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

April 10, 2020 updated by: Alder Biopharmaceuticals, Inc.

An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
104 Weeks
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
Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104
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.
104 Weeks
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.
104 Weeks
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
104 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 104
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.
Baseline to Week 12
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.
Week 12
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.
Baseline, Week 1-4, Week 9-12
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.
Baseline to Week 48
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.
Baseline to Week 12
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.
Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
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.
Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Biopharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD403-CLIN-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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