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New treatment option for Migraine
Official title Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
ClinicalTrials.gov ID: NCT05125302
What this study is testing
What is Ubrogepant?
Ubrogepant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine.
Also referred to as Ubrelvy.
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
- Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children.
- 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
- A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3)...
- By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are...
- History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
- Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
- For main study participants, treatment of a qualifying migraine with partly blinded placebo during the screening period and completion of 2-hour...
You likely can't join if
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders...
- History of malignancy in the 5 years prior to Visit 1.
- History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of...
- Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to...
- At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
See the full eligibility criteria
- A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
- By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
- History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
- Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
- For main study participants, treatment of a qualifying migraine with partly blinded placebo during the screening period and completion of 2-hour headache pain assessment.
- Weight is ≥ 20 kg (44 pounds) and \< 135 kg (298 pounds)
- Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
- The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
- History of malignancy in the 5 years prior to Visit 1.
- History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.
- Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with...
- At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
- For main study participants, no headache at the 2-hour post dose assessment after taking partly blinded placebo for a qualifying migraine during screening period (ie, placebo responder).
- A current diagnosis of chronic migraine as defined by ICHD-3
- Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or...
- Difficulty distinguishing migraine headache from tension-type or other headaches.
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
- Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.
- Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication...
- Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway
- History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.
- Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Saraland, Alabama, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Glenwood, Arkansas, United States
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Fresno, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- San Diego, California, United States
- San Jose, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Winnetka, California, United States
- Aurora, Colorado, United States
- Centennial, Colorado, United States
- Colorado Springs, Colorado, United States
+ 90 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; Glendale, Arizona, United States; Phoenix, Arizona, United States; Glenwood, Arkansas, United States; Hot Springs, Arkansas, United States and 104 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.