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CompletedNCT02559895PROMISE 1Updated May 14, 2020Results posted

A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

A Phase 3 interventional study of ALD403 and Placebo in Migraine Disorders, sponsored by Alder Biopharmaceuticals, Inc.. Completed at 87 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Alder Biopharmaceuticals, Inc. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
898
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.

02

Conditions studied

  • Migraine Disorders

Browse trials for

03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 898 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Alder Biopharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

  • History of migraine ≥ 12 months with

    • ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
    • During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary
  • No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization
  • Headache eDiary was completed on at least 25 of the 28 days prior to randomization

Exclusion criteria

Exclusion Criteria:

  • Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia
  • Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening
  • History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
  • Unable to differentiate migraine from other headaches
  • Have any clinically significant concurrent medical condition
  • Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
  • Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
898 participants (actual)

Study arms

  • Experimental
    ALD403 Dose Level 1

    ALD403 Dose Level 1 (IV)

    Drug: ALD403

  • Experimental
    ALD403 Dose Level 2

    ALD403 Dose Level 2 (IV)

    Drug: ALD403

  • Experimental
    ALD403 Dose Level 3

    ALD403 Dose Level 3 (IV)

    Drug: ALD403

  • Placebo comparator
    Placebo

    Placebo (IV)

    Drug: Placebo

Interventions

  • DrugALD403

    Also known as: Eptinezumab-jjmr, Vyepti

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Change From Baseline in Monthly Migraine Days (Weeks 1-12)

    Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

    Time frame: Week 1-12

Secondary outcomes

  1. 75% Migraine Responder Rate

    Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

    Time frame: Week 1-12

  2. 75% Migraine Responder Rate

    Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.

    Time frame: Week 1-4

  3. 50% Migraine Responder Rate

    Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline

    Time frame: Week 1-12

  4. Percentage of Participants With a Migraine on the Day After Dosing

    The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing

    Time frame: 1 day

  5. 75% Headache Responder Rate

    Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.

    Time frame: Week 1-12

  6. 50% Headache Responder Rate

    Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.

    Time frame: Week 1-12

  7. 100% Migraine Responder Rate

    Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline

    Time frame: Week 1-12

  8. 100% Headache Responder Rate

    Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.

    Time frame: Week 1-12

  9. Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)

    The change in number of days with any triptan or ergotamine use as recorded in the eDiary.

    Time frame: Week 1-12

  10. Change From Baseline in Average Daily Migraine Prevalence to Week 4

    The change in the percentage of days where a participant has a migraine from baseline to Week 4.

    Time frame: Baseline to Week 4

  11. Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication

    The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.

    Time frame: Week 1-12

  12. Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication

    The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.

    Time frame: Week 1-12

  13. Change From Baseline in Monthly Headache Days (Weeks 1-12)

    Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.

    Time frame: Week 1-12

  14. Percent of Headaches With Severe Intensity

    Summary of percent of headaches with severe intensity over Weeks 1-12.

    Time frame: Week 1-12

  15. Percent of Migraines With Severe Intensity

    Summary of percent of migraines with severe intensity over Week 1-12.

    Time frame: Week 1-12

  16. Change From Baseline in Monthly Migraine Hours (Weeks 1-12)

    Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.

    Time frame: Week 1-12

  17. Change From Baseline in Monthly Headache Hours, Weeks 1-12

    Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.

    Time frame: Week 1-12

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

    The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.

    Time frame: Baseline to Week 12

  19. Health Related Quality of Life (EQ-5D-5L) at Week 12

    The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/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.

    Time frame: Week 12

  20. Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score

    The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.

    Time frame: Baseline to Week 12

07

Results

Posted May 14, 2020

Participant flow

Participant flow — Overall Study
Milestone300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Started224225224225
Participants treated222221223222
Completed169172170165
Not completed55535460
Withdrew: Adverse event3321
Withdrew: Lack of efficacy2328
Withdrew: Lost to follow-up22161217
Withdrew: Physician decision1130
Withdrew: Withdrawal by subject169209
Withdrew: Study burden10161222
Withdrew: Other1533

Outcome measures

PrimaryChange From Baseline in Monthly Migraine Days (Weeks 1-12)

Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

Time frame:
Week 1-12
Reported as:
Mean · Migraine Days
Change From Baseline in Monthly Migraine Days (Weeks 1-12)
Migraine Days300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Monthly Migraine Days (Weeks 1-12)-4.3 ± 3.42-3.9 ± 3.23-4.1 ± 3.22-3.1 ± 3.70
Statistical analysis
  • 300 mg ALD403 vs Placebo · ANCOVA · p = 0.0001 · Mean difference (final values): -1.11 · 95% CI -1.68 to -0.54
  • 100 mg ALD403 vs Placebo · ANCOVA · p = 0.0182 · Mean difference (final values): -0.69 · 95% CI -1.25 to -0.12
  • 30 mg ALD403 vs Placebo · ANCOVA · p = 0.0046 · Mean difference (final values): -0.82 · 95% CI -1.39 to -0.25
Secondary75% Migraine Responder Rate

Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
75% Migraine Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
75% Migraine Responder Rate66495536
Statistical analysis
  • 300 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0007 · Mean difference (final values): 13.5 · 95% CI 5.8 to 21.2
  • 100 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.1126 · Mean difference (final values): 6.0 · 95% CI -1.4 to 13.3
  • 30 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0272 · Mean difference (final values): 8.4 · 95% CI 1.0 to 15.9
Secondary75% Migraine Responder Rate

Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.

Time frame:
Week 1-4
Reported as:
Count of participants · Participants
75% Migraine Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
75% Migraine Responder Rate70686745
Statistical analysis
  • 300 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0066 · Mean difference (final values): 11.3 · 95% CI 3.2 to 19.3
  • 100 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0112 · Mean difference (final values): 10.5 · 95% CI 2.4 to 18.6
  • 30 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0170 · Mean difference (final values): 9.8 · 95% CI 1.8 to 17.8
Secondary50% Migraine Responder Rate

Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
50% Migraine Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
50% Migraine Responder Rate12511011283
Statistical analysis
  • 300 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001 · Mean difference (final values): 18.9 · 95% CI 9.8 to 28.0
  • 100 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0085 · Mean difference (final values): 12.4 · 95% CI 3.2 to 21.5
  • 30 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0064 · Mean difference (final values): 12.8 · 95% CI 3.7 to 22.0
SecondaryPercentage of Participants With a Migraine on the Day After Dosing

The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing

Time frame:
1 day
Reported as:
Number · Percentage of participants
Percentage of Participants With a Migraine on the Day After Dosing
Percentage of participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Percentage of Participants With a Migraine on the Day After Dosing13.914.817.322.5
Statistical analysis
  • 300 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0159
  • 100 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.0312
  • 30 mg ALD403 vs Placebo · Cochran-Mantel-Haenszel · p = 0.1539
Secondary75% Headache Responder Rate

Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
75% Headache Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
75% Headache Responder Rate42283423
Secondary50% Headache Responder Rate

Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
50% Headache Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
50% Headache Responder Rate113989874
Secondary100% Migraine Responder Rate

Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
100% Migraine Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
100% Migraine Responder Rate9144
Secondary100% Headache Responder Rate

Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.

Time frame:
Week 1-12
Reported as:
Count of participants · Participants
100% Headache Responder Rate
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
100% Headache Responder Rate6042
SecondaryChange From Baseline in Acute Migraine Medication Days (Weeks 1-12)

The change in number of days with any triptan or ergotamine use as recorded in the eDiary.

Time frame:
Week 1-12
Reported as:
Mean · days
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
days300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)-0.8 ± 1.77-0.9 ± 2.00-0.6 ± 1.62-0.4 ± 1.27
SecondaryChange From Baseline in Average Daily Migraine Prevalence to Week 4

The change in the percentage of days where a participant has a migraine from baseline to Week 4.

Time frame:
Baseline to Week 4
Reported as:
Mean · percentage of days with migraine
Change From Baseline in Average Daily Migraine Prevalence to Week 4
percentage of days with migraine300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Average Daily Migraine Prevalence to Week 4-14.9 ± 19.78-13.8 ± 19.27-15.1 ± 17.83-9.7 ± 19.33
SecondaryChange From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication

The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.

Time frame:
Week 1-12
Reported as:
Mean · percentage of acute medication migraines
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
percentage of acute medication migraines300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication62.08 ± 38.4666.58 ± 34.1369.11 ± 33.7271.44 ± 34.59
SecondaryChange From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication

The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.

Time frame:
Week 1-12
Reported as:
Mean · percentage of acute medication headaches
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
percentage of acute medication headaches300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication63.09 ± 36.8766.85 ± 33.6567.84 ± 33.5970.95 ± 33.43
SecondaryChange From Baseline in Monthly Headache Days (Weeks 1-12)

Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.

Time frame:
Week 1-12
Reported as:
Mean · headache days
Change From Baseline in Monthly Headache Days (Weeks 1-12)
headache days300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Monthly Headache Days (Weeks 1-12)-4.5 ± 3.96-4.0 ± 3.30-4.4 ± 3.24-3.3 ± 3.51
SecondaryPercent of Headaches With Severe Intensity

Summary of percent of headaches with severe intensity over Weeks 1-12.

Time frame:
Week 1-12
Reported as:
Mean · percentage of severe intensity headaches
Percent of Headaches With Severe Intensity
percentage of severe intensity headaches300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Percent of Headaches With Severe Intensity17.06 ± 22.0319.84 ± 24.8321.20 ± 26.6021.68 ± 22.67
SecondaryPercent of Migraines With Severe Intensity

Summary of percent of migraines with severe intensity over Week 1-12.

Time frame:
Week 1-12
Reported as:
Mean · percentage of severe intensity migraines
Percent of Migraines With Severe Intensity
percentage of severe intensity migraines300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Percent of Migraines With Severe Intensity19.07 ± 23.4622.23 ± 26.3024.43 ± 28.1526.01 ± 24.99
SecondaryChange From Baseline in Monthly Migraine Hours (Weeks 1-12)

Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.

Time frame:
Week 1-12
Reported as:
Mean · migraine hours
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
migraine hours300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)-42.9 ± 49.91-35.3 ± 47.85-37.8 ± 50.17-23.8 ± 50.91
SecondaryChange From Baseline in Monthly Headache Hours, Weeks 1-12

Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.

Time frame:
Week 1-12
Reported as:
Mean · headache hours
Change From Baseline in Monthly Headache Hours, Weeks 1-12
headache hours300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change From Baseline in Monthly Headache Hours, Weeks 1-12-42.0 ± 56.67-34.2 ± 49.19-38.8 ± 50.45-24.5 ± 48.15
SecondaryChange From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores

The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.

Time frame:
Baseline to Week 12
Reported as:
Mean · score on a scale
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
score on a scale300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Physical Functioning0.9 ± 5.781.2 ± 6.880.9 ± 6.740.3 ± 6.43
Role Physical3.0 ± 6.542.3 ± 7.652.4 ± 7.722.2 ± 6.78
Bodily Pain4.5 ± 8.274.3 ± 8.373.5 ± 9.122.3 ± 8.70
General Health1.2 ± 6.780.7 ± 7.220.6 ± 7.540.0 ± 6.52
Vitality2.3 ± 7.911.8 ± 8.360.2 ± 8.611.7 ± 7.43
SecondaryHealth Related Quality of Life (EQ-5D-5L) at Week 12

The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/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.

Time frame:
Week 12
Reported as:
Count of participants · Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12
Participants300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Mobility — No problems183181181179
Mobility — Slight problems21181615
Mobility — Moderate problems4634
Mobility — Severe problems0110
Mobility — Extreme problems0000
Self-care — No problems206201198195
Self-care — Slight problems2433
Self-care — Moderate problems0100
Self-care — Severe problems0000
Self-care — Extreme problems0000
Usual Activities — No problems177173176172
Usual Activities — Slight problems29222119
Usual Activities — Moderate problems21037
Usual Activities — Severe problems0010
Usual Activities — Extreme problems0100
Pain/Discomfort — No problems113116123110
Pain/Discomfort — Slight problems75655768
Pain/Discomfort — Moderate problems19241818
Pain/Discomfort — Severe problems1132
Pain/Discomfort — Extreme problems0000
Anxiety/Depression — No problems158156168151
Anxiety/Depression — Slight problems46382438
Anxiety/Depression — Moderate problems3988
Anxiety/Depression — Severe problems1200
Anxiety/Depression — Extreme problems0111
SecondaryChange in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score

The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.

Time frame:
Baseline to Week 12
Reported as:
Mean · score on a scale
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
score on a scale300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score-1.6 ± 4.22-1.8 ± 3.90-1.6 ± 3.95-1.7 ± 4.33

Adverse events

Collected over Baseline to Week 56 (end of study). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
300 mg ALD4030/224 (0%)3/224 (1.3%)44/224 (19.6%)
100 mg ALD4030/223 (0%)4/223 (1.8%)44/223 (19.7%)
30 mg ALD4030/219 (0%)4/219 (1.8%)44/219 (20.1%)
Placebo0/222 (0%)6/222 (2.7%)41/222 (18.5%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
Event300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Hepatic CholestaticHepatobiliary disorders0/2240/2231/2190/222
Stomal HerniaInjury, poisoning and procedural complications0/2240/2231/2190/222
RhabdomyolysisMusculoskeletal and connective tissue disorders0/2240/2231/2190/222
Acute Kidney InjuryRenal and urinary disorders0/2240/2231/2190/222
NephrolithiasisRenal and urinary disorders0/2240/2231/2190/222
CellulitisInfections and infestations0/2240/2230/2191/222
Intervertebral Disc ProtrusionMusculoskeletal and connective tissue disorders0/2240/2230/2191/222
Breast Cancer Stage IINeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2240/2230/2191/222
MigraineNervous system disorders0/2240/2230/2191/222
SyncopeNervous system disorders0/2240/2230/2191/222
Most frequent other events
Most frequent other events
Event300 mg ALD403100 mg ALD40330 mg ALD403Placebo
Upper respiratory tract infectionInfections and infestations23/22422/22325/21916/222
NasopharyngitisInfections and infestations14/22417/22314/21912/222
SinusitisInfections and infestations11/2246/2237/21914/222

Baseline characteristics

Safety population includes all participants who received study drug or placebo. 2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.

Age, Continuous
Age, Continuous(years)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
Mean40.2 ± 11.7240.0 ± 10.6639.1 ± 11.5439.9 ± 11.6739.8 ± 11.39
Sex: Female, Male
Sex: Female, Male(Participants)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
Female199179185186749
Male25443436139
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
Hispanic or Latino40424534161
Not Hispanic or Latino184181174188727
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
American Indian or Alaska Native20013
Asian11125
Native Hawaiian or Other Pacific Islander11013
Black or African American27173130105
White187196180181744
More than one race575522
Unknown or Not Reported11226
Region of Enrollment
Region of Enrollment(Participants)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
United States185184194185748
Georgia39392537140
Number of migraine days
Number of migraine days(Days)300 mg ALD403100 mg ALD40330 mg ALD403PlaceboTotal
Mean7.8 ± 2.597.5 ± 2.607.9 ± 2.707.5 ± 2.427.7 ± 2.58
08

Study locations

87 sites
  • Research Site
    Birmingham, Alabama 35216, United States
  • Research Site
    Phoenix, Arizona 85013, United States
  • Research Site
    Tucson, Arizona 85712, United States
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Anaheim, California 92801, United States
  • Research Site
    Fresno, California 93702, United States
  • Research Site
    Fullerton, California 92835, United States
  • Research Site
    Long Beach, California 90806, United States
  • Research Site
    Montclair, California 91763, United States
  • Research Site
    Oceanside, California 92056, United States
  • Research Site
    Redlands, California 92374, United States
  • Research Site
    San Diego, California 92103, United States
  • Research Site
    San Diego, California 92108, United States
  • Research Site
    Santa Monica, California 90404, United States
  • Research Site
    Sherman Oaks, California 91403, United States
  • Research Site
    Colorado Springs, Colorado 80918, United States
  • Research Site
    Fort Collins, Colorado 80528, United States
  • Research Site
    Stamford, Connecticut 06905, United States
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    Waterbury, Connecticut 06708, United States
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    Bradenton, Florida 34201, United States
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    DeLand, Florida 32720, United States
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    Miami, Florida 33173, United States
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    Naples, Florida 34102, United States
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    Orlando, Florida 32801, United States
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    Sunrise, Florida 33351, United States
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    Winter Haven, Florida 33880, United States
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    Atlanta, Georgia 30331, United States
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    Atlanta, Georgia 30342, United States
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    Stockbridge, Georgia 30281, United States
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    Chicago, Illinois 60607, United States
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    Boston, Massachusetts 02131, United States
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    North Attleboro, Massachusetts 02760, United States
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    Watertown, Massachusetts 02472, United States
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    Ann Arbor, Michigan 48104, United States
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    Farmington Hills, Michigan 48334, United States
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    Jackson, Michigan 49201, United States
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    Minneapolis, Minnesota 55402, United States
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    Flowood, Mississippi 39232, United States
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    Saint Louis, Missouri 63141, United States
  • Research Site
    Springfield, Missouri 65807, United States
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    Las Vegas, Nevada 89119, United States
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    Reno, Nevada 89502, United States
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    Albuquerque, New Mexico 87102, United States
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    Brooklyn, New York 11213, United States
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    Brooklyn, New York 11229, United States
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    Hartsdale, New York 10530, United States
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    Rochester, New York 14609, United States
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    Staten Island, New York 10312, United States
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    Durham, North Carolina 27713, United States
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    Greensboro, North Carolina 27405, United States
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    High Point, North Carolina 27265, United States
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    Wilmington, North Carolina 28401, United States
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    Dayton, Ohio 45424, United States
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    Edmond, Oklahoma 73034, United States
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    Norman, Oklahoma 73069, United States
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    Oklahoma City, Oklahoma 73112, United States
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    Portland, Oregon 97210, United States
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    Allentown, Pennsylvania 18104, United States
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    Smithfield, Pennsylvania 15478, United States
  • Research Site
    Anderson, South Carolina 29621, United States
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    Chattanooga, Tennessee 37404, United States
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    Chattanooga, Tennessee 37421, United States
  • Research Site
    Kingsport, Tennessee 37660, United States
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    Memphis, Tennessee 38119, United States
  • Research Site
    Austin, Texas 78745, United States
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    Dallas, Texas 75231, United States
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    Houston, Texas 77074, United States
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    Houston, Texas 77081, United States
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    Richmond, Virginia 23294, United States
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    Virginia Beach, Virginia 23454, United States
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    Bellevue, Washington 98007, United States
  • Research Site
    Tbilisi, 0112, Georgia
  • Research Site
    Tbilisi, 0160, Georgia
  • Research Site
    Tbilisi, 0179, Georgia
  • Research Site
    Tbilisi, 0186, Georgia
09

References and documents

Publications

  • Pozo-Rosich P, Dodick DW, Ettrup A, Hirman J, Cady R. Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies. BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9. PubMed 36284281 ↗
  • Apelian R, Boyle L, Hirman J, Asher D. Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2. J Headache Pain. 2022 Apr 18;23(1):48. doi: 10.1186/s10194-022-01418-8. PubMed 35436857 ↗
  • Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18. PubMed 35302389 ↗
  • Martin V, Nagy AJ, Janelidze M, Giorgadze G, Hirman J, Cady R, Mehta L, Buse DC. Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2. Clin Ther. 2022 Mar;44(3):389-402. doi: 10.1016/j.clinthera.2022.01.006. Epub 2022 Feb 5. PubMed 35131090 ↗
  • Lipton RB, Charleston L 4th, Tassorelli C, Brevig T, Hirman J, Cady R. Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a >/= 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials. J Headache Pain. 2022 Feb 7;23(1):23. doi: 10.1186/s10194-022-01386-z. PubMed 35130836 ↗
  • Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1. PubMed 34823467 ↗
  • 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. Erratum In: J Headache Pain. 2021 May 25;22(1):46. doi: 10.1186/s10194-021-01253-3. PubMed 33781209 ↗
  • Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B. Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. 2020 Dec;42(12):2254-2265.e3. doi: 10.1016/j.clinthera.2020.11.007. Epub 2020 Nov 27. Erratum In: Clin Ther. 2021 Apr;43(4):791. doi: 10.1016/j.clinthera.2021.01.019. PubMed 33250209 ↗
  • Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19. PubMed 32075406 ↗

Study documents

  • Study protocol · Apr 24, 2017
  • Statistical analysis plan · May 18, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02559895
Lead sponsor
Alder Biopharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Sep 25, 2015
Start date
Sep 2015
Primary completion
Feb 2017
Completion
Dec 2017
Results posted
May 14, 2020
Last update
May 14, 2020

Study contacts

Tim Whitaker, MD
study director · Alder Biopharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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