLC /ID# 270269
state: Mississippi
city: Papillion
country: United States
facility: Cct Research - Papillion Research Center /ID# 270393
state: Nebraska
city: Nashua
country: United States
facility: Healthy Perspectives - Innovate Mental Health Services /ID# 270847
state: New Hampshire
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst /ID# 270260
state: New York
city: Scottdale
country: United States
facility: Frontier Clinical Research - Scottdale /ID# 270854
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research - Smithfield /ID# 270849
state: Pennsylvania
city: Nashville
country: United States
facility: Access Clinical Trials Inc /ID# 270280
state: Tennessee
city: Houston
country: United States
facility: Earle Research /ID# 270424
state: Texas
city: Waxahachie
country: United States
facility: Clinpoint Trials /ID# 270261
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research /ID# 270259
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 270281
state: Utah
city: Kingwood
country: United States
facility: Frontier Clinical Research - Kingwood /ID# 271053
state: West Virginia
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 270486
state: Hyogo
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 270484
state: Kochi
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 270483
state: Osaka
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic /ID# 271610
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 270487
state: Tokyo
city: Tendo-shi
country: Japan
facility: Tendo Brain Clinic /ID# 271410
state: Yamagata
city: Kai
country: Japan
facility: Nagaseki Headache Clinic /ID# 271699
state: Yamanashi
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgery & Headache Clinic /ID# 271346
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: