Recruiting

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)

I5Q-MC-CGAT - ClinicalTrials.gov - NCT04616326

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age.
How long will I be in the trial?
The study will last about 77 weeks and may include up to 18 visits.
Email
Recruiting

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (REBUILD-2)

I5Q-MC-CGAT - ClinicalTrials.gov - NCT04616326

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age.
How long will I be in the trial?
The study will last about 77 weeks and may include up to 18 visits.
Email

Key Requirements

Age :

12-17

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

12-17

Sex

All

Participants must

Patients must have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month

Participants must NOT

Participants must not be allergic to multiple drugs or certain types of drugs sometimes used for headaches

Participants must not have a history of persistent headaches every day or cluster headaches

Participants must not have a history of head or neck injury that was associated with the start of migraine headaches or a change in the nature of their headaches

Participants must not have a history of brain tumors or birth defects of the brain

Trial Summary

Conditions the trial is for

Pediatric Migraine, Migraine

What the trial is testing?

Galcanezumab

Could I receive a Placebo?

yes

Enrollment Goal

300

Trial Dates

November 2020 - March 2024

Trial Phase

3

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Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

12-17

Sex

All

Participants must

Patients must have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month

Participants must NOT

Participants must not be allergic to multiple drugs or certain types of drugs sometimes used for headaches

Participants must not have a history of persistent headaches every day or cluster headaches

Participants must not have a history of head or neck injury that was associated with the start of migraine headaches or a change in the nature of their headaches

Participants must not have a history of brain tumors or birth defects of the brain

Trial Summary

Conditions the trial is for

Pediatric Migraine, Migraine

What the trial is testing?

Galcanezumab

Could I receive a Placebo?

yes

Enrollment Goal

300

Trial Dates

November 2020 - March 2024

Trial Phase

3

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?