Eptinezumab
DrugConcentrate for solution for infusion
Other names: Vyepti
NCT Number: NCT05164172
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.
Interested in participating?
Request Info6 year–17 year
All sexes
Interventional
Phase 3
Hospital Privado de La Comunidad, Mar del Plata, Buenos Aires, Argentina
This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Concentrate for solution for infusion
Other names: Vyepti
Time frame: Baseline up to Week 44
Time frame: Baseline, Weeks 8, 12, 24, 36, and 44
Time frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Time frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Time frame: Baseline, Weeks 12, 24, and 36
Contact information is provided by the study sponsor or research team.
H. Lundbeck A/S
Industry
Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Acronym: REJOIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07645924
Brain Diseases, Central Nervous System Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT05125302
Brain Diseases, Central Nervous System Diseases
Huntsville, Alabama, United States
View Trial DetailsNCT06972056
Brain Diseases, Central Nervous System Diseases
Flagstaff, Arizona, United States
View Trial DetailsNCT07720765
Alzheimer Disease, Autoimmune Diseases
Milan, Milano, Italy
View Trial Details