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New treatment option for Episodic Migraine
Official 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
ClinicalTrials.gov ID: NCT05711394
What this study is testing
What is Atogepant?
Atogepant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for episodic migraine.
Also referred to as QULIPTA, AGN-241689.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Saraland, Alabama, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Long Beach, California, United States
- Oceanside, California, United States
- San Jose, California, United States
- Walnut Creek, California, United States
- Fort Collins, Colorado, United States
- Gulf Breeze, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Spring Hill, Florida, United States
- Brunswick, Georgia, United States
- Newburgh, Indiana, United States
- Overland Park, Kansas, United States
- Ann Arbor, Michigan, United States
- Ridgeland, Mississippi, United States
- Papillion, Nebraska, United States
- Morristown, New Jersey, United States
+ 72 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Saraland, Alabama, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Long Beach, California, United States; Oceanside, California, United States and 86 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.