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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05452239




Registration number
NCT05452239
Ethics application status
Date submitted
6/07/2022
Date registered
11/07/2022
Date last updated
19/09/2024

Titles & IDs
Public title
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
Scientific 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
Secondary ID [1] 0 0
2021-003049-40
Secondary ID [2] 0 0
20007A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 0 0
Medication Overuse Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Mental Health 0 0 0 0
Addiction
Public Health 0 0 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eptinezumab
Treatment: Drugs - Placebo

Experimental: Eptinezumab - Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Placebo comparator: 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.


Treatment: Drugs: Eptinezumab
Solution for infusion

Treatment: Drugs: Placebo
Solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Timepoint [1] 0 0
Baseline to Weeks 1-4
Secondary outcome [1] 0 0
Change From Baseline in MMDs
Timepoint [1] 0 0
Weeks 1-12 and Weeks 13-24
Secondary outcome [2] 0 0
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Timepoint [2] 0 0
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary outcome [3] 0 0
Change From Baseline in Average Daily Pain Assessment Score
Timepoint [3] 0 0
Weeks 1-2, Weeks 13-24
Secondary outcome [4] 0 0
Change From Baseline in Monthly Days with Acute Medication Use
Timepoint [4] 0 0
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary outcome [5] 0 0
Percentage of Participants Not Fulfilling the International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM)
Timepoint [5] 0 0
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary outcome [6] 0 0
Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH
Timepoint [6] 0 0
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Secondary outcome [7] 0 0
Change From Baseline in MMDs with Acute Medication Use
Timepoint [7] 0 0
Weeks 1-12 and Weeks 13-24
Secondary outcome [8] 0 0
Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)
Timepoint [8] 0 0
Weeks 1-12 and Weeks 13-24
Secondary outcome [9] 0 0
Percentage of Participants with Migraine on the Day After Dosing
Timepoint [9] 0 0
On the day after dosing
Secondary outcome [10] 0 0
Response: =50% Reduction From Baseline in MMDs
Timepoint [10] 0 0
Baseline to Weeks 1-4 and Weeks 1-12
Secondary outcome [11] 0 0
Response: =75% Reduction From Baseline in MMDs
Timepoint [11] 0 0
Baseline to Weeks 1-4 and Weeks 1-12
Secondary outcome [12] 0 0
Response: =50% Reduction From Baseline in MHDs
Timepoint [12] 0 0
Baseline to Weeks 1-4 and Weeks 1-12
Secondary outcome [13] 0 0
Response: =75% Reduction From Baseline in MHDs
Timepoint [13] 0 0
Baseline to Weeks 1-4 and Weeks 1-12
Secondary outcome [14] 0 0
Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity
Timepoint [14] 0 0
Weeks 1-4 and Weeks 1-12
Secondary outcome [15] 0 0
Patient Global Impression of Change (PGIC) Score
Timepoint [15] 0 0
Week 4, Week 12, and Week 24
Secondary outcome [16] 0 0
Change in Most Bothersome Symptom (MBS) Score
Timepoint [16] 0 0
Weeks 1-12 and Weeks 13-24
Secondary outcome [17] 0 0
Change From Baseline in the Headache Impact Test (HIT-6) Total Score
Timepoint [17] 0 0
Week 4, Week 12, and Week 24
Secondary outcome [18] 0 0
Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score
Timepoint [18] 0 0
Baseline to Week 4, Week 12, and Week 24
Secondary outcome [19] 0 0
Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores
Timepoint [19] 0 0
Baseline to Week 4, Week 12, and Week 24
Secondary outcome [20] 0 0
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Timepoint [20] 0 0
Baseline to Week 4, Week 12, and Week 24
Secondary outcome [21] 0 0
Change From Baseline in Health Care Resources Utilisation (HCRU) Score
Timepoint [21] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [22] 0 0
Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores
Timepoint [22] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [23] 0 0
Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores
Timepoint [23] 0 0
Baseline to Week 12 and Week 24
Secondary outcome [24] 0 0
Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score
Timepoint [24] 0 0
Baseline to Week 4, Week 12, and Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2025
Actual
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Southern Neurology - Kogarah
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Alfred Health - Melbourne
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Denmark
State/province [6] 0 0
Capital
Country [7] 0 0
Denmark
State/province [7] 0 0
Esbjerg
Country [8] 0 0
France
State/province [8] 0 0
Alpes-Maritimes
Country [9] 0 0
France
State/province [9] 0 0
Bouches-du-Rhône
Country [10] 0 0
France
State/province [10] 0 0
Haute-Garonne
Country [11] 0 0
France
State/province [11] 0 0
Haute-Savoie
Country [12] 0 0
France
State/province [12] 0 0
Loire-Atlantique
Country [13] 0 0
France
State/province [13] 0 0
Loire
Country [14] 0 0
France
State/province [14] 0 0
Nord
Country [15] 0 0
France
State/province [15] 0 0
Puy-de-Dôme
Country [16] 0 0
France
State/province [16] 0 0
Rhône
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Georgia
State/province [18] 0 0
Tbilisi
Country [19] 0 0
Germany
State/province [19] 0 0
Baden-Württemberg
Country [20] 0 0
Germany
State/province [20] 0 0
Hessen
Country [21] 0 0
Germany
State/province [21] 0 0
Niedersachsen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Sachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Thüringen
Country [25] 0 0
Germany
State/province [25] 0 0
Greifswald
Country [26] 0 0
Italy
State/province [26] 0 0
Abruzzo
Country [27] 0 0
Italy
State/province [27] 0 0
Campania
Country [28] 0 0
Italy
State/province [28] 0 0
Emilia-Romagna
Country [29] 0 0
Italy
State/province [29] 0 0
Lazio
Country [30] 0 0
Italy
State/province [30] 0 0
Lombardia
Country [31] 0 0
Italy
State/province [31] 0 0
Puglia
Country [32] 0 0
Italy
State/province [32] 0 0
Toscana
Country [33] 0 0
Italy
State/province [33] 0 0
Umbria
Country [34] 0 0
Italy
State/province [34] 0 0
Modena
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Italy
State/province [36] 0 0
Pavia
Country [37] 0 0
Netherlands
State/province [37] 0 0
Zuid-Holland
Country [38] 0 0
Norway
State/province [38] 0 0
Akershus
Country [39] 0 0
Norway
State/province [39] 0 0
Hordaland
Country [40] 0 0
Norway
State/province [40] 0 0
Sør-Trøndelag
Country [41] 0 0
Norway
State/province [41] 0 0
Oslo
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Alicante
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Cadiz
Country [46] 0 0
Spain
State/province [46] 0 0
Cordoba
Country [47] 0 0
Spain
State/province [47] 0 0
Lleida
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
Spain
State/province [50] 0 0
Valladolid
Country [51] 0 0
Spain
State/province [51] 0 0
Zaragoza
Country [52] 0 0
Sweden
State/province [52] 0 0
Hallands Lan
Country [53] 0 0
Sweden
State/province [53] 0 0
Skane Lan
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholms Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05452239
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
Country 0 0
Phone 0 0
+45 36301311
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05452239