Relapsing Remitting Multiple SclerosisPhase 2NCT01963611

Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

A Phase 2 study testing Plovamer acetate 0.5 milligram (mg), Copaxone 20 mg and Plovamer acetate 3 mg in people with Relapsing Remitting Multiple Sclerosis, run by EMD Serono at 118 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Relapsing Remitting Multiple Sclerosis
What is being tested?: Plovamer acetate 0.5 milligram (mg), Copaxone 20 mg and Plovamer acetate 3 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 118 sitesin 17 countries
Study dates: Oct 2013to 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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female, between the ages of 18 and 60 years
Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)
Other protocol defined inclusion criteria could apply

Who cannot join

Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI
Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
Contraindication to Copaxone use
Other protocol defined exclusion criteria could apply

Trial locations and contacts

118 sites in 17 countries.

Country

City, postcode or hospital

118 sites in 17 countries

United States35 sites

Research site
Baltimore, Maryland, 21287
Research site
Charlotte, North Carolina, 28209
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Cincinnati, Ohio, 45206
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Columbus, Georgia, 31909
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Dayton, Ohio, 45417
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Detroit, Michigan, 48202-2689
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Detroit, Michigan, 97205
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Dover, Delaware, 19901
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Elk Grove Village, Illinois, 60007
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Fairfield, Connecticut, 06824
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Golden Valley, Minnesota, 55422
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Hickory, North Carolina, 28602
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Indianapolis, Indiana, 46256
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Matthews, North Carolina, 28105
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Miami, Florida, 33136
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Naples, Florida, 34102
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Nashville, Tennessee, 37205
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New Bedford, Massachusetts, 02740
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Plainview, New York, 11803
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Pompano Beach, Florida, 33060
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Raleigh, North Carolina, 27607-6010
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Redding, California, 96001
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Roanoke, Virginia, 24018
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Rome, Georgia, 30165
Research Site
Round Rock, Texas, 78681
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San Antonio, Texas, 78258
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San Diego, California, 92117
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San Diego, California, 92128
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Sarasota, Florida, 34233
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St Louis, Missouri, 63110
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Sunrise, Florida, 33351
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Tacoma, Washington, 98405
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Willow Grove, Pennsylvania, 19090
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Wilmington, North Carolina, 28401
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Worcester, Massachusetts, 01655

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Russia10 sites

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Krasnoyarsk
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Kursk
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Rostov-on-Don
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Saint Petersburg
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Saransk
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Ufa
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Yekaterinburg

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Italy8 sites

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Castelfiorentino
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Catania
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Cefalù
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Milan
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Montichiari
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Parma
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Roma

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Mexico7 sites

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Cuautitlán Izcalli
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León
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México
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Mexico City
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Monterrey
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Poland7 sites

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Katowice
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Lodz
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Poznan
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Warsaw

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Ukraine7 sites

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Dnipropetrovsk
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Ivano-Frankivsk
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Kyiv
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Lutsk
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Vinnytsia
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Czechia6 sites

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Havířov
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Hradec Králové
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Prague

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Spain6 sites

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Córdoba
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Madrid
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Turkey (Türkiye)6 sites

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United Kingdom5 sites

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Sheffield
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Southampton
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Hungary4 sites

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Budapest
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Debrecen
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Esztergom
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Miskolc

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Bulgaria3 sites

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Blagoevgrad
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Dupnitsa
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Sofia

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Croatia3 sites

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Osijek
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Varaždin
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Zagreb

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Finland3 sites

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Kuopio
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Oulu
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Turku

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Serbia3 sites

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Belgrade
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Kragujevac
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Niš

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South Africa3 sites

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Cape Town
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Durban
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Pretoria

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Greece2 sites

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Athens
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Thessaloniki

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About this study

Official title: A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis
Being tested: Plovamer acetate 0.5 milligram (mg), Copaxone 20 mg, Plovamer acetate 3 mg, Plovamer acetate 10 mg, Plovamer acetate 20 mg
Keywords: Multiple Sclerosis, Relapsing Remitting, Plovamer acetate, Copaxone
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

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

Plovamer acetate 0.5 milligram (mg)Drug
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Copaxone 20 mgDrug
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate 3 mgDrug
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate 10 mgDrug
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Plovamer acetate 20 mgDrug
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Study groups in NCT01963611
Study group	Role	What they receive
Plovamer acetate 0.5 milligram (mg)	Experimental	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. Receives: Drug: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate 3 mg	Experimental	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. Receives: Drug: Plovamer acetate 3 mg
Plovamer acetate 10 mg	Experimental	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. Receives: Drug: Plovamer acetate 10 mg
Plovamer acetate 20 mg	Experimental	Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months. Receives: Drug: Plovamer acetate 20 mg
Copaxone 20 mg	Active comparator	Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months. Receives: Drug: Copaxone 20 mg

What is being measured

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

Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Measured: Baseline , Week 12, 24, 28, 32, 36, 40

Secondary outcomes (9)

Mean Annualized Relapse Rate (ARR)
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).
Measured: Baseline up to Week 40
Percentage of Subjects Remaining Relapse-Free
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.
Measured: Baseline up to Week 40
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Measured: Weeks 12, 24, 28, 32, 36, 40
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.
Measured: Weeks 12, 24, 28, 32, 36,40
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.
Measured: Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.
Measured: Baseline, Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.
Measured: Baseline, Weeks 12, 24, 28, 32, 36, 40
Time to First Relapse
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.
Measured: Baseline up to Week 40
Mean Change From Baseline in Brain Volume Per Subject
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Measured: Baseline, Weeks 24, 28, 32, 36, 40

Timeline

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

Oct 2013Mar 2015

First posted16 Oct 2013 (estimated)
Study startOct 2013
Primary completionMar 2015
Study completionMar 2015

Why it stopped: Study was terminated based on sponsor discretion.

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.
Other trials for Relapsing Remitting Multiple SclerosisStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01963611
Sponsor's protocol ID: EMR200575-001
Other IDs: 2013-002283-25
Status last verified: Apr 2016
First submitted: 11 Oct 2013
Last updated: 11 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
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Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
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Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
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All Relapsing Remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT01963611
Acronym / sponsor ID: EMR200575-001
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis, Relapsing Remitting, Plovamer acetate, Copaxone
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated based on sponsor discretion.
Enrolment: 255 participants (actual)
Lead sponsor: EMD SeronoIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 16 Oct 2013 (estimated)
Results: Posted 11 May 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Plovamer acetate 0.5 milligram (mg)	Experimental	Drug: Plovamer acetate 0.5 milligram (mg)Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate 3 mg	Experimental	Drug: Plovamer acetate 3 mgPlovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate 10 mg	Experimental	Drug: Plovamer acetate 10 mgPlovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate 20 mg	Experimental	Drug: Plovamer acetate 20 mgPlovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Copaxone 20 mg	Active comparator	Drug: Copaxone 20 mgCopaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female, between the ages of 18 and 60 years
Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)
Other protocol defined inclusion criteria could apply

Key exclusion criteria (5 listed)

Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI
Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
Contraindication to Copaxone use
Other protocol defined exclusion criteria could apply

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
Plovamer acetate 0.5 milligram (mg)Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug	Plovamer acetate 0.5 milligram (mg)
Copaxone 20 mgPlovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug	Copaxone 20 mg
Plovamer acetate 3 mgPlovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug	Plovamer acetate 3 mg
Plovamer acetate 10 mgPlovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.	Drug	Plovamer acetate 10 mg
Plovamer acetate 20 mgCopaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.	Drug	Plovamer acetate 20 mg

Primary outcome

Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time frame: Baseline , Week 12, 24, 28, 32, 36, 40
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.

9 secondary outcomes

Mean Annualized Relapse Rate (ARR)
Time frame: Baseline up to Week 40
Percentage of Subjects Remaining Relapse-Free
Time frame: Baseline up to Week 40
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time frame: Weeks 12, 24, 28, 32, 36, 40
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Time frame: Weeks 12, 24, 28, 32, 36,40
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Time frame: Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Time to First Relapse
Time frame: Baseline up to Week 40
Mean Change From Baseline in Brain Volume Per Subject
Time frame: Baseline, Weeks 24, 28, 32, 36, 40

Results and safety

Results posted to the registry on 11 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plovamer Acetate 0.5 Milligram (mg)	51	0
Plovamer Acetate 3 mg	49	0
Plovamer Acetate 10 mg	52	0
Plovamer Acetate 20 mg	52	0
Copaxone 20 mg	51	0

Primary outcome: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

Time frame: Baseline , Week 12, 24, 28, 32, 36, 40. Mean (Standard Deviation). Unit: lesions per subjects per scan

Measure	Plovamer Acetate 0.5 Milligram (mg) n = 45	Plovamer Acetate 3 mg n = 45	Plovamer Acetate 10 mg n = 43	Plovamer Acetate 20 mg n = 41	Copaxone 20 mg n = 44
Baseline (n=44,45,42,41,44)	1.5 (2.93)	1.6 (4.12)	1.0 (2.43)	2.3 (5.65)	2.5 (5.12)
Week 12: (n=44,45,43,41,44)	1.7 (3.28)	1.3 (3.55)	1.2 (2.40)	1.5 (3.70)	1.7 (4.51)
Week 24: (n=17,17,21,18,19)	1.5 (2.53)	0.9 (2.33)	1.5 (4.14)	1.1 (1.92)	0.6 (1.46)
Week 28: (n=10,11,13,12,13)	1.7 (2.75)	0.4 (0.92)	0.5 (1.20)	2.0 (4.00)	0.9 (1.89)
Week 32: (n=5,6,9,10,9)	1.0 (1.41)	0.2 (0.41)	0.8 (1.72)	1.8 (3.33)	1.2 (3.67)
Week 36: (n=1,0,2,3,3)	0.0 (NA)	NA (NA)	1.0 (1.41)	1.3 (2.31)	7.3 (12.70)
Week 40: (n=1,0,1,1,1)	0.0 (NA)	NA (NA)	0.0 (NA)	0.0 (NA)	16.0 (NA)

Population analysed: Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to end of treatment (week 40). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plovamer Acetate 0.5 Milligram (mg)	2 of 51 (3.9%)	28 of 51 (54.9%)	Not reported
Plovamer Acetate 3 mg	0 of 49 (0%)	34 of 49 (69.4%)	Not reported
Plovamer Acetate 10 mg	2 of 52 (3.8%)	38 of 52 (73.1%)	Not reported
Plovamer Acetate 20 mg	3 of 52 (5.8%)	41 of 52 (78.8%)	Not reported
Copaxone 20 mg	0 of 50 (0%)	42 of 50 (84%)	Not reported

Limitations and caveats (from the sponsor): Based on Sponsor decision to discontinue the clinical development program of plovamer acetate therapy for multiple sclerosis the trial was prematurely terminated

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Responsible study director

EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany

118 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: stopped early, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Russia, Italy, Mexico, Poland and 12 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. 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 11 May 2016). 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 Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan (time frame: Baseline , Week 12, 24, 28, 32, 36, 40). 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 NCT01963611.

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 11 May 2016.