Authorised Therapeutic confirmatory (Phase III) Migraine

A study with eptinezumab in children and adolescents (6 to 17 years) with chronic or episodic migraine (REJOIN)

EU CTIS ID: 2022-502917-27-00

What this study is testing

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The patient must have completed Week 12 (completion) Visit of either Study 19356A (CM) or Study 19357A (EM) immediately prior to enrolment into this OLE study.

You likely can't join if

  • The patient has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
  • During lead-in Study19356A or Study19357A: - participant experienced anaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator. - the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later. - the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Canada
  • Turkey
  • United Kingdom
  • Serbia
  • Argentina
  • Mexico

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, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Canada; Turkey; United Kingdom; Serbia; Argentina and 1 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 EU CTIS; the study team decides eligibility.