A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452239
• Other study ID #: 20007A
• Secondary ID: 2021-003049-40
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: March 11, 2025

Study information

• Verified date: June 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 570
• Est. completion date: March 11, 2025
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache
• Migraine
• Migraine Disorders
• Prescription Drug Overuse

Intervention

Drug:
• Eptinezumab
Solution for infusion
• Placebo
Solution for infusion

Locations

Country	Name	City	State
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Southern Neurology	Kogarah	New South Wales
Australia	Alfred Health	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg
Denmark	Danish Headache Center	Glostrup	Capital
France	Hospices Civils de Lyon - Hôpital Pierre Wertheimer	Bron	Rhône
France	Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert	Clermont-Ferrand	Puy-de-Dôme
France	Hôpital Roger Salengro	Lille	Nord
France	Assistance Publique Hopitaux de Marseille	Marseille	Bouches-du-Rhône
France	CHU de Nice	Nice	Alpes-Maritimes
France	AP-HP - Hopital Lariboisiere	Paris
France	Groupe Hospitalier Paris Saint Joseph	Paris
France	Centre Hospitalier Annecy Genevois - Site d'Annecy	Pringy	Haute-Savoie
France	CHRU Nantes	Saint-Herblain	Loire-Atlantique
France	Centre Hospitalier Universitaire de Saint Etienne	Saint-Priest-en-Jarez	Loire
France	Hôpital Pierre-Paul Riquet	Toulouse	Haute-Garonne
Georgia	Aversi Clinic LTD	Tbilisi
Georgia	Ltd Israel-Georgia Medical Research Clinic Helsicore	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10	Tbilisi
Georgia	MediClubGeorgia Ltd	Tbilisi
Georgia	Multiprofile Clinic Consilium Medulla	Tbilisi
Georgia	Pineo Medical Ecosystem	Tbilisi
Georgia	S. Khechinashvili University Clinic, Ltd.	Tbilisi
Germany	Universitätsklinikum Carl Gustav Carus an der TU Dresden	Dresden	Sachsen
Germany	Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	Kopfschmerzzentrum Frankfurt	Frankfurt am Main	Hessen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101	Jena	Thüringen
Germany	Sindelfingen Clinics	Sindelfingen	Baden-Württemberg
Germany	Studienzentrum Nord-West	Westerstede	Niedersachsen
Italy	ASL 1 Abruzzo - PO Avezzano	Avezzano	Abruzzo
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico	Bari	Puglia
Italy	IRCCS Istituto delle Scienze Neurologiche - Largo B. Nigrisoli	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena
Italy	AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2	Palermo
Italy	Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS	Pavia
Italy	Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia	Perugia	Umbria
Italy	Fondazione Policlinico Universitario A Gemelli-Rome	Roma	Lazio
Italy	Fondazione Policlinico Universitario Campus Bio-Medico	Roma	Lazio
Italy	IRCCS San Raffaele	Roma	Lazio
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Norway	Haukeland Universitetssykehus	Bergen	Hordaland
Norway	Akershus Universitetssykehus	Nordbyhagen	Akershus
Norway	Oslo Universitetssykehus	Oslo
Norway	St. Olav's University Hospital	Trondheim	Sør-Trøndelag
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 Puerta del Mar	Cadiz
Spain	C.H. Regional Reina Sofia - PPDS	Cordoba
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario HM Sanchinarro - CIOCC	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Sweden	Hallands Sjukhus Halmstad	Halmstad	Hallands Lan
Sweden	Karolinska Universitetssjukhuset Huddinge	Huddinge	Stockholms Lan
Sweden	Skaneuro Privatmottagning	Lund	Skane Lan
Sweden	CTC Clinical Trial Consultants AB	Solna	Stockholms Lan
United States	Dent Neurologic Institute - Amherst	Amherst	New York
United States	Montefiore Headache Center - BRANY - PPDS	Bronx	New York
United States	Texas Center for Drug Development, Inc	Houston	Texas
United States	Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS	Marrero	Louisiana
United States	Clinvest - National Ave - Headlands - PPDS	Springfield	Missouri
United States	Clinical Research of Central Florida - ClinEdge - PPDS	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  Georgia,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Monthly Migraine Days (MMDs)		Baseline to Weeks 1-4
Secondary	Change From Baseline in MMDs		Weeks 1-12 and Weeks 13-24
Secondary	Change From Baseline in the Number of Monthly Headache Days (MHDs)		Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary	Change From Baseline in Average Daily Pain Assessment Score		Weeks 1-2, Weeks 13-24
Secondary	Change From Baseline in Monthly Days with Acute Medication Use		Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary	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
Secondary	Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH		Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary	Change From Baseline in MMDs with Acute Medication Use		Weeks 1-12 and Weeks 13-24
Secondary	Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)		Weeks 1-12 and Weeks 13-24
Secondary	Percentage of Participants with Migraine on the Day After Dosing		On the day after dosing
Secondary	Response: =50% Reduction From Baseline in MMDs		Baseline to Weeks 1-4 and Weeks 1-12
Secondary	Response: =75% Reduction From Baseline in MMDs		Baseline to Weeks 1-4 and Weeks 1-12
Secondary	Response: =50% Reduction From Baseline in MHDs		Baseline to Weeks 1-4 and Weeks 1-12
Secondary	Response: =75% Reduction From Baseline in MHDs		Baseline to Weeks 1-4 and Weeks 1-12
Secondary	Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity		Weeks 1-4 and Weeks 1-12
Secondary	Patient Global Impression of Change (PGIC) Score	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).	Week 4, Week 12, and Week 24
Secondary	Change in Most Bothersome Symptom (MBS) Score	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.	Weeks 1-12 and Weeks 13-24
Secondary	Change From Baseline in the Headache Impact Test (HIT-6) Total Score	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).	Week 4, Week 12, and Week 24
Secondary	Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score	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.	Baseline to Week 4, Week 12, and Week 24
Secondary	Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores	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)	Baseline to Week 4, Week 12, and Week 24
Secondary	Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score	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).	Baseline to Week 4, Week 12, and Week 24
Secondary	Change From Baseline in Health Care Resources Utilisation (HCRU) Score	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.	Baseline to Week 12 and Week 24
Secondary	Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores	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)	Baseline to Week 12 and Week 24
Secondary	Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores	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.	Baseline to Week 12 and Week 24
Secondary	Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score	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.	Baseline to Week 4, Week 12, and Week 24