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Evaluate Efficacy & Safety of Eptinezumab Administered Intravenously in Subjects Experiencing Acute Attack of Migraine (RELIEF)

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: NCT04152083
Recruitment Status : Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those patients who are candidates for preventive therapy. Subjects will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.

Condition or disease Intervention/treatment Phase
Migraine Biological: Eptinezumab Biological: Placebo Phase 3

Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in subjects experiencing an acute attack of migraine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Eptinezumab
Subjects will receive a single dose of 100 mg eptinezumab (IV)
Biological: Eptinezumab
Subjects will receive a single dose of 100 mg eptinezumab (IV)

Placebo Comparator: Placebo (IV)
Participants will receive placebo matched to a single dose of 100 mg of eptinezumab given IV
Biological: Placebo
Participants will receive placebo matched to a single dose of 100mg of eptinezumab given IV




Primary Outcome Measures :
  1. Time to headache pain freedom Time to headache pain freedom [ Time Frame: 48 hours ]
    First timepoint post start of infusion at which subject reports freedom of pain meaning their headache pain has gone from moderate to severe at baseline to no pain with no administration of rescue medications.

  2. Time to absence of most bothersome symptom [ Time Frame: 48 hours ]
    First timepoint post start of infusion at which the subject reports absence of most bothersome symptoms with no administration of rescue medications.


Secondary Outcome Measures :
  1. Proportion of patients with headache pain freedom at 2 hours [ Time Frame: 2 hours ]
    Headache pain freedom at 2 hours post start of infusion.

  2. Proportion of patients with absence of most bothersome symptom at 2 hours [ Time Frame: 2 hours ]
    Absence of most bothersome symptom at 2 hours post start of infusion.



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.


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

Inclusion Criteria:

  1. Greater than 1-year history of migraine, with or without aura, with onset of first migraine before age 50
  2. Migraine on 4 - 15 days per month in the 3 months prior to screening.
  3. Headache free for at least 24 hours prior to onset of a qualifying migraine.

Exclusion Criteria:

  1. Unable to differentiate migraine from other headache or pain disorders.
  2. Use of the following medication, for any indication, within the 24-hour period prior to dosing with study drug:

    1. Triptans, ergotamines and ergot-derivatives
    2. Analgesics (including but not limited to acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs [NSAIDs], combination analgesics, caffeine-containing analgesics and opioids/narcotics) and other acute migraine medication(s)
    3. Antiemetic medications (including but not limited to prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide)
    4. Antihistamines (except if required to treat allergic reactions)
    5. Any form of magnesium intended for acute treatment of migraine
    6. Devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections, spinal manipulation)
  3. Use of the following medication, for any indication, in each of the 3 months prior to screening:

    1. opioids/narcotics or butalbital containing products (including combinations) on more than 4 days per month; OR
    2. triptans, ergotamines, or combination analgesics for 10 or more days per month; OR c) acetaminophen, aspirin or nonsteroidal anti-inflammatory drugs [NSAIDs] for 15 or more days per month (except if subject is taking 81 mg dose of aspirin for cardiac prophylaxis)
  4. 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), ophthalmoplegic migraine and migraine with neurological accompaniments that are not typical of migraine aura (e.g., diplopia, altered consciousness, or long duration).
  5. Any changes to preventive migraine treatment(s) within 1 month prior to screening.
  6. Any use of approved devices, neuromodulation, neurostimulation or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections) within the 24-hour period prior to dosing with study drug.
  7. Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 7 days prior to treatment with study drug.
  8. Any use of systemic corticosteroid for migraine or any other reason within 3 months prior to treatment with study drug.
  9. Evidence or medical history of clinically significant psychiatric diseases that are uncontrolled and/or untreated.
  10. Receipt of any monoclonal antibody treatment, for migraine or any other indication, (within or outside a clinical study) within 6 months prior to screening.

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): NCT04152083


Locations
Show Show 57 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Alder Biopharmaceuticals, Inc.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04152083    
Other Study ID Numbers: ALD403-CLIN-015
18903A ( Other Identifier: H. Lundbeck A/S )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases