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A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

RecruitingPhase 3

Sponsor: H. Lundbeck A/S

Conditions: Migraine

Interventions: Eptinezumab

Countries: United States, Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

\- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion Criteria:

* The participant 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 ananaphylactic 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.

Locations (70)

New Haven, Connecticut, United States
Stamford, Connecticut, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Loxahatchee Groves, Florida, United States
Tampa, Florida, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
East Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Amherst, New York, United States
Commack, New York, United States
Charlotte, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Huntington, West Virginia, United States
Milwaukee, Wisconsin, United States
Mar del Plata, Buenos Aires, Argentina
Córdoba-Barrio Crisol, Córdoba Province, Argentina
Río Cuarto, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
Victoria, British Columbia, Canada
Ajax, Ontario, Canada
London, Ontario, Canada
Rome, Lazio, Italy
+ 40 more on CT.gov