Clinical trial NCT01963611: Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Relapsing Remitting
Plovamer acetate
Copaxone
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
timeFrame: Baseline , Week 12, 24, 28, 32, 36, 40
Secondary outcomes:
measure: Mean Annualized Relapse Rate (ARR)
timeFrame: Baseline up to Week 40
measure: Percentage of Subjects Remaining Relapse-Free
timeFrame: Baseline up to Week 40
measure: Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
timeFrame: Weeks 12, 24, 28, 32, 36, 40
measure: Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
timeFrame: Weeks 12, 24, 28, 32, 36,40
measure: Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
timeFrame: Weeks 12, 24, 28, 32, 36, 40
measure: Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
timeFrame: Baseline, Weeks 12, 24, 28, 32, 36, 40
measure: Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
timeFrame: Baseline, Weeks 12, 24, 28, 32, 36, 40
measure: Time to First Relapse
timeFrame: Baseline up to Week 40
measure: Mean Change From Baseline in Brain Volume Per Subject
timeFrame: Baseline, Weeks 24, 28, 32, 36, 40
Other outcomes:
Locations:
city: Redding
country: United States
facility: Research site
state: California
city: San Diego
country: United States
facility: Research site
state: California
city: San Diego
country: United States
facility: Research site
state: California
city: Fairfield
country: United States
facility: Research site
state: Connecticut
city: Dover
country: United States
facility: Research site
state: Delaware
city: Miami
country: United States
facility: Research site
state: Florida
city: Naples
country: United States
facility: Research site
state: Florida
city: Pompano Beach
country: United States
facility: Research site
state: Florida
city: Sarasota
country: United States
facility: Research site
state: Florida
city: Sunrise
country: United States
facility: Research site
state: Florida
city: Columbus
country: United States
facility: Research site
state: Georgia
city: Rome
country: United States
facility: Research site
state: Georgia
city: Elk Grove Village
country: United States
facility: Research site
state: Illinois
city: Indianapolis
country: United States
facility: Research site
state: Indiana
city: Baltimore
country: United States
facility: Research site
state: Maryland
city: New Bedford
country: United States
facility: Research site
state: Massachusetts
city: Worcester
country: United States
facility: Research site
state: Massachusetts
city: Detroit
country: United States
facility: Research site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Golden Valley
country: United States
facility: Research site
state: Minnesota
city: St Louis
country: United States
facility: Research site
state: Missouri
city: Plainview
country: United States
facility: Research site
state: New York
city: Charlotte
country: United States
facility: Research site
state: North Carolina
city: Hickory
country: United States
facility: Research site
state: North Carolina
city: Matthews
country: United States
facility: Research site
state: North Carolina
city: Raleigh
country: United States
facility: Research site
state: North Carolina
city: Wilmington
country: United States
facility: Research site
state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Dayton
country: United States
facility: Research site
state: Ohio
city: Willow Grove
country: United States
facility: Research site
state: Pennsylvania
city: Nashville
country: United States
facility: Research site
state: Tennessee
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Roanoke
country: United States
facility: Research site
state: Virginia
city: Tacoma
country: United States
facility: Research site
state: Washington
city: Blagoevgrad
country: Bulgaria
facility: Research site
city: Dupnitsa
country: Bulgaria
facility: Research site
city: Sofia
country: Bulgaria
facility: Research site
city: Osijek
country: Croatia
facility: Research site
city: Varazdin
country: Croatia
facility: Research site
city: Zagreb
country: Croatia
facility: Research site
city: Brno
country: Czech Republic
facility: Research site
city: Havirov
country: Czech Republic
facility: Research site
city: Hradec Kralove
country: Czech Republic
facility: Research site
city: Jihlava
country: Czech Republic
facility: Research site
city: Olomouc
country: Czech Republic
facility: Research site
city: Praha
country: Czech Republic
facility: Research site
city: Kuopio
country: Finland
facility: Research site
city: Oulu
country: Finland
facility: Research site
city: Turku
country: Finland
facility: Research site
city: Athens
country: Greece
facility: Research site
city: Thessaloniki
country: Greece
facility: Research site
city: Budapest
country: Hungary
facility: Research site
city: Debrecen
country: Hungary
facility: Research site
city: Esztergom
country: Hungary
facility: Research site
city: Miskolc
country: Hungary
facility: Research site
city: Castelfiorentino
country: Italy
facility: Research site
city: Catania
country: Italy
facility: Research site
city: Cefalù
country: Italy
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Modena
country: Italy
facility: Research site
city: Montichiari
country: Italy
facility: Research site
city: Parma
country: Italy
facility: Research site
city: Roma
country: Italy
facility: Research site
city: Cuautitlan Izcalli
country: Mexico
facility: Research site
city: Leon
country: Mexico
facility: Research site
city: Mexico City
country: Mexico
facility: Research site
city: Mexico
country: Mexico
facility: Research site
city: Monterrey
country: Mexico
facility: Research site
city: Morelia
country: Mexico
facility: Research site
city: Tlalnepantla
country: Mexico
facility: Research site
city: Gdansk
country: Poland
facility: Research site
city: Katowice
country: Poland
facility: Research site
city: Lodz
country: Poland
facility: Research site
city: Olsztyn
country: Poland
facility: Research site
city: Poznan
country: Poland
facility: Research site
city: Rzeszow
country: Poland
facility: Research site
city: Warsaw
country: Poland
facility: Research site
city: Warszawa
country: Poland
facility: Research site
city: Ekaterinburg
country: Russian Federation
facility: Research site
city: Krasnoyarsk
country: Russian Federation
facility: Research site
city: Kursk
country: Russian Federation
facility: Research site
city: Moscow
country: Russian Federation
facility: Research site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research site
city: Novosibirsk
country: Russian Federation
facility: Research site
city: Rostov-on-Don
country: Russian Federation
facility: Research site
city: Saransk
country: Russian Federation
facility: Research site
city: St Petersburg
country: Russian Federation
facility: Research site
city: St. Petersburg
country: Russian Federation
facility: Research site
city: Ufa
country: Russian Federation
facility: Research site
city: Belgrade
country: Serbia
facility: Research site
city: Kragujevac
country: Serbia
facility: Research site
city: Nis
country: Serbia
facility: Research site
city: Cape Town
country: South Africa
facility: Research site
city: Durban
country: South Africa
facility: Research site
city: Pretoria
country: South Africa
facility: Research site
city: Aranjuez
country: Spain
facility: Research site
city: Córdoba
country: Spain
facility: Research site
city: Madrid
country: Spain
facility: Research site
city: Mostoles
country: Spain
facility: Research site
city: Santander
country: Spain
facility: Research site
city: Zaragoza
country: Spain
facility: Research site
city: Diyarbakir
country: Turkey
facility: Research site
city: Edirne
country: Turkey
facility: Research site
city: Istanbul
country: Turkey
facility: Research site
city: Kocaeli
country: Turkey
facility: Research site
city: Mersin
country: Turkey
facility: Research site
city: Samsun
country: Turkey
facility: Research site
city: Dnipropetrovsk
country: Ukraine
facility: Research site
city: Ivano-Frankivsk
country: Ukraine
facility: Research site
city: Kyiv
country: Ukraine
facility: Research site
city: Lutsk
country: Ukraine
facility: Research site
city: Simferopol
country: Ukraine
facility: Research site
city: Vinnytsia
country: Ukraine
facility: Research site
city: Zaporizhzhia
country: Ukraine
facility: Research site
city: Exeter
country: United Kingdom
facility: Research site
city: Hull
country: United Kingdom
facility: Research site
city: Sheffield
country: United Kingdom
facility: Research site
city: Southampton
country: United Kingdom
facility: Research site
city: Stoke on Trent
country: United Kingdom
facility: Research site
Study officials:
affiliation: EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: