ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke (PLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01464307
Recruitment Status : Completed
First Posted : November 3, 2011
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-stroke Spasticity of the Lower Limb
Interventions Drug: IncobotulinumtoxinA (400 Units)
Drug: Placebo Comparator
Enrollment 290
Recruitment Details A total of 331 individuals suffering from post-stroke lower-limb spasticity were screened and 290 were included in study at 51 sites. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. For purpose of study analysis overall number of subjects enrolled is therefore considered 289.
Pre-assignment Details A total of 290 subjects were enrolled in study. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. A total of 289 subjects were enrolled in main period. All of the 269 subjects who completed the main period of the study entered the open-label extension period.
Arm/Group Title IncobotulinumtoxinA (Xeomin) 400 Units Placebo
Hide Arm/Group Description

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.

IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Period Title: Main Period
Started 144 145
Treated 144 145
Completed 129 140
Not Completed 15 5
Reason Not Completed
Death             0             1
Adverse Event             6             1
Lack of Efficacy             2             0
Withdrawal by Subject             5             2
Predefined discontinuation criteria             2             1
Period Title: Open-Label Extension Period
Started 269 0
Treated 269 0
Completed 218 0
Not Completed 51 0
Reason Not Completed
Adverse Event             15             0
Withdrawal by Subject             14             0
Lack of Efficacy             5             0
Death             1             0
Lost to Follow-up             1             0
Non-compliance             9             0
Predefined discontinuation criteria             6             0
Arm/Group Title Main Period: IncobotulinumtoxinA (Xeomin) 400 Units Main Period: Placebo Total
Hide Arm/Group Description

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Total of all reporting groups
Overall Number of Baseline Participants 144 145 289
Hide Baseline Analysis Population Description
The Safety Evaluation Set (SES) is the subset of all subjects who were exposed to Investigational product (IP) in the main period at least once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants 145 participants 289 participants
57.3  (11.2) 57.0  (13.0) 57.2  (12.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 145 participants 289 participants
Female
40
  27.8%
55
  37.9%
95
  32.9%
Male
104
  72.2%
90
  62.1%
194
  67.1%
1.Primary Outcome
Title Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4
Hide Description The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.
Arm/Group Title IncobotulinumtoxinA (Xeomin) 400 Units Placebo
Hide Arm/Group Description:

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.8  (0.7) 2.8  (0.7)
Change at Week 4 -0.4  (0.7) -0.4  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IncobotulinumtoxinA (Xeomin) 400 Units, Placebo
Comments The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.777
Comments [Not Specified]
Method Mixed-Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
Hide Description A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.
Arm/Group Title IncobotulinumtoxinA (Xeomin) 400 Units Placebo
Hide Arm/Group Description:

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Overall Number of Participants Analyzed 144 145
Measure Type: Number
Unit of Measure: Percentage of Participants
Very good 3.5 4.8
Good 28.5 22.8
Moderate 22.2 26.9
Poor 45.8 45.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IncobotulinumtoxinA (Xeomin) 400 Units, Placebo
Comments The statistical analysis provided was for all categories of this outcome measure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments worst-case analysis.
Method Wilcoxon's Rank-Sum Test
Comments [Not Specified]
3.Secondary Outcome
Title Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)
Hide Description Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time Frame Week 4, 8, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, “N”(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point respectively.
Arm/Group Title IncobotulinumtoxinA (Xeomin) 400 Units Placebo
Hide Arm/Group Description:

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Overall Number of Participants Analyzed 142 144
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 (n=142, 144) 37.3 35.4
Week 8 (n=140, 142) 39.3 33.8
Week 12 (n=135, 141) 20 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IncobotulinumtoxinA (Xeomin) 400 Units, Placebo
Comments Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments observed cases analysis.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.63 to 1.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IncobotulinumtoxinA (Xeomin) 400 Units, Placebo
Comments Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments observed cases analysis.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.73 to 2.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IncobotulinumtoxinA (Xeomin) 400 Units, Placebo
Comments Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments observed cases analysis.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.59 to 2.21
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits
Hide Description The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, ‘n’ specifies those subjects who were evaluated for this outcome measure at given time point.
Time Frame Baseline, Week 4, 8, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.
Arm/Group Title IncobotulinumtoxinA (Xeomin) 400 Units Placebo
Hide Arm/Group Description:

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Overall Number of Participants Analyzed 144 145
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=144, 145) 2.8  (0.7) 2.8  (0.7)
Week 4 (n= 142, 144) 2.4  (0.9) 2.4  (0.8)
Week 8 (n=140, 142) 2.4  (0.9) 2.5  (0.7)
Week 12 (n= 135, 141) 2.7  (0.8) 2.7  (0.7)
Time Frame From time point of first injection until 120 +/- 7 days after last administration of injection
Adverse Event Reporting Description The investigator asked the subject for adverse events systematically at each visit.
 
Arm/Group Title Main Period: IncobotulinumtoxinA (Xeomin) 400 Units Main Period: Placebo Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units
Hide Arm/Group Description

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.

All-Cause Mortality
Main Period: IncobotulinumtoxinA (Xeomin) 400 Units Main Period: Placebo Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Main Period: IncobotulinumtoxinA (Xeomin) 400 Units Main Period: Placebo Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/144 (4.17%)      5/145 (3.45%)      22/269 (8.18%)    
Blood and lymphatic system disorders       
Haemolytic anaemia  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Cardiac disorders       
Acute myocardial infarction  1  1/144 (0.69%)  0/145 (0.00%)  1/269 (0.37%) 
Cardiac arrest  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
General disorders       
General physical health deterioration  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Hepatobiliary disorders       
Jaundice cholestatic  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Cholelithiasis  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Infections and infestations       
Pneumonia  1  0/144 (0.00%)  1/145 (0.69%)  0/269 (0.00%) 
Urinary tract infection  1  0/144 (0.00%)  1/145 (0.69%)  1/269 (0.37%) 
Staphylococcal bacteraemia  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Injury, poisoning and procedural complications       
Fall  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Fractured sacrum  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Hip fracture  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Spinal fracture  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Patella fracture  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Face injury  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Head injury  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Humerus fracture  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Upper-limb fracture  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Metabolism and nutrition disorders       
Dehydration  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Malnutrition  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Electrolyte imbalance  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Musculoskeletal and connective tissue disorders       
Mobility decreased  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Musculoskeletal pain  1  0/144 (0.00%)  1/145 (0.69%)  0/269 (0.00%) 
Foot deformity  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic neoplasm  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Adenocarcinoma of colon  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Prostate cancer  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Uterine leiomyoma  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Desmoid tumour  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Nervous system disorders       
Epilepsy  1  1/144 (0.69%)  0/145 (0.00%)  2/269 (0.74%) 
Intracranial haematoma  1  0/144 (0.00%)  1/145 (0.69%)  0/269 (0.00%) 
Cerebral ischaemia  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Cerebrovascular accident  1  1/144 (0.69%)  0/145 (0.00%)  1/269 (0.37%) 
Ischaemic stroke  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Psychiatric disorders       
Personality disorder  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/144 (0.00%)  1/145 (0.69%)  0/269 (0.00%) 
Acute kidney injury  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Reproductive system and breast disorders       
Uterine polyp  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/144 (0.00%)  1/145 (0.69%)  1/269 (0.37%) 
Acute respiratory failure  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Social circumstances       
Immobile  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Surgical and medical procedures       
Cranioplasty  1  1/144 (0.69%)  0/145 (0.00%)  0/269 (0.00%) 
Medical induction of coma  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Skin lesion excision  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Tracheostomy  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Limb operation  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Rehabilitation therapy  1  0/144 (0.00%)  0/145 (0.00%)  1/269 (0.37%) 
Indicates events were collected by 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 2%
Main Period: IncobotulinumtoxinA (Xeomin) 400 Units Main Period: Placebo Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/144 (9.03%)      13/145 (8.97%)      31/269 (11.52%)    
Eye disorders       
Vision blurred  1  3/144 (2.08%)  4 0/145 (0.00%)  0 1/269 (0.37%)  2
General disorders       
Oedema peripheral  1  0/144 (0.00%)  0 3/145 (2.07%)  3 3/269 (1.12%)  3
Infections and infestations       
Nasopharyngitis  1  3/144 (2.08%)  3 1/145 (0.69%)  1 4/269 (1.49%)  5
Injury, poisoning and procedural complications       
Fall  1  0/144 (0.00%)  0 2/145 (1.38%)  3 11/269 (4.09%)  12
Investigations       
γ-glutamyltransferase increased  1  0/144 (0.00%)  0 0/145 (0.00%)  0 7/269 (2.60%)  7
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  7/144 (4.86%)  8 7/145 (4.83%)  9 10/269 (3.72%)  10
Back pain  1  0/144 (0.00%)  0 0/145 (0.00%)  0 6/269 (2.23%)  6
Nervous system disorders       
Headache  1  1/144 (0.69%)  1 3/145 (2.07%)  4 2/269 (0.74%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the Investigator will consider these doubts in the publication as long as the scientific neutrality is not affected.
Results Point of Contact
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
Phone: +49 69 1503 1
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01464307     History of Changes
Other Study ID Numbers: MRZ 60201/SP/3002
2010-024579-23 ( EudraCT Number )
First Submitted: November 1, 2011
First Posted: November 3, 2011
Results First Submitted: July 26, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016