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

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05164172
• Collaborator: (none)
• Enrollment: 610
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 152.5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Eptinezumab	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 610 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptinezumab 300 mg Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.	Drug: Eptinezumab; Concentrate for solution for infusion; Other Names: Vyepti
Experimental: Eptinezumab 100 mg Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.	Drug: Eptinezumab; Concentrate for solution for infusion; Other Names: Vyepti

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events [Baseline up to Week 44]

Secondary Outcome Measures

1. Free Eptinezumab Plasma Concentration [Baseline, Weeks 8, 12, 24, 36, and 44]

2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [Baseline (Week 0), Weeks 8, 12, 24, 36, and 44]

3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) [Baseline (Week 0), Weeks 8, 12, 24, 36, and 44]

4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36 [Baseline, Weeks 12, 24, and 36]

5. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

6. Change From Baseline in Monthly Migraine Days Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

7. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 [Baseline, Weeks 1-12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Axcess Medical Research	Loxahatchee Groves	Florida	United States	33470-9272
2	Dent Neurosciences Research Center Incorporated	Amherst	New York	United States	14226-1727
3	Centro de Investigaciones Médicas Tucuman	San Miguel de Tucuman	Tucuman	Argentina	T4000AXL
4	Hospital de Niños de La Santisima Trinidad	Cordoba		Argentina

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT05164172
• Other Study ID Numbers: 19379A; 2020-001649-38
• First Posted: Dec 20, 2021
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Aug 18, 2022