Back to resultsEfficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Plovamer acetate 0.5 milligram (mg)
Copaxone 20 mg
Plovamer acetate 3 mg
Plovamer acetate 10 mg
Plovamer acetate 20 mg
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing Remitting, Plovamer acetate, Copaxone
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Plovamer acetate 0.5 milligram (mg)
Plovamer acetate 3 mg
Plovamer acetate 10 mg
Plovamer acetate 20 mg
Copaxone 20 mg
Arm Description
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 was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
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 was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
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.
Mean Change From Baseline in Brain Volume Per Subject
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01963611
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated based on sponsor discretion.
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Relapsing Remitting, Plovamer acetate, Copaxone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plovamer acetate 0.5 milligram (mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Plovamer acetate 3 mg
Arm Type
Experimental
Arm Description
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Arm Title
Plovamer acetate 10 mg
Arm Type
Experimental
Arm Description
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Arm Title
Plovamer acetate 20 mg
Arm Type
Experimental
Arm Description
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Arm Title
Copaxone 20 mg
Arm Type
Active Comparator
Arm Description
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Intervention Type
Drug
Intervention Name(s)
Plovamer acetate 0.5 milligram (mg)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Copaxone 20 mg
Intervention Description
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Intervention Type
Drug
Intervention Name(s)
Plovamer acetate 3 mg
Intervention Description
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Intervention Type
Drug
Intervention Name(s)
Plovamer acetate 10 mg
Intervention Description
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Intervention Type
Drug
Intervention Name(s)
Plovamer acetate 20 mg
Intervention Description
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Primary Outcome Measure Information:
Title
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Description
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Time Frame
Baseline , Week 12, 24, 28, 32, 36, 40
Secondary Outcome Measure Information:
Title
Mean Annualized Relapse Rate (ARR)
Description
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).
Time Frame
Baseline up to Week 40
Title
Percentage of Subjects Remaining Relapse-Free
Description
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.
Time Frame
Baseline up to Week 40
Title
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Description
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Time Frame
Weeks 12, 24, 28, 32, 36, 40
Title
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Description
New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.
Time Frame
Weeks 12, 24, 28, 32, 36,40
Title
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Description
New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.
Time Frame
Weeks 12, 24, 28, 32, 36, 40
Title
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Description
Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.
Time Frame
Baseline, Weeks 12, 24, 28, 32, 36, 40
Title
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Description
Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.
Time Frame
Baseline, Weeks 12, 24, 28, 32, 36, 40
Title
Time to First Relapse
Description
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.
Time Frame
Baseline up to Week 40
Title
Mean Change From Baseline in Brain Volume Per Subject
Description
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Time Frame
Baseline, Weeks 24, 28, 32, 36, 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Research site
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Research site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Research site
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Research site
City
Dover
State/Province
Delaware
ZIP/Postal Code
19901
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Research site
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Research site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Research site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Research site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Research site
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Research site
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Research site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Research site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Research site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Research site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
97205
Country
United States
Facility Name
Research site
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Research site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research site
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Research site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Research site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Research site
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Research site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6010
Country
United States
Facility Name
Research site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Research site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Research site
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Research site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Research Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Research site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Research site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Research site
City
Dupnitsa
Country
Bulgaria
Facility Name
Research site
City
Sofia
Country
Bulgaria
Facility Name
Research site
City
Osijek
Country
Croatia
Facility Name
Research site
City
Varazdin
Country
Croatia
Facility Name
Research site
City
Zagreb
Country
Croatia
Facility Name
Research site
City
Brno
Country
Czech Republic
Facility Name
Research site
City
Havirov
Country
Czech Republic
Facility Name
Research site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research site
City
Jihlava
Country
Czech Republic
Facility Name
Research site
City
Olomouc
Country
Czech Republic
Facility Name
Research site
City
Praha
Country
Czech Republic
Facility Name
Research site
City
Kuopio
Country
Finland
Facility Name
Research site
City
Oulu
Country
Finland
Facility Name
Research site
City
Turku
Country
Finland
Facility Name
Research site
City
Athens
Country
Greece
Facility Name
Research site
City
Thessaloniki
Country
Greece
Facility Name
Research site
City
Budapest
Country
Hungary
Facility Name
Research site
City
Debrecen
Country
Hungary
Facility Name
Research site
City
Esztergom
Country
Hungary
Facility Name
Research site
City
Miskolc
Country
Hungary
Facility Name
Research site
City
Castelfiorentino
Country
Italy
Facility Name
Research site
City
Catania
Country
Italy
Facility Name
Research site
City
Cefalù
Country
Italy
Facility Name
Research site
City
Milano
Country
Italy
Facility Name
Research site
City
Modena
Country
Italy
Facility Name
Research site
City
Montichiari
Country
Italy
Facility Name
Research site
City
Parma
Country
Italy
Facility Name
Research site
City
Roma
Country
Italy
Facility Name
Research site
City
Cuautitlan Izcalli
Country
Mexico
Facility Name
Research site
City
Leon
Country
Mexico
Facility Name
Research site
City
Mexico City
Country
Mexico
Facility Name
Research site
City
Mexico
Country
Mexico
Facility Name
Research site
City
Monterrey
Country
Mexico
Facility Name
Research site
City
Morelia
Country
Mexico
Facility Name
Research site
City
Tlalnepantla
Country
Mexico
Facility Name
Research site
City
Gdansk
Country
Poland
Facility Name
Research site
City
Katowice
Country
Poland
Facility Name
Research site
City
Lodz
Country
Poland
Facility Name
Research site
City
Olsztyn
Country
Poland
Facility Name
Research site
City
Poznan
Country
Poland
Facility Name
Research site
City
Rzeszow
Country
Poland
Facility Name
Research site
City
Warsaw
Country
Poland
Facility Name
Research site
City
Warszawa
Country
Poland
Facility Name
Research site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research site
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Research site
City
Kursk
Country
Russian Federation
Facility Name
Research site
City
Moscow
Country
Russian Federation
Facility Name
Research site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Research site
City
Saransk
Country
Russian Federation
Facility Name
Research site
City
St Petersburg
Country
Russian Federation
Facility Name
Research site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research site
City
Ufa
Country
Russian Federation
Facility Name
Research site
City
Belgrade
Country
Serbia
Facility Name
Research site
City
Kragujevac
Country
Serbia
Facility Name
Research site
City
Nis
Country
Serbia
Facility Name
Research site
City
Cape Town
Country
South Africa
Facility Name
Research site
City
Durban
Country
South Africa
Facility Name
Research site
City
Pretoria
Country
South Africa
Facility Name
Research site
City
Aranjuez
Country
Spain
Facility Name
Research site
City
Córdoba
Country
Spain
Facility Name
Research site
City
Madrid
Country
Spain
Facility Name
Research site
City
Mostoles
Country
Spain
Facility Name
Research site
City
Santander
Country
Spain
Facility Name
Research site
City
Zaragoza
Country
Spain
Facility Name
Research site
City
Diyarbakir
Country
Turkey
Facility Name
Research site
City
Edirne
Country
Turkey
Facility Name
Research site
City
Istanbul
Country
Turkey
Facility Name
Research site
City
Kocaeli
Country
Turkey
Facility Name
Research site
City
Mersin
Country
Turkey
Facility Name
Research site
City
Samsun
Country
Turkey
Facility Name
Research site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research site
City
Kyiv
Country
Ukraine
Facility Name
Research site
City
Lutsk
Country
Ukraine
Facility Name
Research site
City
Simferopol
Country
Ukraine
Facility Name
Research site
City
Vinnytsia
Country
Ukraine
Facility Name
Research site
City
Zaporizhzhia
Country
Ukraine
Facility Name
Research site
City
Exeter
Country
United Kingdom
Facility Name
Research site
City
Hull
Country
United Kingdom
Facility Name
Research site
City
Sheffield
Country
United Kingdom
Facility Name
Research site
City
Southampton
Country
United Kingdom
Facility Name
Research site
City
Stoke on Trent
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
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