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
Purpose
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 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. 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.
Condition
- Episodic Migraine
Eligibility
- Eligible Ages
- Between 6 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 (consistent with a diagnosis according to the ICHD-3 [2018]) 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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-Label PK Substudy: Atogepant Dose A (6-11 yrs) |
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. |
|
|
Experimental Open-Label PK Substudy: Atogepant Dose B (6-11 yrs) |
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. |
|
|
Experimental Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs) |
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks. |
|
|
Placebo Comparator Double-Blind Treatment Period: Placebo (12-17 yrs) |
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. |
|
|
Experimental Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs) |
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks. |
|
|
Experimental Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs) |
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks. |
|
|
Placebo Comparator Double-Blind Treatment Period: Placebo (6-11 yrs) |
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. |
|
|
Experimental Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs) |
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks. |
|
Recruiting Locations
Huntsville 4068590, Alabama 4829764 35805-4046
Saraland 4088628, Alabama 4829764 36571
Little Rock 4119403, Arkansas 4099753 72211
Anaheim 5323810, California 5332921 92805
Long Beach 5367929, California 5332921 90807
Oceanside 5378771, California 5332921 92056
Site Coordinator
760-758-2222
San Jose 5392171, California 5332921 95124-4108
Walnut Creek 5406990, California 5332921 94596
Gulf Breeze 4157634, Florida 4155751 32561-4495
Site Coordinator
850.934.1299
Homestead 4159050, Florida 4155751 33030-4613
Miami 4164138, Florida 4155751 33155
Brunswick 4184845, Georgia 4197000 31520-1601
Site Coordinator
770-376-7912
Newburgh 4262171, Indiana 4921868 47630
Site Coordinator
812-474-7184
Ann Arbor 4984247, Michigan 5001836 48104-5131
Site Coordinator
734-677-6000
Ridgeland 4443296, Mississippi 4436296 39157
Site Coordinator
601-790-1811
Papillion 5074792, Nebraska 5073708 68046-4131
Site Coordinator
402-979-8770
Morristown 5101427, New Jersey 5101760 07960
Amherst 5107129, New York 5128638 14226
Site Coordinator
716-558-5670
Greensboro 4469146, North Carolina 4482348 27405
Cincinnati 4508722, Ohio 5165418 45215-2123
Site Coordinator
513-791-7760
Cincinnati 4508722, Ohio 5165418 45229
Oklahoma City 4544349, Oklahoma 4544379 73112
Site Coordinator
405-447-8839
Philadelphia 4560349, Pennsylvania 6254927 19104-4319
Memphis 4641239, Tennessee 4662168 38103
Nashville 4644585, Tennessee 4662168 37203
Austin 4671654, Texas 4736286 78723-3079
Austin 4671654, Texas 4736286 78731
El Paso 5520993, Texas 4736286 79925-7945
Site Coordinator
915-598-8888
Friendswood 4692521, Texas 4736286 77546
Site Coordinator
281-218-8080
The Woodlands 4736476, Texas 4736286 77381
Waxahachie 4740328, Texas 4736286 75165-1430
Bountiful 5771826, Utah 5549030 84010-4968
Clinton 5773001, Utah 5549030 84015
Salt Lake City 5780993, Utah 5549030 84124
Franklin 4759986, Virginia 6254928 23851
Caguas 4563008, Puerto Rico 00727
Dorado 4564133, Puerto Rico 00646
Site Coordinator
787-797-1049
San Juan 4568127, Puerto Rico 00918-3501
More Details
- Status
- Recruiting
- Sponsor
- AbbVie