Sunlight: Eptinezumab in Adults With Migraine and Medication Overuse Headache

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04772742

Collaborator

(none)

193

Enrollment

Locations

Arms

19.4

Anticipated Duration (Months)

4.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

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

Detailed Description

Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91 patients in the placebo group.

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 Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). Patient will receive investigational medicinal product (IMP) at the Baseline Visit with either eptinezumab or placebo by IV infusion and at week 12 visit.

Study Design

Study Type:

Interventional

Actual Enrollment :

193 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 the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache

Actual Study Start Date :

Feb 17, 2021

Actual Primary Completion Date :

May 23, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptinezumab Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion	Drug: Eptinezumab Eptinezumab - 100 mg, solution for infusion Other Names: Lu AG09221
Placebo Comparator: Placebo Double-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion	Drug: Placebo Placebo - solution for infusion Drug: Eptinezumab Eptinezumab - 100 mg, solution for infusion Other Names: Lu AG09221

Arm

Intervention/Treatment

Experimental: Eptinezumab

Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion

Drug: Eptinezumab

Eptinezumab - 100 mg, solution for infusion

Other Names:

Lu AG09221

Placebo Comparator: Placebo

Double-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion

Drug: Placebo

Placebo - solution for infusion

Drug: Eptinezumab

Eptinezumab - 100 mg, solution for infusion

Other Names:

Lu AG09221

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in MMDs with use of acute medication [Weeks 1-12]
Response: ≥50% reduction from baseline in MMDs [Weeks 1-12]
Migraine rate on the day after dosing [At Day 1]
Response: ≥75% reduction from baseline in MMDs [Weeks 1-4]
Change from baseline in the number of monthly headache days (MHDs) [Weeks 1-12]
Response: ≥75% reduction from baseline in MMDs [Weeks 1-12]
Response: ≥75% reduction from baseline in MHDs [Weeks 1-12]
Response: ≥75% reduction from baseline in MHDs [Weeks 1-4]
Change from baseline in the number of MHDs with use of acute medication [Weeks 1-12]
Change from baseline in rate of migraines with severe pain intensity [Weeks 1-12]
Change from baseline in rate of headaches with severe pain intensity [Weeks 1-12]
Patient Global Impression of Change (PGIC) score [At Week 12]
Most Bothersome Symptom (MBS) (score as measured relative to Screening) [At 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 migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
The patient has ≥8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
The patient has a diagnosis of medication overuse headache (MOH) as defined by IHS ICHD-3 guidelines.
The patient has headache on ≥15 days/month for each month within the past 3 months prior to the Screening Visit.
The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for >3 months.
The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
The patient has had an onset of migraine at <50 years of age

Exclusion Criteria:

The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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 in- 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	Beijing Anzhen Hospital, Capital Medical University	Beijing		China	100029
4	Peking University First Hospital	Beijing		China	100034
5	Xuanwu Hospital Capital Medical University	Beijing		China	100053
6	Peking Union Medical College Hospital	Beijing		China	100730
7	Chinese PLA General Hospital	Beijing		China	100853
8	The First Hospital of Jilin University	Changchun		China	130021
9	The Second Hospital of Jilin University	Changchun		China	130022
10	The First Affiliated Hospital of Chongqing Medical University	Chongqing		China	400016
11	The Affiliated Hospital of Guizhou Medical University	Guiyang		China	550000
12	Mianyang Central Hospital	Mianyang		China	621000
13	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing		China	610041
14	Jiangxi Pingxiang People's Hospital	Pingxiang		China	337055
15	People's Hospital of Rizhao	Rizhao		China	276826
16	Shengjing Hospital of China Medical University	Shenyang		China	110004
17	General Hospital of Northern Theater Command	Shenyang		China	110015
18	The University of Hong Kong - Shenzhen Hospital	Shenzhen		China	518053
19	Shanxi Provincial People Hospital	Taiyuan		China	030012
20	The 2nd Affiliated Hospital of Wenzhou Medical University	Wenzhou		China	325035
21	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan		China	430022
22	Renmin Hospital of Wuhan University	Wuhan		China	430060
23	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an		China	710061
24	People's Hospital of Zhengzhou	Zhengzhou		China	450003
25	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450052
26	Affiliated Hospital of Jiangsu University	Zhenjiang		China	212001
27	Pineo Medical Ecosystem	Tbilisi		Georgia	0114
28	Aversi Clinic LTD	Tbilisi		Georgia	0160
29	Nowon Eulji Medical Center, Eulji University	Seoul		Korea, Republic of	01830
30	Severance Hospital Yonsei University Health System - PPDS	Seoul		Korea, Republic of	03722
31	Samsung Medical Center - PPDS	Seoul		Korea, Republic of	06351
32	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid	Spain	28222
33	Hospital Universitario Vall d'Hebron - PPDS	Barcelona		Spain	8035
34	Hospital Universitario La Paz - PPDS	Madrid		Spain	28046
35	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
36	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
37	Hospital Clinico Universitario Lozano Blesa	Zaragoza		Spain	50009
38	Taipei Veterans General Hospital	Taipei City		Taiwan	11217
39	Tri-Service General Hospital	Taipei		Taiwan	11490
40	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:

NCT04772742

Other Study ID Numbers:

19139A

First Posted:

Feb 26, 2021

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Additional relevant MeSH terms:

Migraine Disorders

Headache Disorders, Secondary

Headache

Study Results

No Results Posted as of Aug 5, 2022