Migraine DisordersPhase 2NCT02275117

A Multicenter Assessment of ALD403 in Chronic Migraine

A Phase 2 study testing ALD403 in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 92 sites in 4 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 chronic migraineurs. Read more about this study

Who is it for?: Ages 18 to 55 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: 665 participants
Where: 92 sitesin 4 countries
Study dates: Oct 2014to Nov 2016
Phase: Phase 2
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Who cannot join

Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, 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-III beta version, 2013), 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
Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
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

92 sites in 4 countries.

Country

City, postcode or hospital

92 sites in 4 countries

United States82 sites

Research Site
Albany, New York, 12208
Research Site
Albuquerque, New Mexico, 87102
Research Site
Amherst, New York, 14226
Research Site
Anaheim, California, 92801
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Ann Arbor, Michigan, 48104
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Atlanta, Georgia, 30022
Research Site
Atlanta, Georgia, 30342
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Austin, Texas, 78705
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Bellevue, Washington, 98007
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Boston, Massachusetts, 21310
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Brockton, Massachusetts, 02301
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Brooklyn, New York, 11235
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Canton, Ohio, 44718
Research Site
Cary, North Carolina, 27518
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Chattanooga, Tennessee, 37421
Research Site
Chicago, Illinois, 60607
Research Site
Chicago, Illinois, 60640
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Cincinnati, Ohio, 45255
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Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80918
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Columbus, Ohio, 43213
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Dallas, Texas, 75231
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Dayton, Ohio, 45424
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Denver, Colorado, 80210
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Encino, California, 91436
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Endwell, New York, 13760
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Evansville, Illinois, 47714
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Fort Worth, Texas, 76104
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Gainesville, Florida, 32607
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Hallandale, Florida, 33009
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Hot Springs, Arkansas, 71901
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Houston, Texas, 77058
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Huntsville, Alabama, 35801
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Jacksonville, Florida, 32256
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Little Rock, Arkansas, 72211
Reserach Site
Long Beach, California, 90806
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Los Angeles, California, 90036
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Louisville, Kentucky, 40207
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Memphis, Tennessee, 38119
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Miami, Florida, 33144
Research Site
Miami, Florida, 33173
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Mobile, Alabama, 36608
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Mt. Pleasant, South Carolina, 29464
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New Bedford, Massachusetts, 02740
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New Orleans, Louisiana, 70115
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New York, New York, 10019
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Normal, Illinois, 61761
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North Miami, Florida, 33161
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Oakland, California, 94612
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Oklahoma City, Oklahoma, 73116
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Omaha, Nebraska, 68134
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Orem, Utah, 84058
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Orlando, Florida, 32801
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85027
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Portland, Oregon, 97239
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Prairie Village, Kansas, 66206
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Princeton, New Jersey, 08540
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Richmond, Virginia, 23226
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Rochester, New York, 14609
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Salt Lake City, Utah, 84109
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San Diego, California, 92108
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San Francisco, California, 94102
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Santa Monica, California, 90404
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Scottsdale, Arizona, 85259
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Seattle, Washington, 98105
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Shreveport, Louisiana, 71105
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Springfield, Missouri, 65807
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St Louis, Missouri, 63141
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Stamford, Connecticut, 06905
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Stanford, California, 94305
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Tacoma, Washington, 98405
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Tampa, Florida, 33606
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The Bronx, New York, 10461
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Ventura, California, 93003
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Virginia Beach, Virginia, 23454
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Waterbury, Connecticut, 06708
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Watertown, Massachusetts, 02472
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Wichita, Kansas, 67207
Research Site
Willow Grove, Pennsylvania, 19090
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Australia4 sites

Research Site
Melbourne, Victoria, 3004
Research Site
Melbourne, Victoria, 3050
Research Site
Perth, Western Australia, 6009
Research Site
Sydney, New South Wales, 2031

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Georgia3 sites

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

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New Zealand3 sites

Research Site
Auckland, 8963
Research Site
Christchurch, 2856
Research Site
Hamilton, 3204

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About this study

Official title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

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

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

What participants receive

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

ALD403Biological
Also called Eptinezumab-jjmr, Vyepti
PlaceboBiological

Study groups in NCT02275117
Study group	Role	What they receive
ALD403 Dose Level 1	Experimental	ALD403 Dose Level 1 (IV) Receives: Biological: ALD403
ALD403 Dose Level 2	Experimental	ALD403 Dose Level 2 (IV) Receives: Biological: ALD403
ALD403 Dose Level 3	Experimental	ALD403 Dose Level 3 (IV) Receives: Biological: ALD403
ALD403 Dose Level 4	Experimental	ALD403 Dose Level 4 (IV) Receives: Biological: ALD403
Placebo	Placebo comparator	Placebo (IV) Receives: Biological: Placebo

What is being measured

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

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: 12 Weeks

Secondary outcomes (19)

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: Weeks 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: Weeks 1-12
100% Headache Responder Rate
Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
Measured: Weeks 1-12
100% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
Measured: Weeks 1-12
The Change From Baseline in Monthly Headache Days, Weeks 1-12
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Measured: Weeks 1-12
The Change From Baseline in Monthly Migraine Days, Weeks 1-12
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Measured: Weeks 1-12
Change From Baseline in Percentage of Severe Migraines
The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
Measured: Weeks 1-12
Change From Baseline in Percentage of Severe Headaches
The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
Measured: Weeks 9-12
The Change From Baseline to Week 12 in HIT-6 Total 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 assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). A score of 60 or above is labeled as "severe".
Measured: Baseline to 12
Percent Change From Baseline in Headache Days
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Measured: Weeks 1-12
Percent Change From Baseline in Migraine Days
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Measured: Weeks 1-12
Time to First Migraine After Dosing
The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
Measured: Baseline to Week 49 (End of Study)
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days
Measured: Weeks 1-12
Change From Baseline in Monthly Headache Episodes, Weeks 1-12
The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days
Measured: Weeks 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: Weeks 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: Weeks 1-12
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Measured: Weeks 9-12
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Measured: Weeks 9-12
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
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 (range: 0=worst to 100=best). Increases from baseline indicate improvement.
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.

Oct 2014Nov 2016

First posted27 Oct 2014 (estimated)
Study startOct 2014
Primary completionMar 2016
Study completionNov 2016

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 (3)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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 665 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02275117
Sponsor's protocol ID: ALD403-CLIN-005
Status last verified: Mar 2020
First submitted: 20 Oct 2014
Last updated: 8 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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
Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
PubMed 31234642

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?

See locations

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Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
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All Migraine Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine
ClinicalTrials.gov ID: NCT02275117
Acronym / sponsor ID: ALD403-CLIN-005
Conditions: Migraine Disorders
Keywords: Migraine Disorders, ALD403
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 665 participants (actual)
Lead sponsor: Alder Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Mar 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 27 Oct 2014 (estimated)
Results: Posted 30 Mar 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 chronic migraineurs.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
ALD403 Dose Level 1	Experimental	Biological: ALD403ALD403 Dose Level 1 (IV)
ALD403 Dose Level 2	Experimental	Biological: ALD403ALD403 Dose Level 2 (IV)
ALD403 Dose Level 3	Experimental	Biological: ALD403ALD403 Dose Level 3 (IV)
ALD403 Dose Level 4	Experimental	Biological: ALD403ALD403 Dose Level 4 (IV)
Placebo	Placebo comparator	Biological: PlaceboPlacebo (IV)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Key exclusion criteria (8 listed)

Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, 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-III beta version, 2013), 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
Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.

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	Biological	ALD403 Dose Level 1, ALD403 Dose Level 2, ALD403 Dose Level 3, ALD403 Dose Level 4
Placebo	Biological	Placebo

Primary outcome

75% Migraine Responder Rate
Time frame: 12 Weeks
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.

19 secondary outcomes

50% Migraine Responder Rate
Time frame: Weeks 1-12
50% Headache Responder Rate
Time frame: Weeks 1-12
100% Headache Responder Rate
Time frame: Weeks 1-12
100% Migraine Responder Rate
Time frame: Weeks 1-12
The Change From Baseline in Monthly Headache Days, Weeks 1-12
Time frame: Weeks 1-12
The Change From Baseline in Monthly Migraine Days, Weeks 1-12
Time frame: Weeks 1-12
Change From Baseline in Percentage of Severe Migraines
Time frame: Weeks 1-12
Change From Baseline in Percentage of Severe Headaches
Time frame: Weeks 9-12
The Change From Baseline to Week 12 in HIT-6 Total Score
Time frame: Baseline to 12
Percent Change From Baseline in Headache Days
Time frame: Weeks 1-12
Percent Change From Baseline in Migraine Days
Time frame: Weeks 1-12
Time to First Migraine After Dosing
Time frame: Baseline to Week 49 (End of Study)
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
Time frame: Weeks 1-12
Change From Baseline in Monthly Headache Episodes, Weeks 1-12
Time frame: Weeks 1-12
Change From Baseline in Monthly Migraine Hours, Weeks 1-12
Time frame: Weeks 1-12
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Time frame: Weeks 1-12
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
Time frame: Weeks 9-12
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
Time frame: Weeks 9-12
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 30 Mar 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	131	97
100 mg ALD403	133	96
30 mg ALD403	134	92
10 mg ALD403	133	100
Placebo	134	98

Primary outcome: 75% Migraine Responder Rate

Time frame: 12 Weeks. Count of participants. Unit: Participants

Measure	300 mg ALD403 n = 114	100 mg ALD403 n = 118	30 mg ALD403 n = 117	10 mg ALD403 n = 123	Placebo n = 116
Value	38	37	33	33	24

300 mg ALD403 vs Placebo: Mean Difference (Final Values): 12.6 (95% CI 1.3 to 24.0), p = 0.0330, Cochran-Mantel-Haenszel
100 mg ALD403 vs Placebo: Mean Difference (Final Values): 10.7 (95% CI -0.5 to 21.8), p = 0.0715, Cochran-Mantel-Haenszel
30 mg ALD403 vs Placebo: Mean Difference (Final Values): 7.5 (95% CI -3.5 to 18.5), p = 0.2013, Cochran-Mantel-Haenszel

Population analysed: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 49 (end of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
300 mg ALD403	7 of 121 (5.8%)	40 of 121 (33.1%)	0 of 121
100 mg ALD403	4 of 122 (3.3%)	38 of 122 (31.1%)	0 of 122
30 mg ALD403	0 of 122 (0%)	26 of 122 (21.3%)	0 of 122
10 mg ALD403	1 of 130 (0.8%)	35 of 130 (26.9%)	0 of 130
Placebo	1 of 121 (0.8%)	37 of 122 (30.3%)	0 of 121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 31234642Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
Related InfoLink provided by the sponsor.

Related trials for Migraine Disorders

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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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.

Jeff TL Smith, MD study director

Alder Biopharmaceuticals, Inc.

92 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALD403 in people with Migraine Disorders, run by Alder Biopharmaceuticals, Inc. at 92 sites in 4 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 3 inclusion and 8 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 8 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 92 sites in United States, Australia, Georgia, New Zealand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 Mar 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?

75% Migraine Responder Rate (time frame: 12 Weeks). 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 NCT02275117, which also lists 3 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 8 Apr 2020.