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Migraine DisorderPhase 3PREVAILNCT02985398

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

A Phase 3 study testing ALD403 (Eptinezumab) in people with Migraine Disorder, run by Alder Biopharmaceuticals, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Disorder
What is being tested?
ALD403 (Eptinezumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
20 sitesUnited States
Study dates
Dec 2016to Mar 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Research Site

    Bellevue, Washington, 98007

  • Massachusetts

    Boston, Massachusetts, 02131

  • Research Site

    Bradenton, Florida, 34201

  • Research Site

    Brooklyn, New York, 11229

  • Research Site

    Chattanooga, Tennessee, 37421

  • Research Site

    Colorado Springs, Colorado, 80918

  • Research Site

    Dayton, Ohio, 45432

  • Research Site

    DeLand, Florida, 32720

  • Research Site

    Fort Worth, Texas, 76104

  • Massachusetts

    Miami, Florida, 33125

  • Research Site

    Minneapolis, Minnesota, 55402

  • Research Site

    Mt. Pleasant, South Carolina, 29464

  • Research Site

    North Attleboro, Massachusetts, 02760

  • Research Site

    Prairie Village, Kansas, 66206

  • Research Site

    Rochester, New York, 14609

  • Research Site

    San Diego, California, 92108

  • Research Site

    Santa Monica, California, 90404

  • Research Site

    Tampa, Florida, 33634

  • 02481

    Wellesley, Massachusetts, 02481

  • Research Site

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: 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

Being tested
ALD403 (Eptinezumab)
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALD403 (Eptinezumab)Biological

    Also called Eptinezumab-jjmr, Vyepti

Study groups in NCT02985398
Study groupRoleWhat they receive
ALD403 (Eptinezumab) Dose Level 1ExperimentalALD403 (Eptinezumab) Dose Level 1 (IV)
Receives: Biological: ALD403 (Eptinezumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)

    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.

    Measured: 104 Weeks

  2. Number of Participants With a Clinically Significant Electrocardiogram

    Overall investigator interpretation of participant electrocardiogram

    Measured: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104

  3. Number of Participants With Any Clinically Significant Laboratory Values

    Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.

    Measured: 104 Weeks

  4. Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)

    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.

    Measured: 104 Weeks

  5. Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs

    Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator

    Measured: 104 Weeks

Secondary outcomes (8)

  1. Patient Global Impression of Change (PGIC) at 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.

    Measured: Week 104

  2. Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores

    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.

    Measured: Baseline to Week 12

  3. Health Related Quality of Life (EQ-5D-5L) at 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.

    Measured: Week 12

  4. Change in Baseline of Headache Impact Test (HIT-6) Score

    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.

    Measured: Baseline, Week 1-4, Week 9-12

  5. Change in Most Bothersome Symptom at 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.

    Measured: Baseline to Week 48

  6. Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score

    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.

    Measured: Baseline to Week 12

  7. Development of Anti-ALD403 Antibody by Visit

    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.

    Measured: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104

  8. Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit

    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.

    Measured: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionApr 2018
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985398
Sponsor's protocol ID
ALD403-CLIN-013
Acronym
PREVAIL
Status last verified
Apr 2020
First submitted
5 Dec 2016
Last updated
21 Apr 2020
Data monitoring committee
No

Publications

  • Starling AJ, Kudrow D, Kapur N, Awad SF, Grossman SW, Patel F, Ailani J, Blumenfeld A, Lipton RB. Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial. Pain Ther. 2026 Jun;15(3):785-801. doi: 10.1007/s40122-026-00831-0. Epub 2026 Apr 17.

    PubMed 41996064

  • Blumenfeld A, Ettrup A, Hirman J, Ebert B, Cady R. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022 Jul 8;22(1):251. doi: 10.1186/s12883-022-02774-3.

    PubMed 35804294

  • Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.

    PubMed 33781209

  • Kudrow D, Cady RK, Allan B, Pederson SM, Hirman J, Mehta LR, Schaeffler BA. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021 Mar 19;21(1):126. doi: 10.1186/s12883-021-02123-w.

    PubMed 33740902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALD403 (Eptinezumab) in people with Migraine Disorder, run by Alder Biopharmaceuticals, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) (time frame: 104 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985398, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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