Multiple SclerosisPhase 2SYNERGYNCT01864148
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
A Phase 2 study testing BIIB033 and Avonex in people with Multiple Sclerosis, run by Biogen at 72 sites in 12 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when… Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BIIB033 and Avonex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 72 sitesin 12 countries
- Study dates
- Aug 2013to Mar 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 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
- All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
Who cannot join
- A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
- Previous history of clinically significant disease.
- Plans to undergo elective major procedures/surgeries at any time during the study.
- Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
- RRMS subjects with any history of inadequate response to any approved interferon β preparation
- History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
- History or evidence of drug or alcohol abuse within 2 years prior to randomization
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
72 sites in 12 countries.
72 sites in 12 countries
United States11 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Immunoe International Research Center
Centennial, Colorado, 80112
North Central Neurology Assoc PC
Cullman, Alabama, 35058
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, 48334
Multiple Sclerosis Center of North Eastern New York
Latham, New York, 12110
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, 73104
Phoenix Neurological Associates
Phoenix, Arizona, 85018
Raleigh Neurology Associates PA
Raleigh, California, 27607-6000
Swedish Medical Center
Seattle, Washington, 98122
Washington University
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Poland11 sites
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, 80-803
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziądz, 86-300
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Silesian Voivodeship, 40-650
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
Katowice, 40-595
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
Katowice, 40-749
Centrum Neurologii K. Selmaj
Lódz, Lódzkie, 93-121
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
Plewiska, 62-064
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, 61-853
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
Rybnik, 44-200
EUROMEDIS Sp. z o.o.
Szczecin, 70-215
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, 00-901
Spain8 sites
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 8035
Hospital de Basurto Osakidetza
Bilbao, Vizcaya, 48013
Hospital Universitario Reina Sofia
Córdoba, Córdoba, 14008
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Hospital Clinico San Carlos
Madrid, Madrid, Communidad Delaware, 28040
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital General Carlos Haya
Málaga, 29010
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071
France7 sites
Hôpital Sud
Amiens, Somme, 80054
Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Hôpital Roger Salengro
Lille, Nord, 59000
CHRU Nancy
Nancy, 54000
Hôpital Guillaume Et René Laënnec
Nantes, Loire-Atlantique, 44805
Fondation Rothschild
Paris, 75019
Hôpital Maison Blanche
Reims, Marne, 51092
Canada6 sites
Research Site
Gatinueau, Quebec
Research Site
Greenfield Park, Quebec
Research Site
Lévis, Quebec
London Health Sciences Centre
London, N6A 5A5
Research Site
Montreal, Quebec
Research Site
Ottowa, Ontario
Czechia6 sites
NEUROSPOL Sro
Havířov, 736 01
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Hradec Králové Region, 500 05
Nemocnice Jihlava Prispevkova Organizace
Jihlava, Vysocina, 586 33
Vseobecna Fakultni Nemocnice V Praze
Prague, Hlavní Mesto, 128 08
Fakultni nemocnice v Motole
Prague, 150 06
Krajska Zdravotni a.s. Nemocnice Teplice Oz
Teplice, Ústí nad Labem Region, 415 29
Italy6 sites
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
Catania, Sicily, 95123
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, 90015
Azienda Ospedaliera S. Antonio Abate di Gallarate
Gallarate, Varese, 21013
Azienda Ospedaliera Universitaria San Martino
Genoa, Liguria, 16132
Ospedale San Raffaele S.r.l.
Milan, Lombardy, 20127
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
Montichiari, Lombardy, 25018
Russia6 sites
Kaluga Regional Hospital
Kaluga, 248007
Republican Clinical Hospital For Rehabilitation Treatment
Kazan', 420021
Krasnoyarsk State Medical Academy
Krasnoyarsk, 660049
Perm State Medical Academy
Perm, 614990
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Saint Petersburg, 197110
Regional Clinical Hospital #3
Volgograd, 400001
Hungary4 sites
Uzsoki Utcai Korhaz
Budapest, 1145
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
Budapest, 1204
Pécsi Tudományegyetem
Pécs, 7623
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6725
Serbia4 sites
Clinical Center of Serbia
Belgrade, Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Center Kragujevac
Kragujevac, 34000
General Hospital Uzice
Užice, 31000
Netherlands2 sites
Erasmus MC
Rotterdam, South Holland, 3015 CE
Zuyderland Medisch Centrum
Sittard-Geleen, 6162 BG
United Kingdom1 site
Queen's Medical Centre
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.
Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
- Conditions
- Multiple Sclerosis
- Being tested
- BIIB033, Placebo, Avonex
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB033Drug
Also called anti-LINGO-1 mAb
PlaceboOther
AvonexDrug
Also called interferon beta-1a
| Study group | Role | What they receive |
|---|---|---|
| BIIB033, 3 mg/kg | Experimental | BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84. Receives: Drug: BIIB033; Drug: Avonex |
| BIIB033, 10 mg/kg | Experimental | BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84. Receives: Drug: BIIB033; Drug: Avonex |
| BIIB033, 30 mg/kg | Experimental | BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84. Receives: Drug: BIIB033; Drug: Avonex |
| BIIB033, 100 mg/kg | Experimental | BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84. Receives: Drug: BIIB033; Drug: Avonex |
| Placebo | Placebo comparator | Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84. Receives: Other: Placebo; Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Measured: 72 weeks
Secondary outcomes (3)
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.
Measured: 72 weeks
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.
Measured: Up to 84 weeks
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Measured: Up to 84 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionMar 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 (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864148
- Sponsor's protocol ID
- 215MS201
- Other IDs
- 2011-006262-40
- Acronym
- SYNERGY
- Status last verified
- Mar 2017
- First submitted
- 24 May 2013
- Last updated
- 3 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
PubMed 31285147Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
PubMed 26396053
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
- ClinicalTrials.gov ID
- NCT01864148
- Acronym / sponsor ID
- SYNERGY / 215MS201
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Posted 3 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.
Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BIIB033, 3 mg/kg | Experimental | Drug: BIIB033, Drug: AvonexBIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84. |
| BIIB033, 10 mg/kg | Experimental | Drug: BIIB033, Drug: AvonexBIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 30 mg/kg | Experimental | Drug: BIIB033, Drug: AvonexBIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 100 mg/kg | Experimental | Drug: BIIB033, Drug: AvonexBIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| Placebo | Placebo comparator | Other: Placebo, Drug: AvonexPlacebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
- RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
- All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
Key exclusion criteria (8 listed)
- A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
- Previous history of clinically significant disease.
- Plans to undergo elective major procedures/surgeries at any time during the study.
- Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
- RRMS subjects with any history of inadequate response to any approved interferon β preparation
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 |
|---|---|---|
| BIIB033Also: anti-LINGO-1 mAb | Drug | BIIB033, 10 mg/kg, BIIB033, 100 mg/kg, BIIB033, 3 mg/kg, BIIB033, 30 mg/kg |
| Placebo | Other | Placebo |
| AvonexAlso: interferon beta-1a | Drug | BIIB033, 10 mg/kg, BIIB033, 100 mg/kg, BIIB033, 3 mg/kg, BIIB033, 30 mg/kg, Placebo |
Primary outcome
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint
Time frame: 72 weeks
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
3 secondary outcomes
Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint
Time frame: 72 weeks
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs
Time frame: Up to 84 weeks
Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84
Time frame: Up to 84 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31285147Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
- Derived from this study: PubMed 26396053Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
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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.
Medical Director study director
Biogen
72 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB033 and Avonex in people with Multiple Sclerosis, run by Biogen at 72 sites in 12 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Poland, Spain, France, Canada and 7 more countries. 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 3 May 2017). 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?
Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint (time frame: 72 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 NCT01864148, which also lists 2 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 3 May 2017.