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A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants 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 : Completed
First Posted : November 5, 2019
Results First Posted : August 16, 2021
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.

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

Detailed Description:
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 participants who are candidates for preventive therapy. Participants 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 and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 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 7, 2019
Actual Primary Completion Date : July 8, 2020
Actual Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Eptinezumab
Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
Drug: Eptinezumab
Injection for IV administration

Placebo Comparator: Placebo
Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
Drug: Placebo
Injection for IV administration




Primary Outcome Measures :
  1. Time to Headache Pain Freedom [ Time Frame: Up to 48 hours postdose ]
    Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.

  2. Time to Absence of Most Bothersome Symptom (MBS) [ Time Frame: Up to 48 hours postdose ]
    Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).


Secondary Outcome Measures :
  1. Headache Pain Freedom at 2 Hours [ Time Frame: 2 hours ]
    Number of participants with freedom from headache pain at 2 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.

  2. Absence of MBS at 2 Hours [ Time Frame: 2 hours ]
    Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.

  3. Headache Pain Freedom at 4 Hours [ Time Frame: 4 hours ]
    Number of participants with freedom from headache pain at 4 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.

  4. Absence of MBS at 4 Hours [ Time Frame: 4 hours ]
    Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.

  5. Use of Rescue Medication Within the First 24 Hours [ Time Frame: Up to 24 hours postdose ]
    Rescue medication was defined as any medication to treat migraine or migraine-associated symptoms, which could have been provided to the participant any time after 2 hours post-start of infusion. Use of rescue medication was captured in the eDiary. Number of participants who used rescue medication up to 24 hours postdose are reported.



Information from the National Library of Medicine

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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:

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

Exclusion Criteria:

  • Unable to differentiate migraine from other headache or pain disorders.
  • 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
    5. devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections, spinal manipulation)
  • 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;
    2. triptans, ergotamines, or combination analgesics for 10 or more days per month;
    3. acetaminophen, aspirin or NSAIDs for 15 or more days per month (except if participant is taking 81 mg dose of aspirin for cardiac prophylaxis)
  • 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 (for example, diplopia, altered consciousness, or long duration).
  • Any changes to preventive migraine treatment(s) within 1 month prior to screening and up to treatment with the study drug (Day 0).
  • 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 treatment with study drug (Day 0).
  • 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 (Day 0).
  • Any use of systemic corticosteroid for migraine or any other reason within 3 months prior to treatment with study drug (Day 0).
  • Evidence or medical history of clinically significant psychiatric diseases that are uncontrolled and/or untreated.
  • 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
  Study Documents (Full-Text)

Documents provided by H. Lundbeck A/S:
Study Protocol  [PDF] July 1, 2020
Statistical Analysis Plan  [PDF] August 4, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Results First Posted: August 16, 2021
Last Update Posted: August 17, 2021
Last Verified: August 2021
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