We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eptinezumab in Adults With Migraine and Medication Overuse Headache (Sunlight)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772742
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

Condition or disease Intervention/treatment Phase
Migraine Medication Overuse Headache Drug: Placebo Drug: Eptinezumab Phase 3

Detailed Description:

Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91 patients in the placebo group.

The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). Patient will receive investigational medicinal product (IMP) at the Baseline Visit with either eptinezumab or placebo by IV infusion and at week 12 visit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache
Actual Study Start Date : February 17, 2021
Actual Primary Completion Date : May 23, 2022
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Experimental: Eptinezumab

Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion

Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion

Drug: Eptinezumab
Eptinezumab - 100 mg, solution for infusion
Other Name: Lu AG09221

Placebo Comparator: Placebo

Double-Blind Treatment Phase (at baseline): Placebo by IV infusion

Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion

Drug: Placebo
Placebo - solution for infusion

Drug: Eptinezumab
Eptinezumab - 100 mg, solution for infusion
Other Name: Lu AG09221




Primary Outcome Measures :
  1. Change from baseline in the number of monthly migraine days (MMDs) [ Time Frame: Weeks 1-12 ]

Secondary Outcome Measures :
  1. Change from baseline in MMDs with use of acute medication [ Time Frame: Weeks 1-12 ]
  2. Response: ≥50% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
  3. Migraine rate on the day after dosing [ Time Frame: At Day 1 ]
  4. Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-4 ]
  5. Change from baseline in the number of monthly headache days (MHDs) [ Time Frame: Weeks 1-12 ]
  6. Response: ≥75% reduction from baseline in MMDs [ Time Frame: Weeks 1-12 ]
  7. Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-12 ]
  8. Response: ≥75% reduction from baseline in MHDs [ Time Frame: Weeks 1-4 ]
  9. Change from baseline in the number of MHDs with use of acute medication [ Time Frame: Weeks 1-12 ]
  10. Change from baseline in rate of migraines with severe pain intensity [ Time Frame: Weeks 1-12 ]
  11. Change from baseline in rate of headaches with severe pain intensity [ Time Frame: Weeks 1-12 ]
  12. Patient Global Impression of Change (PGIC) score [ Time Frame: At Week 12 ]
  13. Most Bothersome Symptom (MBS) (score as measured relative to Screening) [ Time Frame: At Week 12 ]
  14. Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score [ Time Frame: Baseline to Week 12 ]
  15. Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) [ Time Frame: Baseline to Week 12 ]
  16. Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score [ Time Frame: Baseline to Week 12 ]
  17. Health Care Resources Utilization (HCRU) [ Time Frame: Baseline to Week 12 ]
    Migraine-specific healthcare 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.

  18. Change from baseline to Week 12 in the Work Productivity and Activity impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment) [ Time Frame: Baseline to Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
  • The patient has ≥8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
  • The patient has a diagnosis of medication overuse headache (MOH) as defined by IHS ICHD-3 guidelines.
  • The patient has headache on ≥15 days/month for each month within the past 3 months prior to the Screening Visit.
  • The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for >3 months.
  • The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
  • The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
  • The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
  • The patient has had an onset of migraine at <50 years of age

Exclusion Criteria:

  • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
  • The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
  • The patient has a diagnosis of acute or active temporomandibular disorder.
  • The patient 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).
  • Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
  • The patient 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 in- and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772742


Locations
Show Show 40 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04772742    
Other Study ID Numbers: 19139A
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Secondary
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations