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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01963611
Other study ID # EMR200575-001
Secondary ID 2013-002283-25
Status Completed
Phase Phase 2
First received October 11, 2013
Last updated July 24, 2015
Start date October 2013
Est. completion date March 2015

Study information

Verified date July 2015
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Plovamer acetate 0.5 milligram (mg)
Plovamer acetate will be administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
Copaxone 20 mg
Copaxone will be administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
Plovamer acetate 3 mg
Plovamer acetate will be administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
Plovamer acetate 10 mg
Plovamer acetate will be administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
Plovamer acetate 20 mg
Plovamer acetate will be administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.

Locations

Country Name City State
Bulgaria Research site Blagoevgrad
Bulgaria Research site Dupnitsa
Bulgaria Research site Sofia
Croatia Research site Osijek
Croatia Research site Varazdin
Croatia Research site Zagreb
Czech Republic Research site Brno
Czech Republic Research site Havirov
Czech Republic Research site Hradec Kralove
Czech Republic Research site Jihlava
Czech Republic Research site Olomouc
Czech Republic Research site Praha
Finland Research site Kuopio
Finland Research site Oulu
Finland Research site Turku
Greece Research site Athens
Greece Research site Thessaloniki
Hungary Research site Budapest
Hungary Research site Debrecen
Hungary Research site Esztergom
Hungary Research site Miskolc
Italy Research site Castelfiorentino
Italy Research site Catania
Italy Research site Cefalù
Italy Research site Milano
Italy Research site Modena
Italy Research site Montichiari
Italy Research site Parma
Italy Research site Roma
Mexico Research site Cuautitlan Izcalli
Mexico Research site Leon
Mexico Research site Mexico
Mexico Research site Mexico City
Mexico Research site Monterrey
Mexico Research site Morelia
Mexico Research site Tlalnepantla
Poland Research site Gdansk
Poland Research site Katowice
Poland Research site Lodz
Poland Research site Olsztyn
Poland Research site Poznan
Poland Research site Rzeszow
Poland Research site Warsaw
Poland Research site Warszawa
Russian Federation Research site Ekaterinburg
Russian Federation Research site Krasnoyarsk
Russian Federation Research site Kursk
Russian Federation Research site Moscow
Russian Federation Research site Nizhniy Novgorod
Russian Federation Research site Novosibirsk
Russian Federation Research site Rostov-on-Don
Russian Federation Research site Saransk
Russian Federation Research site St Petersburg
Russian Federation Research site St. Petersburg
Russian Federation Research site Ufa
Serbia Research site Belgrade
Serbia Research site Kragujevac
Serbia Research site Nis
South Africa Research site Cape Town
South Africa Research site Durban
South Africa Research site Pretoria
Spain Research site Aranjuez
Spain Research site Córdoba
Spain Research site Madrid
Spain Research site Mostoles
Spain Research site Santander
Spain Research site Zaragoza
Turkey Research site Diyarbakir
Turkey Research site Edirne
Turkey Research site Istanbul
Turkey Research site Kocaeli
Turkey Research site Mersin
Turkey Research site Samsun
Ukraine Research site Dnipropetrovsk
Ukraine Research site Ivano-Frankivsk
Ukraine Research site Kyiv
Ukraine Research site Lutsk
Ukraine Research site Simferopol
Ukraine Research site Vinnytsia
Ukraine Research site Zaporizhzhia
United Kingdom Research site Exeter
United Kingdom Research site Hull
United Kingdom Research site Sheffield
United Kingdom Research site Southampton
United Kingdom Research site Stoke on Trent
United States Research site Baltimore Maryland
United States Research site Charlotte North Carolina
United States Research site Cincinnati Ohio
United States Research site Columbus Georgia
United States Research site Dayton Ohio
United States Research site Detroit Michigan
United States Research Site Detroit Michigan
United States Research site Dover Delaware
United States Research site Elk Grove Village Illinois
United States Research site Fairfield Connecticut
United States Research site Golden Valley Minnesota
United States Research site Hickory North Carolina
United States Research site Indianapolis Indiana
United States Research site Matthews North Carolina
United States Research site Miami Florida
United States Research site Naples Florida
United States Research site Nashville Tennessee
United States Research site New Bedford Massachusetts
United States Research site Plainview New York
United States Research site Pompano Beach Florida
United States Research site Raleigh North Carolina
United States Research site Redding California
United States Research site Roanoke Virginia
United States Research site Rome Georgia
United States Research Site Round Rock Texas
United States Research Site San Antonio Texas
United States Research site San Diego California
United States Research site San Diego California
United States Research site Sarasota Florida
United States Research site St Louis Missouri
United States Research site Sunrise Florida
United States Research site Tacoma Washington
United States Research site Willow Grove Pennsylvania
United States Research site Wilmington North Carolina
United States Research site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Czech Republic,  Finland,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean number of Time Constant 1 (T1) Gadolinium (Gd)-enhancing lesions per subject and scan from 5 serial magnetic resonance imaging (MRI) scans on Weeks 24, 28, 32, 36 and 40 Up to Week 40 No
Secondary Mean annualized relapse rate (ARR) Up to Week 40 No
Secondary Percentage of subjects remaining relapse-free Week 40 No
Secondary Mean number of new T1 Gd-enhancing lesions per subject and scan from 5 serial MRI scans Weeks 24, 28, 32, 36, and 40 No
Secondary Mean number of new or enlarging Time Constant 2 (T2) lesions per subject and scan from 5 serial MRI scans Weeks 24, 28, 32, 36, and 40 No
Secondary Mean number of new, unenhancing T1 lesions (black holes) per subject and scan from 5 serial MRIs Weeks 24, 28, 32, 36, and 40 No
Secondary Mean change in volume of T1 Gd-enhancing lesions per subject, baseline versus mean of 5 serial MRI scans at Weeks 24, 28, 32, 36, and 40 Baseline, Weeks 24, 28, 32, 36, and 40 No
Secondary Mean change per subjects in volume of T2 Gd-enhancing lesions baseline versus last MRI scan between Weeks 24 and 40 Baseline, Weeks 24, 28, 32, 36, and 40 No
Secondary Time to first relapse Up to Week 40 No
Secondary Mean change in brain volume per subject, baseline versus last MRI performed between Weeks 24 and 40 Baseline, Weeks 24, 28, 32, 36, and 40 No
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