Migraine DisordersPhase 3PROMISE 1NCT02559895

A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

A Phase 3 study testing ALD403 in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 87 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Migraine Disorders
What is being tested?: ALD403
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 898 participants
Where: 87 sitesin 2 countries
Study dates: Sep 2015to Dec 2017
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

87 sites in 2 countries.

Country

City, postcode or hospital

87 sites in 2 countries

United States83 sites

Research Site
Albuquerque, New Mexico, 87102
Research Site
Allentown, Pennsylvania, 18104
Research Site
Anaheim, California, 92801
Research Site
Anderson, South Carolina, 29621
Research Site
Ann Arbor, Michigan, 48104
Research Site
Atlanta, Georgia, 30331
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78745
Research Site
Bellevue, Washington, 98007
Research Site
Birmingham, Alabama, 35216
Research Site
Boston, Massachusetts, 02131
Research Site
Bradenton, Florida, 34201
Research Site
Brooklyn, New York, 11213
Research Site
Brooklyn, New York, 11229
Research Site
Chattanooga, Tennessee, 37404
Research Site
Chattanooga, Tennessee, 37421
Research Site
Chicago, Illinois, 60607
Research Site
Colorado Springs, Colorado, 80918
Research Site
Dallas, Texas, 75231
Research Site
Dayton, Ohio, 45424
Research Site
DeLand, Florida, 32720
Research Site
Durham, North Carolina, 27713
Research Site
Edmond, Oklahoma, 73034
Research Site
Farmington Hills, Michigan, 48334
Research Site
Flowood, Mississippi, 39232
Research Site
Fort Collins, Colorado, 80528
Research site
Fort Myers, Florida, 33912
Research Site
Fresno, California, 93702
Research Site
Fullerton, California, 92835
Research Site
Greensboro, North Carolina, 27405
Research Site
Hallandale, Florida, 33009
Research Site
Hartsdale, New York, 10530
Research Site
Hialeah, Florida, 33012
Research Site
High Point, North Carolina, 27265
Research Site
Houston, Texas, 77074
Research Site
Houston, Texas, 77081
Research Site
Jackson, Michigan, 49201
Research Site
Kingsport, Tennessee, 37660
Research Site
Las Vegas, Nevada, 89119
Research Site
Lexington, Kentucky, 40509
Research Site
Lisle, Illinois, 60532
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90806
Research Site
Maitland, Florida, 32751
Research Site
Memphis, Tennessee, 38119
Research Site
Miami, Florida, 33143
Research Site
Miami, Florida, 33155
Research Site
Miami, Florida, 33173
Research Site
Minneapolis, Minnesota, 55402
Research Site
Montclair, California, 91763
Research Site
Naples, Florida, 34102
Research Site
New Orleans, Louisiana, 70115
Research Site
Norman, Oklahoma, 73069
Research Site
North Attleboro, Massachusetts, 02760
Research Site
Oceanside, California, 92056
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Orlando, Florida, 32801
Research Site
Owensboro, Kentucky, 42303
Research Site
Phoenix, Arizona, 85013
Research Site
Portland, Oregon, 97210
Research Site
Prairie Village, Kansas, 66206
Research Site
Redlands, California, 92374
Research Site
Reno, Nevada, 89502
Research Site
Richmond, Virginia, 23294
Research Site
Rochester, New York, 14609
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92108
Research Site
Santa Monica, California, 90404
Research Site
Sherman Oaks, California, 91403
Research Site
Smithfield, Pennsylvania, 15478
Research Site
Springfield, Massachusetts, 01104
Research Site
Springfield, Missouri, 65807
Research Site
St Louis, Missouri, 63141
Research Site
Stamford, Connecticut, 06905
Research Site
Staten Island, New York, 10312
Research Site
Stockbridge, Georgia, 30281
Research Site
Sunrise, Florida, 33351
Research Site
Tucson, Arizona, 85712
Research Site
Virginia Beach, Virginia, 23454
Research Site
Waterbury, Connecticut, 06708
Research Site
Watertown, Massachusetts, 02472
Research Site
Wilmington, North Carolina, 28401
Research Site
Winter Haven, Florida, 33880

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Georgia4 sites

Research Site
Tbilisi, 0112
Research Site
Tbilisi, 0160
Research Site
Tbilisi, 0179
Research Site
Tbilisi, 0186

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About this study

Official title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

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

Conditions: Migraine Disorders
Being tested: ALD403, Placebo
Medical subject headings: Migraine Disorders

What participants receive

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

ALD403Drug
Also called Eptinezumab-jjmr, Vyepti
PlaceboDrug

Study groups in NCT02559895
Study group	Role	What they receive
ALD403 Dose Level 1	Experimental	ALD403 Dose Level 1 (IV) Receives: Drug: ALD403
ALD403 Dose Level 2	Experimental	ALD403 Dose Level 2 (IV) Receives: Drug: ALD403
ALD403 Dose Level 3	Experimental	ALD403 Dose Level 3 (IV) Receives: Drug: ALD403
Placebo	Placebo comparator	Placebo (IV) Receives: Drug: Placebo

What is being measured

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

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
Measured: Week 1-12

Secondary outcomes (20)

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.
Measured: Week 1-12
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.
Measured: Week 1-4
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
Measured: Week 1-12
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
Measured: 1 day
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.
Measured: Week 1-12
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.
Measured: Week 1-12
100% Migraine Responder Rate
Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline
Measured: Week 1-12
100% Headache Responder Rate
Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.
Measured: Week 1-12
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.
Measured: Week 1-12
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.
Measured: Baseline to Week 4
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.
Measured: Week 1-12
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.
Measured: Week 1-12
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.
Measured: Week 1-12
Percent of Headaches With Severe Intensity
Summary of percent of headaches with severe intensity over Weeks 1-12.
Measured: Week 1-12
Percent of Migraines With Severe Intensity
Summary of percent of migraines with severe intensity over Week 1-12.
Measured: Week 1-12
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.
Measured: Week 1-12
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.
Measured: Week 1-12
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.
Measured: Baseline to Week 12
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.
Measured: Week 12
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.
Measured: Baseline to Week 12

Timeline

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

Sep 2015Dec 2017

First posted25 Sep 2015 (estimated)
Study startSep 2015
Primary completionFeb 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Migraine DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 898 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02559895
Sponsor's protocol ID: ALD403-CLIN-006
Acronym: PROMISE 1
Status last verified: May 2020
First submitted: 22 Sep 2015
Last updated: 14 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
ClinicalTrials.gov ID: NCT02559895
Acronym / sponsor ID: PROMISE 1 / ALD403-CLIN-006
Conditions: Migraine Disorders
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 898 participants (actual)
Lead sponsor: Alder Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Feb 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 25 Sep 2015 (estimated)
Results: Posted 14 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
ALD403 Dose Level 1	Experimental	Drug: ALD403ALD403 Dose Level 1 (IV)
ALD403 Dose Level 2	Experimental	Drug: ALD403ALD403 Dose Level 2 (IV)
ALD403 Dose Level 3	Experimental	Drug: ALD403ALD403 Dose Level 3 (IV)
Placebo	Placebo comparator	Drug: PlaceboPlacebo (IV)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
History of migraine ≥ 12 months with
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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALD403Also: Eptinezumab-jjmr, Vyepti	Drug	ALD403 Dose Level 1, ALD403 Dose Level 2, ALD403 Dose Level 3
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Monthly Migraine Days (Weeks 1-12)
Time frame: Week 1-12
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

20 secondary outcomes

75% Migraine Responder Rate
Time frame: Week 1-12
75% Migraine Responder Rate
Time frame: Week 1-4
50% Migraine Responder Rate
Time frame: Week 1-12
Percentage of Participants With a Migraine on the Day After Dosing
Time frame: 1 day
75% Headache Responder Rate
Time frame: Week 1-12
50% Headache Responder Rate
Time frame: Week 1-12
100% Migraine Responder Rate
Time frame: Week 1-12
100% Headache Responder Rate
Time frame: Week 1-12
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
Time frame: Week 1-12
Change From Baseline in Average Daily Migraine Prevalence to Week 4
Time frame: Baseline to Week 4
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
Time frame: Week 1-12
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
Time frame: Week 1-12
Change From Baseline in Monthly Headache Days (Weeks 1-12)
Time frame: Week 1-12
Percent of Headaches With Severe Intensity
Time frame: Week 1-12
Percent of Migraines With Severe Intensity
Time frame: Week 1-12
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
Time frame: Week 1-12
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Time frame: Week 1-12
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Time frame: Baseline to Week 12
Health Related Quality of Life (EQ-5D-5L) at Week 12
Time frame: Week 12
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 14 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
300 mg ALD403	224	169
100 mg ALD403	225	172
30 mg ALD403	224	170
Placebo	225	165

Primary outcome: Change From Baseline in Monthly Migraine Days (Weeks 1-12)

Time frame: Week 1-12. Mean (Standard Deviation). Unit: Migraine Days

Measure	300 mg ALD403 n = 222	100 mg ALD403 n = 221	30 mg ALD403 n = 223	Placebo n = 222
Value	-4.3 (3.42)	-3.9 (3.23)	-4.1 (3.22)	-3.1 (3.70)

300 mg ALD403 vs Placebo: Mean Difference (Final Values): -1.11 (95% CI -1.68 to -0.54), p = 0.0001, ANCOVA
100 mg ALD403 vs Placebo: Mean Difference (Final Values): -0.69 (95% CI -1.25 to -0.12), p = 0.0182, ANCOVA
30 mg ALD403 vs Placebo: Mean Difference (Final Values): -0.82 (95% CI -1.39 to -0.25), p = 0.0046, ANCOVA

Population analysed: Full Analysis Population - all randomized participants who received investigational product or placebo

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 56 (end of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
300 mg ALD403	3 of 224 (1.3%)	44 of 224 (19.6%)	0 of 224
100 mg ALD403	4 of 223 (1.8%)	44 of 223 (19.7%)	0 of 223
30 mg ALD403	4 of 219 (1.8%)	44 of 219 (20.1%)	0 of 219
Placebo	6 of 222 (2.7%)	41 of 222 (18.5%)	0 of 222

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36284281Pozo-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.
Derived from this study: PubMed 35436857Apelian 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.
Derived from this study: PubMed 35302389Ashina 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.
Derived from this study: PubMed 35131090Martin 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.
Derived from this study: PubMed 35130836Lipton 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.
Derived from this study: PubMed 34823467Smith 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.
Derived from this study: PubMed 33781209Smith 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.
Derived from this study: PubMed 33250209Smith 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.
Derived from this study: PubMed 32075406Ashina 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.

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Study of the Glymphatic System in Migraine
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Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tim Whitaker, MD study director

Alder Biopharmaceuticals, Inc.

87 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALD403 in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 87 sites in 2 countries.

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 6 inclusion and 7 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Georgia. 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. Some participants in this study may receive a placebo. 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 14 May 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?

Change From Baseline in Monthly Migraine Days (Weeks 1-12) (time frame: Week 1-12). 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 NCT02559895, which also lists 9 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 14 May 2020.