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An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)

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ClinicalTrials.gov Identifier: NCT02985398
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Study Description
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Brief Summary:
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Condition or disease Intervention/treatment Phase
Migraine Disorder Biological: ALD403 (Eptinezumab) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines
Actual Study Start Date : December 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
 Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 104 Weeks ]
    Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.

  2. Number of Participants With a Clinically Significant Electrocardiogram [ Time Frame: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104 ]
    Overall investigator interpretation of participant electrocardiogram

  3. Number of Participants With Any Clinically Significant Laboratory Values [ Time Frame: 104 Weeks ]
    Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.

  4. Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 104 Weeks ]
    Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.

  5. Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs [ Time Frame: 104 Weeks ]
    Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) at Week 104 [ Time Frame: Week 104 ]
    The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

  2. Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores [ Time Frame: Baseline to Week 12 ]
    The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement.

  3. Health Related Quality of Life (EQ-5D-5L) at Week 12 [ Time Frame: Week 12 ]
    The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.

  4. Change in Baseline of Headache Impact Test (HIT-6) Score [ Time Frame: Baseline, Week 1-4, Week 9-12 ]
    The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores.

  5. Change in Most Bothersome Symptom at Week 48 [ Time Frame: Baseline to Week 48 ]
    The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale.

  6. Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score [ Time Frame: Baseline to Week 12 ]

    The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability:

    0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability;

    A higher value represents a worse outcome.


  7. Development of Anti-ALD403 Antibody by Visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 ]
    Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months.

  8. Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 ]
    Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.

Exclusion Criteria:

  • Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
  • Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
  • Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
  • History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
Contacts and Locations
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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): NCT02985398


Locations
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United States, California
Research Site
San Diego, California, United States, 92108
Research Site
Santa Monica, California, United States, 90404
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80918
United States, Florida
Research Site
Bradenton, Florida, United States, 34201
Research Site
DeLand, Florida, United States, 32720
Massachusetts
Miami, Florida, United States, 33125
Research Site
Tampa, Florida, United States, 33634
Research Site
Winter Haven, Florida, United States, 33880
United States, Kansas
Research Site
Prairie Village, Kansas, United States, 66206
United States, Massachusetts
Massachusetts
Boston, Massachusetts, United States, 02131
Research Site
North Attleboro, Massachusetts, United States, 02760
02481
Wellesley, Massachusetts, United States, 02481
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, New York
Research Site
Brooklyn, New York, United States, 11229
Research Site
Rochester, New York, United States, 14609
United States, Ohio
Research Site
Dayton, Ohio, United States, 45432
United States, South Carolina
Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Research Site
Fort Worth, Texas, United States, 76104
United States, Washington
Research Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Alder Biopharmaceuticals, Inc.:
Study Protocol  [PDF] January 16, 2018
Statistical Analysis Plan  [PDF] February 5, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02985398    
Other Study ID Numbers: ALD403-CLIN-013
First Posted: December 7, 2016    Key Record Dates
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases