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

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Chronic Migraine

Treatments: Drug: Atogepant; Drug: Placebo for Atogepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06810505

2024-513836-28 (Other Identifier)

M23-712

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

420 participants in 2 patient groups, including a placebo group

Atogepant

Experimental group

Description:

Participants will receive atogepant once daily for 12 weeks.

Treatment:

Drug: Atogepant

Placebo for Atogepant

Placebo Comparator group

Description:

Participants will receive placebo for atogepant once daily for 12 weeks.

Treatment:

Drug: Placebo for Atogepant