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Trial record 16 of 25 for:    Injuries | Spinal Cord Injuries | ( Map: Minnesota, United States )

Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01683838
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : February 5, 2014
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Spinal Cord Injury
Muscle Spasticity
Interventions Drug: Fampridine-SR
Drug: Placebo
Enrollment 204
Recruitment Details The randomization schedule was created prior to the start of the study, and was blocked and stratified by site and by concomitant anti-spasmodic medication status to ensure treatment balance between patients who were treated with anti-spasmodic medications upon entry into the study and those who were not.
Pre-assignment Details Investigational drug assignments were communicated through an Interactive Voice Response System (IVRS).
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description Fampridine-SR : 25mg bid (twice daily) Placebo : Placebo
Period Title: Overall Study
Started 104 100
Intent to Treat (ITT) Population 103 100
Safety Population 103 100
Efficacy Population 89 93
Completed 78 88
Not Completed 26 12
Reason Not Completed
Adverse Event             12             2
Protocol Violation             3             1
Withdrawal by Subject             6             5
Lost to Follow-up             1             1
not specified             4             3
Arm/Group Title Fampridine-SR 50mg/Day Placebo Total
Hide Arm/Group Description Fampridine-SR : 25mg bid (twice daily) Placebo : Placebo Total of all reporting groups
Overall Number of Baseline Participants 103 100 203
Hide Baseline Analysis Population Description
104 patients randomized to Fampridine-SR 50mg/day 100 patients randomized to Placebo. Total patients randomized = 204. Overall, 203 (99.5%) patients were included in the ITT population, 182 (89.2%) in the Efficacy population and 203 (99.5%) in the Safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 100 participants 203 participants
41.3  (11.79) 40.5  (12.25) 40.9  (12.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 203 participants
Female
17
  16.5%
14
  14.0%
31
  15.3%
Male
86
  83.5%
86
  86.0%
172
  84.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 203 participants
Caucasian 92 87 179
Black or African American 8 10 18
Asian/Pacific Islander 1 0 1
Other 2 3 5
1.Primary Outcome
Title Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Hide Description

The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:

1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.

The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.

Time Frame Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 102 98
Mean (Standard Error)
Unit of Measure: units on a scale
-0.28  (0.046) -0.16  (0.047)
2.Primary Outcome
Title Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
Hide Description

The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.

The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.

Time Frame Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 102 98
Mean (Standard Error)
Unit of Measure: units on a scale
-0.0  (0.07) 0.1  (0.08)
3.Secondary Outcome
Title Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
Hide Description

The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.

The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.

On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores.

Time Frame Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 102 98
Mean (Standard Error)
Unit of Measure: units on a scale
Arm Spasm Frequency -0.13  (0.051) 0.02  (0.053)
Leg Spasm Frequency -0.12  (0.051) -0.10  (0.052)
Arm Spasm Severity -0.09  (0.034) -0.02  (0.035)
Leg Spasm Severity -0.14  (0.040) -0.07  (0.041)
4.Secondary Outcome
Title Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores
Hide Description The supervising clinician rated the patient’s neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician’s overall impression of the patient’s neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.
Time Frame Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 102 98
Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.06) -0.2  (0.06)
5.Secondary Outcome
Title Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
Hide Description Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.
Time Frame Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 87 92
Mean (Standard Error)
Unit of Measure: units on a scale
0.4  (0.51) 0.7  (0.49)
6.Secondary Outcome
Title Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
Hide Description

Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.

Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement.

Time Frame Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 65 77
Mean (Standard Error)
Unit of Measure: units on a scale
EF (Fampridine-SR Number (N) =65, Placebo N=77) 0.8  (1.09) 1.6  (1.01)
OF (Fampridine-SR N=64, Placebo N=76) 0.3  (0.36) 0.0  (0.33)
SD (Fampridine-SR N=64, Placebo N=75) -0.0  (0.23) 0.0  (0.21)
IS (Fampridine-SR N=64, N=76) 0.4  (0.55) 0.4  (0.50)
OS (Fampridine-SR N=51, Placebo N=66) 0.4  (0.27) 0.3  (0.24)
7.Secondary Outcome
Title Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
Hide Description

The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).

A positive change signifies improvement.

Time Frame Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 14 13
Mean (Standard Error)
Unit of Measure: units on a scale
Desire 0.7  (0.26) 0.2  (0.28)
Arousal 0.6  (0.37) 0.2  (0.40)
Lubrication 0.7  (0.45) -0.2  (0.48)
Orgasm 0.2  (0.18) 0.4  (0.19)
Satisfaction (Fampridine-SR N=13, Placebo N=12) 0.4  (0.25) 0.3  (0.26)
Pain 0.7  (0.47) -0.1  (0.50)
8.Secondary Outcome
Title Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
Hide Description

Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.

A negative change in patient bladder/bowel function diary score signifies improvement.

Time Frame Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 103 99
Mean (Standard Error)
Unit of Measure: episodes
Number of Accidental Urination or Leakage -0.2  (0.20) -0.2  (0.21)
Number of Bowel Movements 0.1  (0.03) -0.0  (0.03)
9.Secondary Outcome
Title Adjusted Mean Change in Subject Bowel Function Diary Scores
Hide Description

Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.

A negative change in patient bowel function diary score signifies improvement.

Time Frame Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description:
Fampridine-SR : 25mg bid (twice daily)
Placebo : Placebo
Overall Number of Participants Analyzed 103 99
Mean (Standard Error)
Unit of Measure: minutes
-0.7  (0.90) 0.3  (0.93)
Time Frame Treatment-emergent adverse events (TEAE) include AEs with date of onset (or worsening) on or after the start of treatment and no more than 14 days after the last dose of investigational drug.
Adverse Event Reporting Description Adverse events were recorded at every study visit. Results are presented for the Safety population defined as all randomized patients who received at least one dose of study treatment.
 
Arm/Group Title Fampridine-SR 50mg/Day Placebo
Hide Arm/Group Description Fampridine-SR : 25mg bid (twice daily) Placebo : Placebo
All-Cause Mortality
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/103 (7.77%)      9/100 (9.00%)    
Blood and lymphatic system disorders     
Sepsis  0/103 (0.00%)  0 1/100 (1.00%)  1
Cardiac disorders     
Atrial Fibrillation  1/103 (0.97%)  1 0/100 (0.00%)  0
Bradycardia  1/103 (0.97%)  1 0/100 (0.00%)  0
Coronary Artery Disorder  0/103 (0.00%)  0 1/100 (1.00%)  1
Myocardial Infarct  1/103 (0.97%)  1 0/100 (0.00%)  0
Eye disorders     
Amblyopia  0/103 (0.00%)  0 1/100 (1.00%)  1
Gastrointestinal disorders     
Intestinal Obstruction  1/103 (0.97%)  1 0/100 (0.00%)  0
Infections and infestations     
Cellulitis  1/103 (0.97%)  1 1/100 (1.00%)  1
Hypothermia  1/103 (0.97%)  1 0/100 (0.00%)  0
Pneumonia  1/103 (0.97%)  1 0/100 (0.00%)  0
Urinary Tract Infection  1/103 (0.97%)  1 0/100 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental Injury  0/103 (0.00%)  0 1/100 (1.00%)  2
Musculoskeletal and connective tissue disorders     
Pathological Fracture  1/103 (0.97%)  1 1/100 (1.00%)  1
Tendon Disorder  0/103 (0.00%)  0 1/100 (1.00%)  1
Nervous system disorders     
Headache  1/103 (0.97%)  1 0/100 (0.00%)  0
Dysautonomia  1/103 (0.97%)  1 3/100 (3.00%)  3
Neuropathy  0/103 (0.00%)  0 1/100 (1.00%)  1
Paresthesia  0/103 (0.00%)  0 1/100 (1.00%)  1
Somnolence  1/103 (0.97%)  1 0/100 (0.00%)  0
Speech Disorder  1/103 (0.97%)  1 0/100 (0.00%)  0
Psychiatric disorders     
Overdose  0/103 (0.00%)  0 1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis  0/103 (0.00%)  0 1/100 (1.00%)  1
Skin and subcutaneous tissue disorders     
Skin Ulcer  1/103 (0.97%)  1 0/100 (0.00%)  0
Vascular disorders     
Hemorrhage  1/103 (0.97%)  1 0/100 (0.00%)  0
Hypertension  0/103 (0.00%)  0 1/100 (1.00%)  1
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fampridine-SR 50mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/103 (23.30%)      17/100 (17.00%)    
Blood and lymphatic system disorders     
Leukocvtosis  3/103 (2.91%)  3 0/100 (0.00%)  0
Cardiac disorders     
Dyspnea  3/103 (2.91%)  4 1/100 (1.00%)  1
Eye disorders     
Amblyopia  2/103 (1.94%)  2 2/100 (2.00%)  2
Gastrointestinal disorders     
Abdominal Pain  10/103 (9.71%)  11 5/100 (5.00%)  5
Nausea  9/103 (8.74%)  9 6/100 (6.00%)  6
Dyspepsia  5/103 (4.85%)  8 5/100 (5.00%)  10
Gastritis  3/103 (2.91%)  7 1/100 (1.00%)  1
Gastroenteritis  3/103 (2.91%)  3 2/100 (2.00%)  2
Diarrhea  2/103 (1.94%)  2 7/100 (7.00%)  9
Flatulence  0/103 (0.00%)  0 2/100 (2.00%)  2
General disorders     
Pain  19/103 (18.45%)  23 14/100 (14.00%)  15
Peripheral Edema  7/103 (6.80%)  8 9/100 (9.00%)  10
Fever  6/103 (5.83%)  9 5/100 (5.00%)  6
Chills  1/103 (0.97%)  1 2/100 (2.00%)  2
Infections and infestations     
Urinary Tract Infection  22/103 (21.36%)  33 15/100 (15.00%)  22
Infection  11/103 (10.68%)  12 15/100 (15.00%)  15
Flu Syndrome  5/103 (4.85%)  5 0/100 (0.00%)  0
Rhinitis  4/103 (3.88%)  5 4/100 (4.00%)  4
Fungal Dermatitis  2/103 (1.94%)  2 2/100 (2.00%)  2
Injury, poisoning and procedural complications     
Accidental Injury  9/103 (8.74%)  10 16/100 (16.00%)  22
Metabolism and nutrition disorders     
Anorexia  3/103 (2.91%)  3 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  10/103 (9.71%)  16 3/100 (3.00%)  6
Arthralgia  4/103 (3.88%)  4 3/100 (3.00%)  3
Asthenia  3/103 (2.91%)  3 6/100 (6.00%)  8
Neck Pain  3/103 (2.91%)  3 1/100 (1.00%)  1
Neck Rigidity  3/103 (2.91%)  3 2/100 (2.00%)  2
Myalgia  3/103 (2.91%)  3 3/100 (3.00%)  3
Nervous system disorders     
Paresthesia  18/103 (17.48%)  25 9/100 (9.00%)  11
Headache  15/103 (14.56%)  20 8/100 (8.00%)  11
Migraine  5/103 (4.85%)  7 1/100 (1.00%)  1
Somnolence  4/103 (3.88%)  4 1/100 (1.00%)  1
Dysautonomia  3/103 (2.91%)  3 5/100 (5.00%)  5
Neuropathy  2/103 (1.94%)  2 2/100 (2.00%)  2
Psychiatric disorders     
Hypertonia  24/103 (23.30%)  32 17/100 (17.00%)  21
Insomnia  16/103 (15.53%)  17 6/100 (6.00%)  8
Anxiety  5/103 (4.85%)  5 1/100 (1.00%)  1
Nervousness  5/103 (4.85%)  6 2/100 (2.00%)  2
Abnormal Dreams  3/103 (2.91%)  3 0/100 (0.00%)  0
Depression  3/103 (2.91%)  3 3/100 (3.00%)  3
Renal and urinary disorders     
Constipation  19/103 (18.45%)  23 10/100 (10.00%)  12
Urinary Frequency  4/103 (3.88%)  4 4/100 (4.00%)  5
Urinary Incontinence  4/103 (3.88%)  4 4/100 (4.00%)  4
Cystitis  3/103 (2.91%)  4 2/100 (2.00%)  2
Hematuria  3/103 (2.91%)  3 3/100 (3.00%)  6
Urine Abnormality  3/103 (2.91%)  3 2/100 (2.00%)  2
Dysuria  1/103 (0.97%)  1 2/100 (2.00%)  2
Reproductive system and breast disorders     
Metrorrhagia  0/103 (0.00%)  0 2/100 (2.00%)  2
Respiratory, thoracic and mediastinal disorders     
Pharyngitis  6/103 (5.83%)  6 6/100 (6.00%)  6
Cough Increased  5/103 (4.85%)  5 3/100 (3.00%)  3
Sinusitis  2/103 (1.94%)  3 2/100 (2.00%)  2
Skin and subcutaneous tissue disorders     
Rash  5/103 (4.85%)  6 7/100 (7.00%)  7
Skin Ulcer  5/103 (4.85%)  5 5/100 (5.00%)  6
Sweating  5/103 (4.85%)  5 3/100 (3.00%)  3
Photosensitivity Reaction  2/103 (1.94%)  2 2/100 (2.00%)  2
Maculopapular Rash  0/103 (0.00%)  0 2/100 (2.00%)  2
Vascular disorders     
Dizziness  12/103 (11.65%)  12 1/100 (1.00%)  1
Ecchymosis  5/103 (4.85%)  5 1/100 (1.00%)  1
Vasodilatation  3/103 (2.91%)  4 1/100 (1.00%)  1
Hypertension  0/103 (0.00%)  0 3/100 (3.00%)  4
1
Term from vocabulary, COSTART
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.
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Scientific Officer
Organization: Acorda Therapeutics, Inc.
Phone: 914-347-4300 ext 5102
EMail: ablight@acorda.com
Layout table for additonal information
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01683838     History of Changes
Other Study ID Numbers: SCI-F302
First Submitted: August 24, 2012
First Posted: September 12, 2012
Results First Submitted: July 23, 2013
Results First Posted: February 5, 2014
Last Update Posted: August 25, 2017