Brief Summary
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.
Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.
Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.
Brief Title
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
Detailed Description
The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Medication Overuse Headache
Eligibility Criteria
Inclusion Criteria:
* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has had an onset of migraine diagnosis at ≤50 years of age.
Exclusion Criteria:
* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
* The participant has a diagnosis of acute or active temporomandibular disorders.
* The participant 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).
* The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
* The participant 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.
* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has had an onset of migraine diagnosis at ≤50 years of age.
Exclusion Criteria:
* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
* The participant has a diagnosis of acute or active temporomandibular disorders.
* The participant 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).
* The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
* The participant 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.
Inclusion Criteria
Inclusion Criteria:
* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has had an onset of migraine diagnosis at ≤50 years of age.
inclusion and
* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has had an onset of migraine diagnosis at ≤50 years of age.
inclusion and
Gender
All
Gender Based
false
Keywords
Eptinezumab
Migraine
Medication overuse headache
Brief educational intervention
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT05452239
Org Class
Industry
Org Full Name
H. Lundbeck A/S
Org Study Id
20007A
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache
Primary Outcomes
Outcome Measure
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Outcome Time Frame
Baseline to Weeks 1-4
Secondary Ids
Secondary Id
2021-003049-40
Secondary Outcomes
Outcome Time Frame
Weeks 1-12 and Weeks 13-24
Outcome Measure
Change From Baseline in MMDs
Outcome Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Outcome Measure
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Outcome Time Frame
Weeks 1-2, Weeks 13-24
Outcome Measure
Change From Baseline in Average Daily Pain Assessment Score
Outcome Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Outcome Measure
Change From Baseline in Monthly Days with Acute Medication Use
Outcome Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Outcome Measure
Percentage of Participants Not Fulfilling the International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM)
Outcome Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Outcome Measure
Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH
Outcome Time Frame
Weeks 1-12 and Weeks 13-24
Outcome Measure
Change From Baseline in MMDs with Acute Medication Use
Outcome Time Frame
Weeks 1-12 and Weeks 13-24
Outcome Measure
Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)
Outcome Time Frame
On the day after dosing
Outcome Measure
Percentage of Participants with Migraine on the Day After Dosing
Outcome Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Outcome Measure
Response: ≥50% Reduction From Baseline in MMDs
Outcome Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Outcome Measure
Response: ≥75% Reduction From Baseline in MMDs
Outcome Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Outcome Measure
Response: ≥50% Reduction From Baseline in MHDs
Outcome Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Outcome Measure
Response: ≥75% Reduction From Baseline in MHDs
Outcome Time Frame
Weeks 1-4 and Weeks 1-12
Outcome Measure
Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity
Outcome Description
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse).
Outcome Time Frame
Week 4, Week 12, and Week 24
Outcome Measure
Patient Global Impression of Change (PGIC) Score
Outcome Description
Participants will identify a migraine-related symptom that is most bothersome for them. Participants will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity to sound.
Outcome Time Frame
Weeks 1-12 and Weeks 13-24
Outcome Measure
Change in Most Bothersome Symptom (MBS) Score
Outcome Description
The HIT-6 (v1.0) is a questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from "never" to "always" with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score and ranges from 36 to 78. The life impact derived from the total score is described as followed: Severe (≥60), Substantial (56 59), Some (50-55), Little to None (≤49).
Outcome Time Frame
Week 4, Week 12, and Week 24
Outcome Measure
Change From Baseline in the Headache Impact Test (HIT-6) Total Score
Outcome Description
The mMIDAS is a self-reporting questionnaire designed to assess absenteeism (complete disability) and presenteeism (reduced participation) in several domains, including work, school, family, social, and leisure activities. The total number of days with disability is rated on a 4-point scale, from the lower total score that indicates a Little or No Disability; Mild Disability; Moderate Disability to the higher total score that indicates a Severe Disability.
Outcome Time Frame
Baseline to Week 4, Week 12, and Week 24
Outcome Measure
Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score
Outcome Description
The MSQ v2.1 is designed to assess the quality of life in participants with migraine.
It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores are summed and transformed to a 0-to-100-point scale.
Higher scores indicate better quality of life. Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores are summed and transformed to a 0-to-100-point scale.
Higher scores indicate better quality of life. Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
Outcome Time Frame
Baseline to Week 4, Week 12, and Week 24
Outcome Measure
Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores
Outcome Description
The EQ-5D-5L42 is a patient-reported assessment designed to measure the participant's wellbeing.
It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome Time Frame
Baseline to Week 4, Week 12, and Week 24
Outcome Measure
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Outcome Description
Migraine-specific health care 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.
Outcome Time Frame
Baseline to Week 12 and Week 24
Outcome Measure
Change From Baseline in Health Care Resources Utilisation (HCRU) Score
Outcome Description
The WPAI is designed to provide a quantitative measure of the work productivity and activity impairment due to a specific health problem (WPAI:M). The WPAI:M assesses activities over the preceding 7 days and consists of 6 items: 1 item assess employment status, 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons, and 2 visual numerical scales to assess how much the participant's condition affects their productivity at work and their ability to complete normal daily activities. Sub-scores: (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
Outcome Time Frame
Baseline to Week 12 and Week 24
Outcome Measure
Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores
Outcome Description
The HADS is a patient-rated scale designed to screen for anxiety and depressive states in non-psychiatric participants. The HADS consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity).
The score of each sub-scale ranges from 0 to 21 and are analysed separately.
The score of each sub-scale ranges from 0 to 21 and are analysed separately.
Outcome Time Frame
Baseline to Week 12 and Week 24
Outcome Measure
Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores
Outcome Description
The TSQM-9 is a generic questionnaire assessing the participants satisfaction with the medication. The tool consists of 9 items addressing effectiveness, side effects, convenience, and overall satisfaction of the study drug.
Outcome Time Frame
Baseline to Week 4, Week 12, and Week 24
Outcome Measure
Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jelena Pavlovic
Investigator Email
jpavlovi@montefiore.org