Sunrise: Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04921384

Collaborator

(none)

513

Enrollment

Locations

Arms

26.1

Anticipated Duration (Months)

9.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the efficacy of eptinezumab to prevent migraine in patients with chronic migraine

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

Detailed Description

This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in patients with chronic migraine who are eligible for preventive treatment.

Patients will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo.

Patients in Japan will continue in a separate extension study. For patients outside Japan, the double-blind, placebo-controlled treatment period will be followed by an extension period where all patients will receive active treatment to further assess the safety and tolerability of eptinezumab.

The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 24 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), and a Safety Follow-up Period (8 weeks).

For patients outside Japan, the total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks) and a Safety Follow-up Period (8 weeks).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

513 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

Actual Study Start Date :

May 29, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptinezumab 300 mg Double-Blind Treatment Phase (at baseline): 300 mg eptinezumab by intravenous (IV) infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.	Drug: Eptinezumab Eptinezumab - solution for infusion, intravenously Other Names: Lu AG09221
Experimental: Eptinezumab 100 mg Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.	Drug: Eptinezumab Eptinezumab - solution for infusion, intravenously Other Names: Lu AG09221
Placebo Comparator: Placebo Double-Blind Treatment Phase (at baseline): Placebo by IV infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.	Drug: Placebo Placebo - 100 mL of 0.9% normal saline, intravenously Drug: Eptinezumab Eptinezumab - solution for infusion, intravenously Other Names: Lu AG09221

Arm

Intervention/Treatment

Experimental: Eptinezumab 300 mg

Double-Blind Treatment Phase (at baseline): 300 mg eptinezumab by intravenous (IV) infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.

Drug: Eptinezumab

Eptinezumab - solution for infusion, intravenously

Other Names:

Lu AG09221

Experimental: Eptinezumab 100 mg

Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.

Drug: Eptinezumab

Eptinezumab - solution for infusion, intravenously

Other Names:

Lu AG09221

Placebo Comparator: Placebo

Double-Blind Treatment Phase (at baseline): Placebo by IV infusion. For patients outside Japan, at week 12: 100 or 300 eptinezumab by IV infusion.

Drug: Placebo

Placebo - 100 mL of 0.9% normal saline, intravenously

Drug: Eptinezumab

Eptinezumab - solution for infusion, intravenously

Other Names:

Lu AG09221

Outcome Measures

Primary Outcome Measures

Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12) [Weeks 1-12]

Secondary Outcome Measures

Response: ≥50% reduction from baseline in MMDs (Weeks 1-12) [Weeks 1-12]
Response: ≥75% reduction from baseline in MMDs (Weeks 1-4) [Weeks 1-4]
Response: ≥75% reduction from baseline in MMDs, (Weeks 1-12) [Weeks 1-12]
Migraine rate on the day after dosing [Day 1]
Response: ≥50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12) [Weeks 1-12]
Change from baseline in the number of MHDs (Weeks 1-12) [Weeks 1-12]
Response: ≥75% reduction from baseline in MHDs (Weeks 1-4) [Weeks 1-4]
Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12) [Weeks 1-12]
Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12) [Weeks 1-12]
Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12) [Weeks 1-12]
Patient Global Impression of Change (PGIC) score at week 12 [Week 12]
Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening [Screening to Week 12]
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score [Baseline to Week 12]
Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) [Baseline to Week 12]
Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score [Baseline to Week 12]
Health Care Resources Utilization (HCRU) [Baseline to Week 12]
Migraine-specific healthcare resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays.
Change from baseline to Week 12 in the Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment) [Baseline to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit.
The patient has a migraine onset at ≤50 years of age.
The patient has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
The patient fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
Migraine occurring on ≥8 days and headache occurring on ≥15 to ≤26 days.
The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
The patient is aged ≥18 (≥20 for Taiwan) and ≤75 years at the Screening Visit.

Exclusion Criteria:

The patient has received any medication targeting the calcitonin gene-related peptide (CGRP) pathway as preventive treatment of migraine.
The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
The patient has a diagnosis of acute or active temporomandibular disorder.
The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
The patient has a lifetime history of psychosis, bipolar mania, or dementia.
Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
2	Beijing Chaoyang Hospital Capital Medical University	Beijing		China	100020
3	Xuanwu Hospital Capital Medical University	Beijing		China	100053
4	Chinese PLA General Hospital	Beijing		China	100853
5	Renmin Hospital of Wuhan University	Beijing		China	430060
6	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Beijing		China	610041
7	The First Hospital of Jilin University	Changchun		China	130021
8	The Second Hospital of Jilin University	Changchun		China	130022
9	The First Affiliated Hospital of Chongqing Medical University	Chongqing		China	400016
10	The Affiliated Hospital of Guizhou Medical University	Guiyang		China	550000
11	Jiangxi Pingxiang People's Hospital	Pingxiang		China	337055
12	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan		China	430022
13	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China	710061
14	People's Hospital of Zhengzhou	Zhengzhou		China	450003
15	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450052
16	Pineo Medical Ecosystem	Tbilisi		Georgia	0114
17	Aversi Clinic LTD	Tbilisi		Georgia	0160
18	Iwate Medical University Uchimaru Medical Center	Morioka	Iwate	Japan	020-8505
19	Sendai Headache and Cranial Nerves Clinic	Sendai-Shi Taihaku-Ku	Miyagi	Japan	982-0014
20	Saitama Neuropsychiatric Institute	Saitama-shi	Saitama	Japan	338-8577
21	Moriyama Neurological Center Hospital	Edogawa-ku	Tokyo	Japan	134-0085
22	Nagamitsu Clinic	Hofu	Yamaguti	Japan	7470802
23	DOI Clinic Internal Medicine	Hirosima Naka-ku		Japan	730-0031
24	Atsuchi Neurosurgery Hospital	Kagoshima-shi		Japan	892-0842
25	Ikeda Neurosurgery	Kasuga City		Japan	816-0824
26	Jinnouchi Neurosurgery Clinic	Kasuga-shi		Japan	816-0802
27	Shin Matsudakai Atago Hospital	Kochi-shi		Japan	780-0051
28	Tatsuoka Neurology Clinic	Kyoto Shimojo-ku		Japan	680-8811
29	Dokkyo Medical University Hospital	Mibu-Machi		Japan	321-0293
30	Mito Kyodo General Hospital	Mito-shi		Japan	310-0015
31	Tominaga Hospital	Naniwa-ku		Japan	5560017
32	Tokyo headache clinic	Shibuya-ku		Japan	151-0051
33	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi		Japan	420-0853
34	Toyota Memorial Hospital	Toyota-shi		Japan	471-8513
35	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggido	Korea, Republic of	10380
36	Chungnam National University Hospital	Daejeon		Korea, Republic of	35015
37	Hallym University Dongtan Sacred Heart Hospital	Gyeonggi-do		Korea, Republic of	18450
38	Nowon Eulji Medical Center, Eulji University	Seoul		Korea, Republic of	01830
39	Seoul National University Hospital	Seoul		Korea, Republic of	03080
40	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181
41	Severance Hospital Yonsei University Health System - PPDS	Seoul		Korea, Republic of	03722
42	Asan Medical Center - PPDS	Seoul		Korea, Republic of	05505
43	Samsung Medical Center - PPDS	Seoul		Korea, Republic of	06351
44	Hospital Universitario Vall d'Hebron - PPDS	Barcelona		Spain	8035
45	Hospital Universitario La Paz - PPDS	Madrid		Spain	28046
46	Hospital Universitario HM Sanchinarro - CIOCC	Madrid		Spain	28050
47	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
48	Hospital Universitario Virgen del Rocio - PPDS	Sevilla		Spain	41013
49	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
50	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
51	Hospital Clinico Universitario de Valladolid	Valladolid		Spain	47005
52	Hospital Clinico Universitario Lozano Blesa	Zaragoza		Spain	50009
53	Taipei Veterans General Hospital	Taipei City		Taiwan	11217
54	Tri-Service General Hospital	Taipei		Taiwan	11490
55	Chang Gung Memorial Hospital, Linkou	Taoyuan City		Taiwan	33305

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT04921384

Other Study ID Numbers:

19140A

First Posted:

Jun 10, 2021

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Study Results

No Results Posted as of Jul 15, 2022