A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 … (NCT04458857) | Clinical Trial Compass
CompletedPhase 3
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
United States, Canada, Finland235 participantsStarted 2020-07-15
Plain-language summary
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab.
The total duration of the study is planned to be up to 51 months.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).
* The participant or parent/caregiver maintain a prospectively collected headache diary
* The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as \<4 headache-free days during the 28-day baseline period.
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria:
* The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
* The participant or parent/caregiver maintain a prospectively collected headache diary
* The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
* The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug
Timeframe: Baseline (Day -28 to Day -1), up to Week 12
Trial details
NCT IDNCT04458857
SponsorTeva Branded Pharmaceutical Products R&D, Inc.