Clinical trial NCT05452239: A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Medication Overuse Headache
Keywords: Eptinezumab
Migraine
Medication overuse headache
Brief educational intervention
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

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