Clinical Trials List
Protocol Number19139A
NCT Number(ClinicalTrials.gov Identfier)NCT04772742
2020-10-01 - 2022-08-14
Phase III
Recruiting3
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
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Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
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Sponsor
H. Lundbeck A/S
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- YEN-FENG WANG Division of Neurology
- 陳韋達 Division of Neurology
- Hung-Yu Liu Division of Neurology
- 陳世彬 Division of Neurology
- 賴冠霖 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Linkou Chang Gung Medical Foundation
Taiwan National PI
羅榮昇
Co-Principal Investigator
- 朱俊哲 Division of Neurology
- 張國軒 Division of Neurology
- 呂榮國 Division of Neurology
- Hong-Chou Kuo Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Migraine,Medication Overuse Headache
Objectives
This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache
Test Drug
Eptinezumab
Active Ingredient
Eptinezumab
Dosage Form
injection
Dosage
100 mg/mL
Endpoints
Primary Outcome Measures :
Change from baseline in the number of monthly migraine days (MMDs) [ Time Frame: Weeks 1-12 ]
Secondary Outcome Measures :
Change from baseline in MMDs with use of acute medication [ Time Frame: Weeks 1-12 ]
Response: ≥50% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
Migraine rate on the day after dosing [ Time Frame: At Day 1 ]
Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-4 ]
Change from baseline in the number of monthly headache days (MHDs) [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-4 ]
Change from baseline in the number of MHDs with use of acute medication [ Time Frame: Weeks 1-12 ]
Change from baseline in rate of migraines with severe pain intensity [ Time Frame: Weeks 1-12 ]
Change from baseline in rate of headaches with severe pain intensity [ Time Frame: Weeks 1-12 ]
Patient Global Impression of Change (PGIC) score [ Time Frame: At Week 12 ]
Most Bothersome Symptom (MBS) (score as measured relative to Screening) [ Time Frame: At Week 12 ]
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline to Week 12 ]
Health Care Resources Utilization (HCRU) [ Time Frame: 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) [ Time Frame: Baseline to Week 12 ]
Change from baseline in the number of monthly migraine days (MMDs) [ Time Frame: Weeks 1-12 ]
Secondary Outcome Measures :
Change from baseline in MMDs with use of acute medication [ Time Frame: Weeks 1-12 ]
Response: ≥50% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
Migraine rate on the day after dosing [ Time Frame: At Day 1 ]
Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-4 ]
Change from baseline in the number of monthly headache days (MHDs) [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-12 ]
Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-4 ]
Change from baseline in the number of MHDs with use of acute medication [ Time Frame: Weeks 1-12 ]
Change from baseline in rate of migraines with severe pain intensity [ Time Frame: Weeks 1-12 ]
Change from baseline in rate of headaches with severe pain intensity [ Time Frame: Weeks 1-12 ]
Patient Global Impression of Change (PGIC) score [ Time Frame: At Week 12 ]
Most Bothersome Symptom (MBS) (score as measured relative to Screening) [ Time Frame: At Week 12 ]
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline to Week 12 ]
Health Care Resources Utilization (HCRU) [ Time Frame: 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) [ Time Frame: Baseline to Week 12 ]
Inclution Criteria
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
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
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
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
The Estimated Number of Participants
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Taiwan
20 participants
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Global
182 participants
