search
Back to results

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

Primary Purpose

Migraine

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Eptinezumab
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study.
  • The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator.

Key Exclusion Criteria:

  • The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator.
  • The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator.
  • The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.

Other inclusion and exclusion criteria may apply.

Sites / Locations

  • DOI Clinic Internal Medicine
  • Jinnouchi Neurosurgery Clinic
  • Ikeda Neurosurgery
  • Mito Kyodo General Hospital
  • Iwate Medical University Uchimaru Medical Center
  • Atsuchi Neurosurgery Hospital
  • Shin Matsudakai Atago Hospital
  • Sendai Headache and Cranial Nerves Clinic
  • Saitama Neuropsychiatric Institute
  • Moriyama Neurological Center Hospital
  • Tokyo headache clinic
  • Nagamitsu Clinic
  • Tatsuoka Neurology Clinic
  • Dokkyo Medical University Hospital
  • Japanese Red Cross Shizuoka Hospital
  • Toyota Memorial Hospital
  • Tominaga Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eptinezumab

Arm Description

Participants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

Secondary Outcome Measures

Change From Baseline in the Number of Monthly Migraine Days
Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)
Change From Baseline in the Headache Impact Test (HIT-6) Score
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Patient Global Impression of Change (PGIC) Score
Change From Baseline in the Most Bothersome Symptom (MBS) Score

Full Information

First Posted
September 22, 2021
Last Updated
August 8, 2023
Sponsor
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT05064371
Brief Title
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
Official Title
Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.
Detailed Description
The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eptinezumab
Arm Type
Experimental
Arm Description
Participants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
Concentrate for solution for IV infusion
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Time Frame
From Baseline to Week 68
Secondary Outcome Measure Information:
Title
Change From Baseline in the Number of Monthly Migraine Days
Time Frame
Baseline, Week 60
Title
Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)
Time Frame
Baseline to Week 60
Title
Change From Baseline in the Headache Impact Test (HIT-6) Score
Time Frame
Baseline, Week 60
Title
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Time Frame
Baseline, Week 60
Title
Patient Global Impression of Change (PGIC) Score
Time Frame
Baseline to Week 60
Title
Change From Baseline in the Most Bothersome Symptom (MBS) Score
Time Frame
Baseline, Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study. The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator. Key Exclusion Criteria: The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator. The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator. The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
DOI Clinic Internal Medicine
City
Hiroshima-Shi Naka-Ku
State/Province
Hirosima
ZIP/Postal Code
730-0031
Country
Japan
Facility Name
Jinnouchi Neurosurgery Clinic
City
Kasuga-Shi
State/Province
Hukuoka
ZIP/Postal Code
816-0802
Country
Japan
Facility Name
Ikeda Neurosurgery
City
Kasuga-Shi
State/Province
Hukuoka
ZIP/Postal Code
816-0824
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center
City
Morioka-Shi
State/Province
Iwate
ZIP/Postal Code
020-0023
Country
Japan
Facility Name
Atsuchi Neurosurgery Hospital
City
Kagoshima-Shi
State/Province
Kagosima
ZIP/Postal Code
892-0842
Country
Japan
Facility Name
Shin Matsudakai Atago Hospital
City
Kochi
State/Province
Kôti
ZIP/Postal Code
780-0051
Country
Japan
Facility Name
Sendai Headache and Cranial Nerves Clinic
City
Sendai-Shi Taihaku-Ku
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Facility Name
Saitama Neuropsychiatric Institute
City
Saitama-Shi
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Facility Name
Moriyama Neurological Center Hospital
City
Edogawa-Ku
State/Province
Tokyo
ZIP/Postal Code
134-0085
Country
Japan
Facility Name
Tokyo headache clinic
City
Shibuya-Ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Facility Name
Nagamitsu Clinic
City
Hofu-Shi
State/Province
Yamaguti
ZIP/Postal Code
747-0802
Country
Japan
Facility Name
Tatsuoka Neurology Clinic
City
Kyoto Shimojo-ku
ZIP/Postal Code
680-8811
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Mibu-machi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Japanese Red Cross Shizuoka Hospital
City
Shizuoka-shi
ZIP/Postal Code
420-0853
Country
Japan
Facility Name
Toyota Memorial Hospital
City
Toyota-shi
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Tominaga Hospital
City
Osaka-Shi
State/Province
Ã"saka
ZIP/Postal Code
556-0017
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

We'll reach out to this number within 24 hrs