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

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ClinicalTrials.gov Identifier: NCT01963611
Recruitment Status : Terminated (Study was terminated based on sponsor discretion.)
First Posted : October 16, 2013
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: Plovamer acetate 0.5 milligram (mg)
Drug: Copaxone 20 mg
Drug: Plovamer acetate 3 mg
Drug: Plovamer acetate 10 mg
Drug: Plovamer acetate 20 mg
Enrollment 255
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Period Title: Overall Study
Started 51 49 52 52 51
Safety Analysis Set 51 49 52 52 50
Completed 0 0 0 0 0
Not Completed 51 49 52 52 51
Reason Not Completed
Adverse Event             1             1             3             4             3
Protocol Violation             0             0             0             1             0
Lack of Efficacy             0             0             0             1             0
Withdrawal by Subject             3             2             1             1             3
Other             47             46             48             45             45
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 51 49 52 52 50 254
Hide Baseline Analysis Population Description
Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 49 participants 52 participants 52 participants 50 participants 254 participants
39.2  (10.73) 40.7  (9.54) 41.1  (10.83) 40.4  (9.53) 41.8  (11.61) 40.6  (10.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 52 participants 52 participants 50 participants 254 participants
Female
38
  74.5%
37
  75.5%
39
  75.0%
37
  71.2%
26
  52.0%
177
  69.7%
Male
13
  25.5%
12
  24.5%
13
  25.0%
15
  28.8%
24
  48.0%
77
  30.3%
1.Primary Outcome
Title Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: lesions per subjects per scan
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 [1]   (NA) NA [2]   (NA) 1.0  (1.41) 1.3  (2.31) 7.3  (12.70)
Week 40: (n=1,0,1,1,1) 0.0 [1]   (NA) NA [2]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA) 16.0 [1]   (NA)
[1]
Standard deviation was not reported as number of subject analyzed was 1.
[2]
Data was not reported as there was no subject.
2.Secondary Outcome
Title Mean Annualized Relapse Rate (ARR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 51 49 52 52 50
Mean (Standard Deviation)
Unit of Measure: percent relapse
0.3  (0.88) 0.2  (0.62) 0.2  (0.76) 0.2  (0.88) 0.2  (0.92)
3.Secondary Outcome
Title Percentage of Subjects Remaining Relapse-Free
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 51 49 52 52 50
Measure Type: Number
Unit of Measure: percent subjects
86.3 89.8 94.2 94.2 90.0
4.Secondary Outcome
Title Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: lesions/subject/scan
Week 12: (n=44,45,43,41,44) 1.7  (3.26) 1.2  (3.54) 1.2  (2.26) 1.3  (2.99) 1.6  (4.31)
Week 24: (n=17,17,21,18,19) 1.5  (2.53) 0.9  (2.33) 1.4  (3.56) 1.0  (1.94) 0.5  (1.26)
Week 28: (n=10,11,13,12,13) 1.2  (2.15) 0.1  (0.30) 0.5  (1.13) 1.8  (3.83) 0.5  (1.33)
Week 32: (n=5,6,9,10,9) 0.8  (1.10) 0.2  (0.41) 0.4  (1.33) 1.5  (2.95) 0.6  (1.67)
Week 36: (n=1,0,2,3,3) 0.0 [1]   (NA) NA [2]   (NA) 0.5  (0.71) 1.0  (1.73) 5.7  (9.81)
Week 40: (n=1,0,1,1,1) 0.0 [1]   (NA) NA [2]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA) 16.0 [1]   (NA)
[1]
Standard deviation was not reported as number of subject analyzed was 1.
[2]
Data was not reported as there was no subject.
5.Secondary Outcome
Title Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: lesions/subject/scan
Week 12: (n=44,45,43,41,44) 4.5  (7.41) 2.6  (4.99) 2.7  (4.50) 4.1  (7.45) 4.0  (8.59)
Week 24: (n=17,17,21,18,19) 3.1  (5.61) 1.8  (3.35) 2.3  (4.91) 3.4  (6.03) 1.7  (3.45)
Week 28: (n=10,11,13,12,13) 1.3  (2.45) 0.2  (0.40) 0.8  (1.69) 2.5  (5.05) 0.8  (2.15)
Week 32: (n=5,6,9,10,9) 1.4  (2.19) 0.2  (0.41) 0.3  (0.71) 2.4  (4.12) 0.9  (2.32)
Week 36: (n=1,0,2,3,3) 0.0 [1]   (NA) NA [2]   (NA) 0.5  (0.71) 1.7  (2.89) 4.3  (7.51)
Week 40: (n=1,0,1,1,1) 0.0 [1]   (NA) NA [2]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA) 13.0 [1]   (NA)
[1]
Standard deviation was not reported as number of subject analyzed was 1.
[2]
Data was not reported as there was no subject.
6.Secondary Outcome
Title Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: lesions/subject/scan
Week 12: (n=44,45,43,41,44) 2.8  (6.48) 1.8  (3.97) 1.4  (2.21) 2.6  (5.24) 2.6  (5.13)
Week 24: (n=17,17,21,18,19) 2.0  (4.80) 0.8  (1.55) 0.8  (1.83) 1.3  (2.89) 0.8  (1.75)
Week 28: (n=10,11,13,12,13) 0.6  (1.26) 0.2  (0.60) 0.6  (1.56) 0.5  (1.00) 0.4  (1.39)
Week 32: (n=5,6,9,10,9) 2.0  (3.39) 0.2  (0.41) 0.8  (1.30) 0.7  (1.25) 0.3  (0.71)
Week 36: (n=1,0,2,3,3) 0.0 [1]   (NA) NA [2]   (NA) 0.0  (0.00) 0.7  (1.15) 1.7  (2.89)
Week 40: (n=1,0,1,1,1) 0.0 [1]   (NA) NA [2]   (NA) 0.0 [1]   (NA) 0.0 [1]   (NA) 11.0 [1]   (NA)
[1]
Standard deviation was not reported as number of subject analyzed was 1.
[2]
Data was not reported as there was no subject.
7.Secondary Outcome
Title Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: cubic millimeter (mm^3)
Baseline: (n=44,45,42,41,44) 0.182  (0.4212) 0.209  (0.6325) 0.138  (0.3577) 0.508  (1.1981) 0.264  (0.5707)
Change at Week 12: (n=44,45,42,41,44) 0.037  (0.3982) -0.007  (0.6019) 0.189  (0.8406) -0.190  (1.0389) 0.023  (0.5794)
Change at Week 24: (n=16,17,20,18,19) 0.053  (0.1705) 0.352  (1.4308) 0.060  (0.4858) -0.591  (1.4910) -0.250  (0.5393)
Change at Week 28: (n=9,11,12,12,13) 0.224  (0.2948) 0.067  (0.4640) 0.057  (0.5728) -0.796  (1.7779) -0.257  (0.6980)
Change at Week 32: (n=4,6,8,10,9) -0.085  (0.2765) -0.102  (0.2691) -0.135  (0.6305) -0.988  (1.9800) 0.031  (0.8312)
Change at Week 36: (n=0,0,1,3,3) NA [1]   (NA) NA [1]   (NA) 0.321 [2]   (NA) -1.881  (3.4679) 0.834  (2.1816)
Change at Week 40: (n=0,0,0,1,1) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 0.000 [2]   (NA) 2.180 [2]   (NA)
[1]
Data was not reported as there was no subject.
[2]
Standard deviation was not reported as number of subject analyzed was 1.
8.Secondary Outcome
Title Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 45 45 43 41 44
Mean (Standard Deviation)
Unit of Measure: cubic millimeter (mm^3)
Baseline (n=44,45,42,41,44) 12.240  (14.6956) 13.482  (19.0522) 11.364  (16.0282) 9.518  (13.2248) 11.616  (15.4960)
Change at Week 12: (n=44,45,42,41,44) 0.443  (2.2414) 0.397  (1.0399) 0.686  (2.4894) -0.200  (4.5312) 0.060  (1.3886)
Change at Week 24: (n=16,17,20,18,19) -0.179  (2.2741) 0.871  (2.7803) 0.113  (1.2011) -1.734  (6.8085) -0.907  (2.5627)
Change at Week 28: (n=9,11,12,12,13) 0.016  (3.2248) 0.858  (3.0417) 0.306  (1.1945) -2.610  (8.3108) -1.379  (3.4251)
Change at Week 32: (n=4,6,8,10,9) 0.874  (2.4859) 0.163  (1.2524) -0.106  (1.3423) -3.246  (9.3533) -1.867  (3.6432)
Change at Week 36: (n=0,0,1,3,3) NA [1]   (NA) NA [1]   (NA) 1.236 [2]   (NA) -10.324  (17.2227) -4.433  (4.6895)
Change at Week 40: (n=0,0,0,1,1) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) -29.965 [2]   (NA) -10.661 [2]   (NA)
[1]
Data was not reported as there was no subject.
[2]
Standard deviation was not reported as number of subject analyzed was 1.
9.Secondary Outcome
Title Time to First Relapse
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was not derived due to early termination of the study.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Mean Change From Baseline in Brain Volume Per Subject
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was not derived due to early termination of the study.
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to end of treatment (week 40)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Hide Arm/Group Description Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks. Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks. Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks. Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks. Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
All-Cause Mortality
Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/51 (3.92%)   0/49 (0.00%)   2/52 (3.85%)   3/52 (5.77%)   0/50 (0.00%) 
Gastrointestinal disorders           
Constipation * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Pancreatitis acute * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
General disorders           
Influenza like illness * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Immune system disorders           
Drug hypersensitivity * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Infections and infestations           
Cellulitis * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Pyelonephritis * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Urinary tract infection * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications           
Alcohol poisoning * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Psychiatric disorders           
Major depression * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Suicidal ideation * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Vascular disorders           
Venous thrombosis * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plovamer Acetate 0.5 Milligram (mg) Plovamer Acetate 3 mg Plovamer Acetate 10 mg Plovamer Acetate 20 mg Copaxone 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/51 (54.90%)   34/49 (69.39%)   38/52 (73.08%)   41/52 (78.85%)   42/50 (84.00%) 
Blood and lymphatic system disorders           
Increased tendency to bruise * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Cardiac disorders           
Hypertensive heart disease * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Palpitations * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Supraventricular tachycardia * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Ear and labyrinth disorders           
Tinnitus * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Vertigo * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Eye disorders           
Eyelid skin dryness * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Iritis * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Vision blurred * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Gastrointestinal disorders           
Nausea * 1  2/51 (3.92%)  0/49 (0.00%)  2/52 (3.85%)  2/52 (3.85%)  2/50 (4.00%) 
Constipation * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Diarrhoea * 1  0/51 (0.00%)  2/49 (4.08%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Abdominal pain lower * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Abdominal pain upper * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Melanosis coli * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Abdominal rigidity * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
General disorders           
Injection site pain * 1  8/51 (15.69%)  20/49 (40.82%)  26/52 (50.00%)  26/52 (50.00%)  28/50 (56.00%) 
Injection site erythema * 1  10/51 (19.61%)  16/49 (32.65%)  14/52 (26.92%)  19/52 (36.54%)  18/50 (36.00%) 
Injection site pruritus * 1  3/51 (5.88%)  6/49 (12.24%)  10/52 (19.23%)  4/52 (7.69%)  15/50 (30.00%) 
Injection site induration * 1  1/51 (1.96%)  2/49 (4.08%)  5/52 (9.62%)  6/52 (11.54%)  4/50 (8.00%) 
Injection site oedema * 1  1/51 (1.96%)  1/49 (2.04%)  2/52 (3.85%)  2/52 (3.85%)  2/50 (4.00%) 
Injection site bruising * 1  3/51 (5.88%)  1/49 (2.04%)  0/52 (0.00%)  1/52 (1.92%)  3/50 (6.00%) 
Influenza like illness * 1  1/51 (1.96%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  1/50 (2.00%) 
Injection site haematoma * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  2/52 (3.85%)  4/50 (8.00%) 
Injection site laceration * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  1/52 (1.92%)  0/50 (0.00%) 
Injection site nodule * 1  0/51 (0.00%)  1/49 (2.04%)  2/52 (3.85%)  0/52 (0.00%)  0/50 (0.00%) 
Injection site rash * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  0/50 (0.00%) 
Pyrexia * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  2/52 (3.85%)  0/50 (0.00%) 
Asthenia * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Chest discomfort * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Chills * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Fatigue * 1  1/51 (1.96%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Injection site haemorrhage * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  2/52 (3.85%)  0/50 (0.00%) 
Injection site paraesthesia * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Injection site swelling * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  1/50 (2.00%) 
Oedema peripheral * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Chest pain * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Inflammation * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Injection site cyst * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Injection site mass * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Peripheral swelling * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Cyst * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Hyperthermia * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Injection site discolouration * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Injection site granuloma * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Pain * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Hepatobiliary disorders           
Cholecystitis acute * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Cholelithiasis * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Hepatomegaly * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Infections and infestations           
Nasopharyngitis * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  6/52 (11.54%)  0/50 (0.00%) 
Upper respiratory tract infection * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  3/52 (5.77%)  4/50 (8.00%) 
Urinary tract infection * 1  2/51 (3.92%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  1/50 (2.00%) 
Bronchitis * 1  1/51 (1.96%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Cystitis * 1  0/51 (0.00%)  1/49 (2.04%)  2/52 (3.85%)  0/52 (0.00%)  0/50 (0.00%) 
Gastroenteritis * 1  0/51 (0.00%)  2/49 (4.08%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Tonsillitis * 1  0/51 (0.00%)  0/49 (0.00%)  2/52 (3.85%)  1/52 (1.92%)  0/50 (0.00%) 
Conjunctivitis * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Erythema migrans * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  2/52 (3.85%)  0/50 (0.00%) 
Herpes simplex * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Chronic tonsillitis * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Ear infection * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Gastroenteritis viral * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Herpes zoster * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Influenza * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Laryngitis * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Pneumonia * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Tracheitis * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Urethritis * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Sinusitis * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Injury, poisoning and procedural complications           
Head injury * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Ligament sprain * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Sunburn * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Wound * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Arthropod sting * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Investigations           
Alanine aminotransferase increased * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  2/52 (3.85%)  0/50 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  2/50 (4.00%) 
Aspartate aminotransferase increased * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Electrocardiogram PR shortened * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Liver function test abnormal * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Metabolism and nutrition disorders           
Hypertriglyceridaemia * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  3/51 (5.88%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Pain in extremity * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  0/50 (0.00%) 
Muscular weakness * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Neck pain * 1  1/51 (1.96%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Joint stiffness * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Muscle spasms * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Myalgia * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Myokymia * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Osteoarthritis * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Fibroadenoma of breast * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Skin papilloma * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Nervous system disorders           
Headache * 1  4/51 (7.84%)  0/49 (0.00%)  1/52 (1.92%)  4/52 (7.69%)  0/50 (0.00%) 
Dizziness * 1  0/51 (0.00%)  1/49 (2.04%)  1/52 (1.92%)  2/52 (3.85%)  1/50 (2.00%) 
Carpal tunnel syndrome * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Essential tremor * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Muscle spasticity * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Paraesthesia * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Radicular pain * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Restless legs syndrome * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Loss of consciousness * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Perineurial cyst * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Peripheral sensory neuropathy * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Psychiatric disorders           
Depression * 1  1/51 (1.96%)  1/49 (2.04%)  2/52 (3.85%)  0/52 (0.00%)  0/50 (0.00%) 
Depressive symptom * 1  0/51 (0.00%)  2/49 (4.08%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Anxiety * 1  1/51 (1.96%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Panic attack * 1  0/51 (0.00%)  2/49 (4.08%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Adjustment disorder * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Affective disorder * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Depressed mood * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  1/50 (2.00%) 
Emotional disorder * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Insomnia * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Mood altered * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Nightmare * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Renal and urinary disorders           
Urinary hesitation * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Urinary incontinence * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Reproductive system and breast disorders           
Epididymal cyst * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Erectile dysfunction * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Benign prostatic hyperplasia * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders           
Bronchospasm * 1  0/51 (0.00%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Cough * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Dysphonia * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Dyspnoea * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia * 1  1/51 (1.96%)  0/49 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/50 (0.00%) 
Acne * 1  1/51 (1.96%)  0/49 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Ecchymosis * 1  0/51 (0.00%)  0/49 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
Erythema * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  0/52 (0.00%)  0/50 (0.00%) 
Vascular disorders           
Hypertension * 1  0/51 (0.00%)  1/49 (2.04%)  0/52 (0.00%)  1/52 (1.92%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Based on Sponsor decision to discontinue the clinical development program of plovamer acetate therapy for multiple sclerosis the trial was prematurely terminated
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01963611     History of Changes
Other Study ID Numbers: EMR200575-001
2013-002283-25 ( EudraCT Number )
First Submitted: October 11, 2013
First Posted: October 16, 2013
Results First Submitted: April 5, 2016
Results First Posted: May 11, 2016
Last Update Posted: May 11, 2016