A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
- Conditions
- Medication Overuse HeadacheMigraine
- Interventions
- Drug: Placebo
- Registration Number
- NCT05452239
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eptinezumab Eptinezumab Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12. Placebo Eptinezumab Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12. Placebo Placebo Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Number of Monthly Migraine Days (MMDs) Baseline to Weeks 1-4
- Secondary Outcome Measures
Name Time Method Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics) Weeks 1-12 and Weeks 13-24 Response: ≥50% Reduction From Baseline in MMDs Baseline to Weeks 1-4 and Weeks 1-12 Response: ≥75% Reduction From Baseline in MHDs Baseline to Weeks 1-4 and Weeks 1-12 Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score Baseline to Week 4, Week 12, and Week 24 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.
Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH Weeks 1-4, Weeks 1-12, and Weeks 13-24 Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity Weeks 1-4 and Weeks 1-12 Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score Baseline to Week 4, Week 12, and Week 24 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).Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score Baseline to Week 4, Week 12, and Week 24 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.
Change From Baseline in the Number of Monthly Headache Days (MHDs) Weeks 1-4, Weeks 1-12, and Weeks 13-24 Response: ≥75% Reduction From Baseline in MMDs Baseline to Weeks 1-4 and Weeks 1-12 Response: ≥50% Reduction From Baseline in MHDs Baseline to Weeks 1-4 and Weeks 1-12 Patient Global Impression of Change (PGIC) Score Week 4, Week 12, and Week 24 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).
Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores Baseline to Week 4, Week 12, and Week 24 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)Change From Baseline in MMDs Weeks 1-12 and Weeks 13-24 Change From Baseline in Average Daily Pain Assessment Score Weeks 1-2, Weeks 13-24 Change From Baseline in Monthly Days with Acute Medication Use Weeks 1-4, Weeks 1-12, and Weeks 13-24 Percentage of Participants Not Fulfilling the International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Weeks 1-4, Weeks 1-12, and Weeks 13-24 Change From Baseline in MMDs with Acute Medication Use Weeks 1-12 and Weeks 13-24 Percentage of Participants with Migraine on the Day After Dosing On the day after dosing Change in Most Bothersome Symptom (MBS) Score Weeks 1-12 and Weeks 13-24 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.
Change From Baseline in the Headache Impact Test (HIT-6) Total Score Week 4, Week 12, and Week 24 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).
Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores Baseline to Week 12 and Week 24 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)
Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores Baseline to Week 12 and Week 24 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.Change From Baseline in Health Care Resources Utilisation (HCRU) Score Baseline to Week 12 and Week 24 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.
Trial Locations
- Locations (76)
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Alfred Health
🇦🇺Melbourne, Victoria, Australia
CHU de Nice
🇫🇷Nice, Alpes-Maritimes, France
Azienda Ospedaliero Universitaria Consorziale Policlinico
🇮🇹Bari, Puglia, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Umbria, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
🇮🇹Modena, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
🇮🇹Palermo, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Italy
Leids Universitair Medisch Centrum
🇳🇱Leiden, Zuid-Holland, Netherlands
Akershus Universitetssykehus
🇳🇴Nordbyhagen, Akershus, Norway
Haukeland Universitetssykehus
🇳🇴Bergen, Hordaland, Norway
St. Olav's University Hospital
🇳🇴Trondheim, Sør-Trøndelag, Norway
Oslo Universitetssykehus
🇳🇴Oslo, Norway
Hospital Puerta del Mar
🇪🇸Cadiz, Cádiz, Spain
C.H. Regional Reina Sofia - PPDS
🇪🇸Cordoba, Córdoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro - CIOCC
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hallands Sjukhus Halmstad
🇸🇪Halmstad, Hallands Lan, Sweden
Skaneuro Privatmottagning
🇸🇪Lund, Skane Lan, Sweden
Karolinska Universitetssjukhuset Huddinge
🇸🇪Huddinge, Stockholms Lan, Sweden
Clinvest - National Ave - Headlands - PPDS
🇺🇸Springfield, Missouri, United States
Texas Center for Drug Development, Inc
🇺🇸Houston, Texas, United States
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Danish Headache Center
🇩🇰Glostrup, Capital, Denmark
Sydvestjysk Sygehus Esbjerg
🇩🇰Esbjerg, Denmark
Hôpital Pierre-Paul Riquet
🇫🇷Toulouse, Haute-Garonne, France
Centre Hospitalier Annecy Genevois - Site d'Annecy
🇫🇷Pringy, Haute-Savoie, France
Centre Hospitalier Universitaire de Saint Etienne
🇫🇷Saint-Priest-en-Jarez, Loire, France
Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert
🇫🇷Clermont-Ferrand, Puy-de-Dôme, France
Pineo Medical Ecosystem
🇬🇪Tbilisi, Georgia
S. Khechinashvili University Clinic, Ltd.
🇬🇪Tbilisi, Georgia
Kopfschmerzzentrum Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany
Dent Neurologic Institute - Amherst
🇺🇸Amherst, New York, United States
Clinical Research of Central Florida - ClinEdge - PPDS
🇺🇸Winter Haven, Florida, United States
Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS
🇺🇸Marrero, Louisiana, United States
Headache Center - Montefiore Medical Center - BRANY - PPDS
🇺🇸Bronx, New York, United States
Southern Neurology
🇦🇺Kogarah, New South Wales, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Hôpital Roger Salengro
🇫🇷Lille, Nord, France
AP-HP - Hopital Lariboisiere
🇫🇷Paris, France
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10
🇬🇪Tbilisi, Georgia
Multiprofile Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
CTC Clinical Trial Consultants AB
🇸🇪Solna, Stockholms Lan, Sweden
Assistance Publique Hopitaux de Marseille
🇫🇷Marseille, Bouches-du-Rhône, France
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2
🇮🇹Napoli, Campania, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Lazio, Italy
CHRU Nantes
🇫🇷Saint-Herblain, Loire-Atlantique, France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
🇫🇷Bron, Rhône, France
Aversi Clinic LTD
🇬🇪Tbilisi, Georgia
MediClubGeorgia Ltd
🇬🇪Tbilisi, Georgia
Klinikverbund Südwest - Kliniken Sindelfingen
🇩🇪Sindelfingen, Baden-Württemberg, Germany
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, France
Ltd Israel-Georgia Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
Universitätsklinikum Carl Gustav Carus an der TU Dresden
🇩🇪Dresden, Sachsen, Germany
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
🇩🇪Jena, Thüringen, Germany
ASL 1 Abruzzo - PO Avezzano
🇮🇹Avezzano, Abruzzo, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
🇮🇹Roma, Lazio, Italy
Studienzentrum Nord-West
🇩🇪Westerstede, Niedersachsen, Germany
IRCCS Istituto delle Scienze Neurologiche - Largo B. Nigrisoli
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
IRCCS San Raffaele
🇮🇹Roma, Lazio, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy