Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Ataluren (PTC124™) in Cystic Fibrosis

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: NCT00803205
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
PTC Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: Ataluren
Drug: Placebo
Enrollment 238
Recruitment Details A total of 299 male and female participants with nonsense-mutation-mediated cystic fibrosis (nmCF) aged ≥6 years signed the informed consent form and were screened for eligibility, of which 61 did not meet entry criteria to participate in the study.
Pre-assignment Details A total of 238 participants were randomized in a 1:1 ratio to either ataluren or placebo. Six participants (4 in the ataluren arm; 2 in the placebo arm) were excluded from the Intent-to-Treat (ITT) population because they did not have at least 1 post-Baseline forced expiratory volume (FEV1) assessment by Week 8.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description Participants received ataluren 3 times daily (TID): 10 milligrams/kilogram (mg/kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Period Title: Overall Study
Started 120 118
Completed Week 16 107 113
Completed Week 24 103 110
As-Treated Population* [1] 120 118
ITT Population [2] 116 116
Per Protocol Population [3] 100 103
Completed 100 104
Not Completed 20 14
Reason Not Completed
Adverse Event             7             2
Lost to Follow-up             1             0
Withdrawal by Subject             9             9
Physician Decision             1             0
Protocol Violation             1             1
Medical Monitor Decision             1             0
Acquired a Lung Infection             0             1
Sponsor Decision             0             1
[1]

Randomized participants who received at least 1 dose of study drug

*assessed for safety

[2]
Randomized participants with FEV1 data at Baseline and 1 post-Baseline assessment by Week 8
[3]
Randomized participants who completed study treatment and had FEV1 data at Week 48
Arm/Group Title Ataluren Placebo Total
Hide Arm/Group Description Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 120 118 238
Hide Baseline Analysis Population Description
The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 118 participants 238 participants
23.0  (10.06) 23.2  (9.24) 23.1  (9.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 238 participants
Female
58
  48.3%
59
  50.0%
117
  49.2%
Male
62
  51.7%
59
  50.0%
121
  50.8%
1.Primary Outcome
Title Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline
Hide Description Spirometry was used to assess pulmonary function by measuring the percentage of predicted function, which was determined on the basis of the height value obtained at the same study visit, for FEV1 (the amount of air that can be exhaled in 1 second). Spirometry was assessed by using current guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS). Baseline was the average of percent-predicted FEV1 at screening and randomization.
Time Frame Baseline (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: percentage of predicted FEV1
62.092  (13.6159) 60.232  (15.1437)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ataluren, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3264
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48
Hide Description Spirometry was used to assess pulmonary function by measuring the percentage of predicted function, which was determined on the basis of the height value obtained at the same study visit, for FEV1 (the amount of air that can be exhaled in 1 second). Spirometry was assessed by using current guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS). The percentage of change in percent-predicted of FEV1 was calculated as follows: ([percent-predicted FEV1-Baseline percent-predicted FEV1]/Baseline percent-predicted FEV1)*100. Baseline was the average of percent-predicted FEV1 at screening and randomization. A negative change from Baseline indicates that percent-predicted of FEV1 decreased.
Time Frame End of Treatment (EOT) (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: percent change
-2.534  (13.2452) -5.500  (12.5595)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ataluren, Placebo
Comments Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1235
Comments The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.7540
Confidence Interval (2-Sided) 95%
-0.7560 to 6.2640
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78124
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria Over 48 Weeks
Hide Description A Respiratory Event Form, which collected data on various signs, symptoms, and effects for each event, was completed by the Investigator when informed by the participant of a respiratory event. Pulmonary exacerbations were assessed by using the modified Fuchs' criteria, which defines an exacerbation as a respiratory event requiring treatment with parenteral antibiotics for any 4 of the following 12 symptoms, with or without intravenous antibiotics: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; fatigue; temperature >38°C; anorexia; sinus pain; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10% or more from a previously recorded value; or radiographic changes indicative of pulmonary function. The 48-week exacerbation rate was determined by adding the weekly rates for each arm and dividing the sum by 48.
Time Frame Baseline to EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (95% Confidence Interval)
Unit of Measure: exacerbations
1.42
(1.05 to 1.79)
1.78
(1.38 to 2.17)
4.Secondary Outcome
Title Change From Baseline in Awake Cough Hourly Rate at Week 48
Hide Description The frequency of awake cough was measured using the LifeShirt, which incorporates motion-sensing transducers, electrodes, a microphone, and a 3-axis accelerometer into a lightweight vest. The rate was determined by dividing the total number of coughs by 24 (the number of hours of the observation period). Baseline was the latest, valid assessment prior to the treatment. A negative change from Baseline indicates that coughing decreased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: coughs/hour
Baseline Number Analyzed 115 participants 114 participants
28.218  (20.2726) 24.472  (16.7828)
Change From Baseline Number Analyzed 97 participants 100 participants
-0.595  (18.3221) 0.882  (14.3936)
5.Secondary Outcome
Title Change From Baseline in the Respiratory Domain Score of the Revised Cystic Fibrosis Questionnaire (CFQ-R) at Week 48
Hide Description The CFQ-R consists of 44 items, including generic scales of physical functioning, role functioning, vitality, health perceptions, emotional functioning, and social functioning, and CF-specific scales of respiratory and digestive symptoms, body image, eating disturbances, and treatment burden. Each domain score ranges from 1 to 4. Scores were linearly transformed to a 0 to 100 scale, with higher scores indicating better health. Domain scores were calculated by using the following formula: 100 * (sum of responses - minimum possible sum)/ (maximum possible sum - minimum possible sum). The minimum possible sum = number of questions * 1; the maximum possible = the number of questions * 4. Baseline was the latest, valid assessment prior to the treatment. A negative change from Baseline indicates that health has worsened. Participants may have switched age groups during the study.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aged 6-13 years, Baseline Number Analyzed 18 participants 13 participants
77.78  (11.070) 79.49  (16.879)
Aged 6-13 years, Change From Baseline Number Analyzed 12 participants 7 participants
-0.69  (12.028) -3.57  (21.973)
Age ≥14 years , Baseline Number Analyzed 95 participants 101 participants
70.06  (15.678) 65.95  (16.771)
Age ≥14 years, Change From Baseline Number Analyzed 81 participants 92 participants
-2.81  (18.365) -3.32  (16.245)
6.Secondary Outcome
Title Percent-Predicted of Forced Vital Capacity (FVC) at Baseline
Hide Description Spirometry was used to assess pulmonary function by measuring the percentage of predicted function, which was determined on the basis of the height value obtained at the same study visit, for FVC (the amount of air that can be exhaled after taking a deep breath). Spirometry was assessed by using current guidelines of the ATS and ERS. Baseline was the average of percent-predicted FVC at screening and randomization.
Time Frame Baseline (Week 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed ‘signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: percentage of predicted FVC
78.332  (13.1825) 76.609  (13.3711)
7.Secondary Outcome
Title Percentage Change From Baseline in Percent-Predicted of FVC at Week 48
Hide Description Spirometry was used to assess pulmonary function by measuring the percentage of predicted function, which was determined on the basis of the height value obtained at the same study visit, for FVC (the amount of air that can be exhaled after taking a deep breath). Spirometry was assessed by using current guidelines of the ATS and ERS. The percentage of change in percent-predicted of FVC was calculated as follows: ((percent-predicted FVC-Baseline percent-predicted FVC)/Baseline percent-predicted FVC)*100. Baseline was the average of percent-predicted FVC at screening and randomization. A negative change from Baseline indicates that percent-predicted of FVC decreased.
Time Frame EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed ‘signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: percent change
-2.139  (10.0463) -3.484  (9.9304)
8.Other Pre-specified Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description A TEAE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship that occurred or worsened in the period extending from first dose of study drug to 4 weeks after the last dose of study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. AE severity was graded as follows: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening; Grade 5: fatal. A TEAE was considered related if in the opinion of the Investigator it was possibly or probably caused by the study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Adverse Events module.
Time Frame Baseline up to 4 Weeks Post-Treatment (Week 52) or Premature Discontinuation (PD)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 120 118
Measure Type: Number
Unit of Measure: percent of participants
At least 1 TEAE 98.3 97.5
Grade 1 TEAE 15.0 16.9
Grade 2 TEAE 67.5 55.1
Grade 3 TEAE 15.8 25.4
Grade 4 TEAE 0 0
Grade 5 TEAE 0 0
Unrelated TEAE 25.0 35.6
Unlikely related TEAE 32.5 26.3
Possibly related TEAE 28.3 29.7
Probably related TEAE 12.5 5.9
Discontinuation due to TEAE 6.7 2.5
Serious TEAE 37.5 40.7
9.Other Pre-specified Outcome
Title Rate of Study Drug Compliance by Drug Accountability
Hide Description Study drug compliance was assessed by using a Pharmacy Subject Study Drug Accountability Log (completed by the investigational site personnel). The rate of compliance was defined as 100 * (number of sachets taken/number of planned sachets) during the study. All calculations were based on the records of the first dose date to the last dose date. To differentiate dose strengths while maintaining the blind, each kit had a unique kit number and had prominent lettering "A" and "B." Each kit contained 65 packets of 1 of the dose strengths (125, 250, or 1000 mg or matching placebo). Labeling for active drug and placebo was identical.
Time Frame Baseline up to EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 120 118
Median (Full Range)
Unit of Measure: percent of doses taken
Drug Kit A
90.149
(18.24 to 109.24)
85.119
(28.36 to 125.79)
Drug Kit B
90.830
(13.27 to 116.67)
86.614
(25.22 to 107.60)
10.Other Pre-specified Outcome
Title Rate of Study Drug Compliance by Patient-Reported Data
Hide Description Patient-reported data were obtained from the participant's electronic daily diary, which was completed by the participant or the caregiver. During study treatment, the electronic daily diary was to be completed by the participant or caregiver each day for each dose. For each participant, compliance is described in terms of the percentage of study drug actually taken. All calculations were based on the records of the first dose date to the last dose date. To differentiate dose strengths while maintaining the blind, each kit had a unique kit number and had prominent lettering "A" and "B." Each kit contained 65 packets of 1 of the dose strengths (125, 250, or 1000 mg or matching placebo). Labeling for active drug and placebo was identical.
Time Frame Baseline up to EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 120 118
Median (Full Range)
Unit of Measure: percent of doses taken
71.48
(0 to 98.5)
69.27
(6.4 to 98.9)
11.Other Pre-specified Outcome
Title Concentration of Ataluren
Hide Description Blood samples were drawn immediately before administration of the first daily dose (dose taken with breakfast) of study drug and 2 hours after the first daily dose. Whenever possible, the pre-dose sample was to be obtained within 15 minutes of drug administration. Participants in the Placebo arm did not receive Ataluren and are not included in this Outcome Measure.
Time Frame Predose and 2 Hours Postdose at Week 1, Week 16, Week 32, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Ataluren
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 120
Median (Full Range)
Unit of Measure: micrograms/milliliter (ug/mL)
Week 1 Predose Number Analyzed 119 participants
0
(0 to 0)
Week 1 Postdose Number Analyzed 117 participants
14.100
(1.42 to 56.40)
Week 16 Predose Number Analyzed 103 participants
4.350
(0 to 52.60)
Week 16 Postdose Number Analyzed 104 participants
11.900
(0.80 to 41.90)
Week 32 Predose Number Analyzed 99 participants
4.630
(0 to 29.20)
Week 32 Postdose Number Analyzed 97 participants
13.400
(2.37 to 36.30)
Week 48 Predose Number Analyzed 97 participants
3.970
(0 to 27.00)
Week 48 Postdose Number Analyzed 96 participants
10.500
(0 to 39.10)
12.Other Pre-specified Outcome
Title Rate of Interventions for Respiratory Symptoms
Hide Description During treatment, any intervention including hospitalization or use of oral, inhaled, or intravenous antibiotics was documented if it was due to an exacerbation-like episode. Participants and caregivers recorded interventions in an electronic diary. The rate of interventions was defined as the total days with interventions divided by the total study duration.
Time Frame Baseline up to EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for specified categories.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: days with interventions per study
Hospitalization 0.010  (0.0222) 0.021  (0.0469)
Use of Antibiotics 0.220  (0.2284) 0.245  (0.2380)
13.Other Pre-specified Outcome
Title Rate of Disruptions in Activities of Daily Living Because of Pulmonary Symptoms
Hide Description During treatment, any disruption in the activities of daily living, such as missed school or work, was documented if it was due to an exacerbation-like episode. Participants and caregivers recorded all disruptions in an electronic diary. The rate of disruptions was defined as the total days with disruptions to daily living divided by the total study duration.
Time Frame Baseline up to EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for specified categories.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: days with disruptions per study
0.037  (0.0550) 0.047  (0.0755)
14.Other Pre-specified Outcome
Title Change From Baseline in Body Weight at Week 48
Hide Description Participants were weighed, and the weight was recorded at Baseline and then every 8 weeks during the treatment period. Baseline was the latest valid assessment prior to the treatment. A positive change from Baseline indicates that weight increased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: kg
Baseline Number Analyzed 116 participants 116 participants
53.46  (13.941) 56.01  (13.149)
Change From Baseline Number Analyzed 100 participants 104 participants
0.87  (3.342) 0.83  (3.101)
15.Other Pre-specified Outcome
Title Change From Baseline in the Concentration of Interleukin-8 (IL-8) in Serum and Sputum at Week 48
Hide Description Expression of IL-8 was measured in serum and in sputum. Sputum was spontaneously produced and tested by using standardized procedures developed by the Cystic Fibrosis Foundation Therapeutics, Inc. Therapeutics Development Network (CFFT-TDN). Baseline was the latest valid assessment prior to the treatment. A negative change from Baseline indicates that the concentration of IL-8 decreased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: picograms/mL
Serum, Baseline Number Analyzed 115 participants 116 participants
39.537  (14.1697) 55.845  (131.8505)
Serum, Change From Baseline Number Analyzed 96 participants 103 participants
-2.334  (13.2141) -16.197  (138.3108)
Sputum, Baseline Number Analyzed 94 participants 95 participants
267629.93  (259089.569) 250170.95  (180581.976)
Sputum, Change From Baseline Number Analyzed 73 participants 81 participants
28882.79  (199160.845) 9957.24  (166348.660)
16.Other Pre-specified Outcome
Title Change From Baseline in the Concentration of Neutrophil Elastase in Sputum at Week 48
Hide Description Expression of neutrophil elastase was measured in sputum. Sputum was spontaneously produced and tested by using standardized procedures developed by the CFFT-TDN. Baseline was the latest valid assessment prior to the treatment. A positive change from Baseline indicates that the concentration of neutrophil elastase increased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure. Twenty-two participants each in the ataluren and placebo groups were not evaluable.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 94 94
Mean (Standard Deviation)
Unit of Measure: ug/mL
Baseline Number Analyzed 94 participants 94 participants
183.64  (221.901) 227.35  (227.881)
Change From Baseline Number Analyzed 73 participants 80 participants
5.45  (232.824) -8.67  (296.105)
17.Other Pre-specified Outcome
Title Change From Baseline in the Concentration of C-Reactive Protein (CRP) in Serum at Week 48
Hide Description Expression of CRP was measured in serum. Baseline was the latest valid assessment prior to the treatment. A positive change from Baseline indicates that CRP concentration increased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: mg/liter (L)
Baseline Number Analyzed 115 participants 116 participants
6.899  (11.5869) 7.037  (8.4411)
Change From Baseline Number Analyzed 96 participants 103 participants
2.420  (10.5162) 2.031  (10.1202)
18.Other Pre-specified Outcome
Title Change From Baseline in the Total Lung Score as Assessed by Computed Tomography (CT) at Week 48
Hide Description Lungs were imaged by using non-contrast, spiral CT. The total lung score for each CT scan was established by the sum of 5 characteristics from the Brody scoring system, with scores ranging from 0 to 40.5, with lower scores indicating better lung function. The characteristics scored were bronchiectasis (score range 0 - 12), mucus plugging (score range 0- 6), peribronchial thickening (score range 0 - 9), parenchyma (score range 0 - 9), and hyperinflation (score range 0 - 4.5). Baseline was the latest valid assessment prior to the treatment. A positive change from Baseline indicates that lung function worsened.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure. Eleven and 10 participants in the ataluren and placebo groups, respectively, were not evaluable.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 105 participants 106 participants
9.531  (3.7526) 9.619  (3.4244)
Change From Baseline Number Analyzed 99 participants 104 participants
0.282  (1.3441) 0.560  (1.5602)
19.Other Pre-specified Outcome
Title Change From Baseline in Total Nasal Chloride Transport as Assessed by Transepithelial Potential Difference (TEPD) at Week 48
Hide Description TEPD was assessed in each nostril using standardized equipment, techniques, and solutions. Assessments were made on the nasal epithelium cells lining the inferior turbinate. Warmed solutions of Ringer's solution, amiloride, chloride-free gluconate, isoproterenol, and adenosine triphosphate (ATP) were perfused for ≥3-minute sequentially through a nasal catheter while a voltage tracing was recorded. Total chloride transport was computed for each nostril. The total chloride transport values were calculated by subtracting the voltages at the end of a perfusion from the voltage at the end of an earlier perfusion (isoproterenol - amiloride). The average of the values for each nostril was computed. If the assessment was available in only 1 nostril, this value was used as if it were the average of both nostrils. Baseline was the latest, valid assessment prior to the treatment. A positive change from Baseline indicates that nasal chloride transport increased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: millivolts
Baseline Number Analyzed 116 participants 116 participants
1.578  (3.8786) 1.950  (3.5462)
Change From Baseline Number Analyzed 100 participants 104 participants
0.312  (5.0574) 0.139  (5.8139)
20.Other Pre-specified Outcome
Title Change From Baseline in Sweat Chloride Concentration at Week 48
Hide Description Sweat was collected, from each arm, by using pilocarpine iontophoresis. The chloride concentration in the sweat was quantified for each arm by using standard laboratory methods. Tests were also considered valid if the sweat collection time was ≤35 minutes; tests with longer collection times were also considered valid if extra time was needed to obtain sufficient volume (≥15uL) for analysis. For analysis purposes, the average of the values from each arm were computed. If the assessment was valid and/or available in only 1 arm, this value was used as if it were the average of both arms. The method used was consistent with the CFFT-TDN guidelines. Baseline was the latest, valid assessment prior to the treatment. A negative change from Baseline indicates that sweat chloride concentration decreased.
Time Frame Baseline, EOT (Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, ‘Number analyzed' signifies participants evaluable for this outcome measure. Two and 5 participants in the ataluren and placebo groups, respectively, were not evaluable.
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description:
Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
Overall Number of Participants Analyzed 114 111
Mean (Standard Deviation)
Unit of Measure: millimoles/L
Baseline Number Analyzed 114 participants 111 participants
100.140  (14.2170) 96.586  (15.9279)
Change From Baseline Number Analyzed 97 participants 97 participants
-1.325  (8.9431) -0.619  (10.2657)
Time Frame Baseline up to 4 Weeks Post-Treatment (Week 52) or Premature Discontinuation (PD)
Adverse Event Reporting Description The As-Treated Population: all randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Ataluren Placebo
Hide Arm/Group Description Participants received ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks. Participants received placebo TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total daily dose 40 mg/kg). Treatment continued for 48 weeks, after which participants were followed for 4 weeks.
All-Cause Mortality
Ataluren Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ataluren Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/120 (38.33%)      50/118 (42.37%)    
Gastrointestinal disorders     
Haematemesis  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Intussusception  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Pancreatitis  1  1/120 (0.83%)  1 1/118 (0.85%)  1
Abdominal pain  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Constipation  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Gastrointestinal obstruction  1  0/120 (0.00%)  0 1/118 (0.85%)  1
General disorders     
Pyrexia  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Drug withdrawal syndrome  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Hepatobiliary disorders     
Biliary colic  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Cholelithiasis  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/120 (0.83%)  1 1/118 (0.85%)  1
Infections and infestations     
Pneumonia  1  2/120 (1.67%)  2 0/118 (0.00%)  0
Appendicitis  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Pneumonia mycoplasmal  1  1/120 (0.83%)  2 0/118 (0.00%)  0
Urinary tract infection  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Bronchopulmonary aspergillosis allergic  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Gastroenteritis  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Influenza  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Mycobacterium abscessus infection  1  0/120 (0.00%)  0 2/118 (1.69%)  2
Injury, poisoning and procedural complications     
Post procedural haemorrhage  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Joint injury  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/120 (0.83%)  1 1/118 (0.85%)  1
Anorexia  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Musculoskeletal and connective tissue disorders     
Hypercreatinaemia  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Psychiatric disorders     
Depression  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Renal and urinary disorders     
Renal failure  1  3/120 (2.50%)  3 0/118 (0.00%)  0
Renal failure acute  1  3/120 (2.50%)  3 0/118 (0.00%)  0
Renal colic  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Urinary retention  1  1/120 (0.83%)  1 0/118 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cystic fibrosis long  1  34/120 (28.33%)  47 41/118 (34.75%)  66
Haemoptysis  1  2/120 (1.67%)  2 3/118 (2.54%)  3
Nasal polyps  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Vascular disorders     
Thrombosis  1  0/120 (0.00%)  0 1/118 (0.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ataluren Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   118/120 (98.33%)      115/118 (97.46%)    
Gastrointestinal disorders     
Abdominal pain  1  20/120 (16.67%)  14/118 (11.86%) 
Vomiting  1  14/120 (11.67%)  11/118 (9.32%) 
Diarrhoea  1  13/120 (10.83%)  21/118 (17.80%) 
Abdominal pain upper  1  11/120 (9.17%)  7/118 (5.93%) 
Nausea  1  11/120 (9.17%)  13/118 (11.02%) 
Constipation  1  7/120 (5.83%)  9/118 (7.63%) 
General disorders     
Pyrexia  1  17/120 (14.17%)  22/118 (18.64%) 
Fatigue  1  11/120 (9.17%)  11/118 (9.32%) 
Infections and infestations     
Viral upper respiratory tract infection  1  21/120 (17.50%)  32/118 (27.12%) 
Sinusitis  1  15/120 (12.50%)  14/118 (11.86%) 
Rhinitis  1  12/120 (10.00%)  13/118 (11.02%) 
Nasopharyngitis  1  10/120 (8.33%)  8/118 (6.78%) 
Pharyngitis  1  7/120 (5.83%)  4/118 (3.39%) 
Upper respiratory tract infection  1  5/120 (4.17%)  12/118 (10.17%) 
Metabolism and nutrition disorders     
Abnormal loss of weight  1  10/120 (8.33%)  5/118 (4.24%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  8/120 (6.67%)  6/118 (5.08%) 
Hypercreatinaemia  1  8/120 (6.67%)  1/118 (0.85%) 
Nervous system disorders     
Headache  1  20/120 (16.67%)  14/118 (11.86%) 
Renal and urinary disorders     
Nephrolithiasis  1  8/120 (6.67%)  4/118 (3.39%) 
Dysuria  1  7/120 (5.83%)  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders     
Cystic fibrosis lung  1  85/120 (70.83%)  82/118 (69.49%) 
Cough  1  28/120 (23.33%)  35/118 (29.66%) 
Productive cough  1  12/120 (10.00%)  11/118 (9.32%) 
Haemoptysis  1  9/120 (7.50%)  16/118 (13.56%) 
Rales  1  6/120 (5.00%)  6/118 (5.08%) 
Respiratory tract congestion  1  5/120 (4.17%)  8/118 (6.78%) 
Oropharyngeal pain  1  4/120 (3.33%)  14/118 (11.86%) 
Bronchospasm  1  1/120 (0.83%)  6/118 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the sponsor for review. The sponsor may consult with the PI to require changes to the communication or extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patient Advocacy
Organization: PTC Therapeutics, Inc.
Phone: 1-866-562-4620
EMail: medinfo@ptcbio.com
Layout table for additonal information
Responsible Party: PTC Therapeutics
ClinicalTrials.gov Identifier: NCT00803205    
Other Study ID Numbers: PTC124-GD-009-CF
Orphan Product Grant #FD003715 ( Other Grant/Funding Number: Funding Source - FDA OOPD )
2008-003924-52 ( EudraCT Number )
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: April 17, 2020
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020