Trial · NCT01963611
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
NCT01963611, Phase 2, Terminated, EMD Serono; results first posted 2016-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1). Trials, record NCT01963611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01963611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
- NCT number
- NCT01963611
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 255 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Plovamer acetate 0.5 milligram (mg), Copaxone 20 mg, Plovamer acetate 3 mg, Plovamer acetate 10 mg, Plovamer acetate 20 mg
- First posted
- 2013-10-16
- Last updated
- 2016-05-11
- Other registries' IDs
- eudract:2013-002283-25
- Results first posted
- 2016-05-11
- Limitations and caveats
- Based on Sponsor decision to discontinue the clinical development program of plovamer acetate therapy for multiple sclerosis the trial was prematurely terminated
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | 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. |
| Secondary | Mean Annualized Relapse Rate (ARR) | Baseline up to Week 40 | 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). |
| Secondary | Percentage of Subjects Remaining Relapse-Free | Baseline up to Week 40 | 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. |
| Secondary | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans. |
| Secondary | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36,40 | New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans. |
| Secondary | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs. |
| Secondary | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans. |
| Secondary | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan. |
| Secondary | Time to First Relapse | Baseline up to Week 40 | 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. |
| Secondary | Mean Change From Baseline in Brain Volume Per Subject | Baseline, Weeks 24, 28, 32, 36, 40 | Change from baseline in brain volume per subject was calculated using 5 series MRI scan. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline , Week 12, 24, 28, 32, 36, 40 | 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. | lesions per subjects per scan | MEAN |
| SECONDARY | Mean Annualized Relapse Rate (ARR) | Baseline up to Week 40 | Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP). | percent relapse | MEAN |
| SECONDARY | Percentage of Subjects Remaining Relapse-Free | Baseline up to Week 40 | Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP). | percent subjects | NUMBER |
| SECONDARY | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | 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. | lesions/subject/scan | MEAN |
| SECONDARY | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36,40 | 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. | lesions/subject/scan | MEAN |
| SECONDARY | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | 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. | lesions/subject/scan | MEAN |
| SECONDARY | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | 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. | cubic millimeter (mm^3) | MEAN |
| SECONDARY | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | 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. | cubic millimeter (mm^3) | MEAN |
| SECONDARY | Time to First Relapse | Baseline up to Week 40 | The Outcome Measure was not derived due to early termination of the study. | ||
| SECONDARY | Mean Change From Baseline in Brain Volume Per Subject | Baseline, Weeks 24, 28, 32, 36, 40 | The Outcome Measure was not derived due to early termination of the study. |
Source ClinicalTrials.gov
Results by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 0.5 Milligram (mg) | Baseline (n=44,45,42,41,44) | 1.5 | Standard Deviation 2.93 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 3 mg | Baseline (n=44,45,42,41,44) | 1.6 | Standard Deviation 4.12 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 10 mg | Baseline (n=44,45,42,41,44) | 1.0 | Standard Deviation 2.43 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 20 mg | Baseline (n=44,45,42,41,44) | 2.3 | Standard Deviation 5.65 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Copaxone 20 mg | Baseline (n=44,45,42,41,44) | 2.5 | Standard Deviation 5.12 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 0.5 Milligram (mg) | Week 12: (n=44,45,43,41,44) | 1.7 | Standard Deviation 3.28 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 3 mg | Week 12: (n=44,45,43,41,44) | 1.3 | Standard Deviation 3.55 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 10 mg | Week 12: (n=44,45,43,41,44) | 1.2 | Standard Deviation 2.40 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Plovamer Acetate 20 mg | Week 12: (n=44,45,43,41,44) | 1.5 | Standard Deviation 3.70 | lesions per subjects per scan |
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Copaxone 20 mg | Week 12: (n=44,45,43,41,44) | 1.7 | Standard Deviation 4.51 | lesions per subjects per scan |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plovamer Acetate 0.5 Milligram (mg) | 51 | |
| Overall Study | STARTED | Plovamer Acetate 3 mg | 49 | |
| Overall Study | STARTED | Plovamer Acetate 10 mg | 52 | |
| Overall Study | STARTED | Plovamer Acetate 20 mg | 52 | |
| Overall Study | STARTED | Copaxone 20 mg | 51 | |
| Overall Study | Safety Analysis Set | Plovamer Acetate 0.5 Milligram (mg) | 51 | |
| Overall Study | Safety Analysis Set | Plovamer Acetate 3 mg | 49 | |
| Overall Study | Safety Analysis Set | Plovamer Acetate 10 mg | 52 | |
| Overall Study | Safety Analysis Set | Plovamer Acetate 20 mg | 52 | |
| Overall Study | Safety Analysis Set | Copaxone 20 mg | 50 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events690
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Plovamer Acetate 0.5 Milligram (mg) | 1 | 51 | |
| other | Nasopharyngitis | Infections and infestations | Plovamer Acetate 3 mg | 0 | 49 | |
| other | Nasopharyngitis | Infections and infestations | Plovamer Acetate 10 mg | 1 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Plovamer Acetate 20 mg | 6 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Copaxone 20 mg | 0 | 50 | |
| other | Upper respiratory tract infection | Infections and infestations | Plovamer Acetate 0.5 Milligram (mg) | 1 | 51 | |
| other | Upper respiratory tract infection | Infections and infestations | Plovamer Acetate 3 mg | 0 | 49 | |
| other | Upper respiratory tract infection | Infections and infestations | Plovamer Acetate 10 mg | 1 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | Plovamer Acetate 20 mg | 3 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | Copaxone 20 mg | 4 | 50 |
1 to 10 of 690Source ClinicalTrials.gov
See all 690 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plovamer Acetate 0.5 Milligram (mg) | ||
| Total, all-cause mortality | Plovamer Acetate 3 mg | ||
| Total, all-cause mortality | Plovamer Acetate 10 mg | ||
| Total, all-cause mortality | Plovamer Acetate 20 mg | ||
| Total, all-cause mortality | Copaxone 20 mg | ||
| Total, other adverse events | Plovamer Acetate 0.5 Milligram (mg) | 28 | 51 |
| Total, other adverse events | Plovamer Acetate 3 mg | 34 | 49 |
| Total, other adverse events | Plovamer Acetate 10 mg | 38 | 52 |
| Total, other adverse events | Plovamer Acetate 20 mg | 41 | 52 |
| Total, other adverse events | Copaxone 20 mg | 42 | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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