Chronic MigrainePhase 2NCT02021773

Assessment of LBR-101 In Chronic Migraine

A Phase 2 study testing LBR-101 High Dose and LBR-101 Low Dose in people with Chronic Migraine, run by Teva Branded Pharmaceutical Products R&D, Inc. at 57 sites in United States.

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 the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Migraine
What is being tested?: LBR-101 High Dose and LBR-101 Low Dose
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 264 participants
Where: 57 sitesUnited States
Study dates: 31 Jan 2014to 31 Mar 2015
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged 18 to 65 years of age.
A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
Chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013)
Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg inclusive.
Demonstrated compliance with the electronic headache diary during the run-in period headache data on a minimum of 22/28 days (80% diary compliance)

Who cannot join

Onset of chronic migraine after the age of 50 years.
Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 6 months prior to study entry.
Subject is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
Failed > 2 medication categories or > 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

United States57 sites

Teva Investigational Site 161
Anaheim, California, 92801
Teva Investigational Site 110
Ann Arbor, Michigan, 48104
Teva Investigational Site 128
Arlington, Texas, 76012
Teva Investigational Site 149
Atlanta, Georgia, 30342
Teva Investigational Site 121
Austin, Texas, 78731
Teva Investigational Site 136
Austin, Texas, 78745
Teva Investigational Site 132
Boulder, Colorado, 80304
Teva Investigational Site 153
Bristol, Tennessee, 37620
Teva Investigational Site 135
Brockton, Massachusetts, 02301
Teva Investigational Site 122
Canton, Ohio, 44718
Teva Investigational Site 123
Charlottesville, Virginia, 22911
Teva Investigational Site 141
Cincinnati, Ohio, 45227
Teva Investigational Site 142
Cincinnati, Ohio, 45229-3039
Teva Investigational Site 155
Cleveland, Ohio, 44195
Teva Investigational Site 102
Columbus, Ohio, 43221
Teva Investigational Site 164
Decatur, Georgia, 30030
Teva Investigational Site 143
DeLand, Florida, 32720
Teva Investigational Site 134
Douglasville, Georgia, 30134
Teva Investigational Site 125
Evansville, Indiana, 47714
Teva Investigational Site 116
Fullerton, California, 92835
Teva Investigational Site 145
Gilbert, Arizona, 85234
Teva Investigational Site 150
Golden Valley, Minnesota, 55422
Teva Investigational Site 120
Goose Creek, South Carolina, 29445
Teva Investigational Site 131
Greensboro, North Carolina, 27405-6962
Teva Investigational Site 137
Hialeah, Florida, 33012
Teva Investigational Site 101
Jacksonville, Florida, 32216
Teva Investigational Site 166
Jacksonville, Florida, 32256
Teva Investigational Site 114
Kalamazoo, Michigan, 49009
Teva Investigational Site 152
Kansas City, Missouri, 64114
Teva Investigational Site 133
Lenexa, Kansas, 66214
Teva Investigational Site 119
Long Beach, California, 90806
Teva Investigational Site 129
Maitland, Florida, 32751
Teva Investigational Site 126
Memphis, Tennessee, 38119
Teva Investigational Site 154
Nashville, Tennessee, 37203
Teva Investigational Site 124
New Bedford, Massachusetts, 02740
Teva Investigational Site 146
Oceanside, California, 92056
Teva Investigational Site 127
Oklahoma City, Oklahoma, 73112
Teva Investigational Site 167
Orlando, Florida, 32801
Teva Investigational Site 139
Ormond Beach, Florida, 32174
Teva Investigational Site 111
Philadelphia, Pennsylvania, 19107
Teva Investigational Site 130
Phoenix, Arizona, 85032
Teva Investigational Site 140
Port Orange, Florida, 32127
Teva Investigational Site 118
Raleigh, North Carolina, 27607
Teva Investigational Site 148
Reno, Nevada, 89502
Teva Investigational Site 144
Roanoke, Virginia, 24018
Teva Investigational Site 113
San Francisco, California, 94109
Teva Investigational Site 117
Scottsdale, Arizona, 85259
Teva Investigational Site 151
Springfield, Massachusetts, 01104
Teva Investigational Site 107
Springfield, Missouri, 65807
Teva Investigational Site 104
St Louis, Missouri, 63141
Teva Investigational Site 162
Stamford, Connecticut, 06905
Teva Investigational Site 108
Stanford, California, 94305
Teva Investigational Site 105
The Bronx, New York, 10461
Teva Investigational Site 112
Walnut Creek, California, 94598
Teva Investigational Site 109
Watertown, Massachusetts, 02472
Teva Investigational Site 168
Winston-Salem, North Carolina, 27103
Teva Investigational Site 115
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine

The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Read the detailed description

Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.

Conditions: Chronic Migraine
Being tested: LBR-101 High Dose, LBR-101 Low Dose, Placebo
Keywords: Headache, Migraine, Chronic Migraine
Medical subject headings: Headache, Migraine Disorders

What participants receive

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

LBR-101 High DoseDrug
Also called Fremanezumab
Subcutaneously Administered LBR-101 Monthly x 3
LBR-101 Low DoseDrug
Also called Fremanezumab
Subcutaneously Administered LBR-101 Monthly x 3
PlaceboDrug
Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Study groups in NCT02021773
Study group	Role	What they receive
LBR-101 High Dose	Experimental	Subcutaneous High Dose LBR-101 Administered Monthly x 3 Receives: Drug: LBR-101 High Dose
LBR-101 Low Dose	Experimental	Subcutaneous Low Dose LBR-101 Administered Monthly x 3 Receives: Drug: LBR-101 Low Dose
Placebo	Placebo comparator	Subcutaneous Placebo Administered Monthly x 3 Receives: Drug: Placebo

What is being measured

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

Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12
A headache day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of hours with headache of any severity during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
Measured: Baseline to week 12
Number of Participants With at Least One Adverse Event
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline to week 12

Secondary outcomes (1)

Mean Change From Baseline in the Number of Headache Days of at Least Moderate Severity Relative to the 28-day Post-treatment Period Ending With Week 12
A headache day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of headache days of at least moderate severity during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or 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.

31 Jan 201431 Mar 2015

First posted27 Dec 2013 (estimated)
Study start31 Jan 2014
Primary completion28 Feb 2015
Study completion31 Mar 2015

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 (4)Papers the sponsor has linked to this study.
Other trials for Chronic MigraineStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02021773
Sponsor's protocol ID: LBR-101-021
Status last verified: Dec 2021
First submitted: 20 Dec 2013
Last updated: 9 Dec 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

VanderPluym J, Dodick DW, Lipton RB, Ma Y, Loupe PS, Bigal ME. Fremanezumab for preventive treatment of migraine: Functional status on headache-free days. Neurology. 2018 Sep 18;91(12):e1152-e1165. doi: 10.1212/01.wnl.0000544321.19316.40. Epub 2018 Aug 17.
PubMed 30120138
Halker Singh RB, Aycardi E, Bigal ME, Loupe PS, McDonald M, Dodick DW. Sustained reductions in migraine days, moderate-to-severe headache days and days with acute medication use for HFEM and CM patients taking fremanezumab: Post-hoc analyses from phase 2 trials. Cephalalgia. 2019 Jan;39(1):52-60. doi: 10.1177/0333102418772585. Epub 2018 May 3.
PubMed 29722276
Cohen JM, Dodick DW, Yang R, Newman LC, Li T, Aycardi E, Bigal ME. Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. Headache. 2017 Oct;57(9):1375-1384. doi: 10.1111/head.13156. Epub 2017 Sep 1.
PubMed 28862758
Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R, Silberstein SD. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015 Nov;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. Epub 2015 Sep 30.
PubMed 26432181

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 at a glance

From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine
ClinicalTrials.gov ID: NCT02021773
Acronym / sponsor ID: LBR-101-021
Conditions: Chronic Migraine
Keywords: Headache, Migraine, Chronic Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jan 2014 (actual)
Primary completion: 28 Feb 2015 (actual)
Study completion: 31 Mar 2015 (actual)
First posted: 27 Dec 2013 (estimated)
Results: Posted 1 Nov 2021

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 the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
LBR-101 High Dose	Experimental	Drug: LBR-101 High DoseSubcutaneous High Dose LBR-101 Administered Monthly x 3
LBR-101 Low Dose	Experimental	Drug: LBR-101 Low DoseSubcutaneous Low Dose LBR-101 Administered Monthly x 3
Placebo	Placebo comparator	Drug: PlaceboSubcutaneous Placebo Administered Monthly x 3

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females aged 18 to 65 years of age.
A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
Chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013)
Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg inclusive.
Demonstrated compliance with the electronic headache diary during the run-in period headache data on a minimum of 22/28 days (80% diary compliance)

Key exclusion criteria (5 listed)

Onset of chronic migraine after the age of 50 years.
Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 6 months prior to study entry.
Subject is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
Failed > 2 medication categories or > 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.

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
LBR-101 High DoseAlso: FremanezumabSubcutaneously Administered LBR-101 Monthly x 3	Drug	LBR-101 High Dose
LBR-101 Low DoseAlso: FremanezumabSubcutaneously Administered LBR-101 Monthly x 3	Drug	LBR-101 Low Dose
PlaceboSubcutaneously Administered Placebo (Vehicle) Monthly x 3	Drug	Placebo

Primary outcome

Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12
Time frame: Baseline to week 12
A headache day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of hours with headache of any severity during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.
Number of Participants With at Least One Adverse Event
Time frame: Baseline to week 12
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

1 secondary outcome

Mean Change From Baseline in the Number of Headache Days of at Least Moderate Severity Relative to the 28-day Post-treatment Period Ending With Week 12
Time frame: Baseline to week 12

Results and safety

Results posted to the registry on 1 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	89	77
LBR-101 Low Dose	88	72
LBR-101 High Dose	87	76

Primary outcome: Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12

Time frame: Baseline to week 12. Least squares mean (Standard Error). Unit: Number of monthly headache hours

Measure	Placebo n = 89	LBR-101 Low Dose n = 87	LBR-101 High Dose n = 85
Value	-37.10 (8.42)	-59.84 (8.62)	-67.51 (8.61)

Placebo vs LBR-101 Low Dose: Mean Difference (Final Values): -22.74 (95% CI -44.28 to -1.21), p = 0.0386, Mixed Models Analysis
Placebo vs LBR-101 High Dose: Mean Difference (Final Values): -30.41 (95% CI -51.88 to -8.95), p = 0.0057, Mixed Models Analysis

Population analysed: Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug and obtained at least one endpoint measurement.

Primary outcome: Number of Participants With at Least One Adverse Event

Time frame: Baseline to week 12. Count of participants. Unit: Participants

Measure	Placebo n = 89	LBR-101 Low Dose n = 88	LBR-101 High Dose n = 86
Value	36	47	41

Population analysed: Safety analysis set included all randomized participants who received at least one dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 12 weeks after first dose of treatment drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 89 (1.1%)	3 of 89 (3.4%)	0 of 89
LBR-101 Low Dose	1 of 88 (1.1%)	6 of 88 (6.8%)	0 of 88
LBR-101 High Dose	2 of 86 (2.3%)	8 of 86 (9.3%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30120138VanderPluym J, Dodick DW, Lipton RB, Ma Y, Loupe PS, Bigal ME. Fremanezumab for preventive treatment of migraine: Functional status on headache-free days. Neurology. 2018 Sep 18;91(12):e1152-e1165. doi: 10.1212/01.wnl.0000544321.19316.40. Epub 2018 Aug 17.
Derived from this study: PubMed 29722276Halker Singh RB, Aycardi E, Bigal ME, Loupe PS, McDonald M, Dodick DW. Sustained reductions in migraine days, moderate-to-severe headache days and days with acute medication use for HFEM and CM patients taking fremanezumab: Post-hoc analyses from phase 2 trials. Cephalalgia. 2019 Jan;39(1):52-60. doi: 10.1177/0333102418772585. Epub 2018 May 3.
Derived from this study: PubMed 28862758Cohen JM, Dodick DW, Yang R, Newman LC, Li T, Aycardi E, Bigal ME. Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. Headache. 2017 Oct;57(9):1375-1384. doi: 10.1111/head.13156. Epub 2017 Sep 1.
Derived from this study: PubMed 26432181Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R, Silberstein SD. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015 Nov;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. Epub 2015 Sep 30.

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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.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

57 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LBR-101 High Dose and LBR-101 Low Dose in people with Chronic Migraine, run by Teva Branded Pharmaceutical Products R&D, Inc. at 57 sites in United States.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 Nov 2021). 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?

Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12 (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02021773, which also lists 4 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.