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Trial record 2 of 3 for:    CNP520

Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

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: NCT02576639
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : May 25, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Alzheimer's Disease
Interventions Drug: CNP520
Drug: Placebo
Enrollment 124
Recruitment Details  
Pre-assignment Details Participants were randomized in a 1:1:1:1:1 ratio to 5 treatment groups: placebo, CNP520 2 mg, CNP520 10 mg, CNP520 35 mg and CNP520 85 mg.
Arm/Group Title Placebo CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. CNP520 2 mg was taken qd orally for 13 weeks. CNP520 10 mg was taken qd orally for 13 weeks. CNP520 35 mg was taken qd orally for 13 weeks. CNP520 85 mg was taken qd orally for 13 weeks.
Period Title: Overall Study
Started 24 25 25 26 24
Pharmacodynamic Analysis Set 24 24 25 25 25
Pharmacokinetic Analysis Set 0 25 25 26 24
Safety Analysis Set 24 25 25 26 24
Completed 22 23 23 25 20
Not Completed 2 2 2 1 4
Reason Not Completed
Withdrawal by Subject             1             2             1             0             1
Adverse Event             1             0             1             1             2
Physician Decision             0             0             0             0             1
Arm/Group Title Placebo CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg Total
Hide Arm/Group Description Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. CNP520 2 mg was taken qd orally for 13 weeks. CNP520 10 mg was taken qd orally for 13 weeks. CNP520 35 mg was taken qd orally for 13 weeks. CNP520 85 mg was taken qd orally for 13 weeks. Total of all reporting groups
Overall Number of Baseline Participants 24 25 25 26 24 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 25 participants 26 participants 24 participants 124 participants
66.6  (5.3) 65.4  (4.6) 66.8  (5.1) 66.1  (4.6) 66.5  (5.2) 66.3  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 25 participants 26 participants 24 participants 124 participants
Female
12
  50.0%
16
  64.0%
13
  52.0%
11
  42.3%
9
  37.5%
61
  49.2%
Male
12
  50.0%
9
  36.0%
12
  48.0%
15
  57.7%
15
  62.5%
63
  50.8%
1.Primary Outcome
Title Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Hide Description Safety monitoring was conducted throughout the study.
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed.
Arm/Group Title Placebo CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 24 25 25 26 24
Measure Type: Number
Unit of Measure: Participants
Non-serious AEs 18 19 22 20 18
Serious AEs 0 0 0 1 0
Deaths 0 0 0 0 0
2.Secondary Outcome
Title Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Hide Description CSF samples were collected by lumbar puncture for assessment.
Time Frame Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data.
Arm/Group Title Placebo CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 21 22 21 23 20
Mean (Standard Deviation)
Unit of Measure: Percentage change
Aβ 1-38 -2.34  (6.969) -20.55  (10.475) -62.48  (6.202) -82.93  (4.378) -89.5  (1.676)
Aβ 1-40 -2.64  (6.598) -22.64  (9.937) -62.89  (6.485) -83.16  (4.227) -90.69  (1.651)
Aβ 1-42 -2.58  (5.189) -23.93  (8.987) -64.28  (6.086) -82.35  (5.474) -89.68  (2.32)
3.Secondary Outcome
Title Summary of Plasma PK Parameter: Cmax
Hide Description Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.
Time Frame Days 1, 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 25 25 26 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 (n=25,25,26,24) 4.76  (2.92) 21.3  (6.67) 75.6  (23.4) 163  (47.4)
Day 91 (=23,22,24,20) 16.6  (5.51) 81  (29.2) 237  (65.7) 602  (150)
4.Secondary Outcome
Title Summary of Plasma PK Parameter: AUCtau
Hide Description AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.
Time Frame Days 1 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 25 25 26 24
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Day 1 (n=25,25,26,24) 67.1  (60.7) 278  (65.7) 966  (214) 2300  (479)
Day 91 (n=23,22,24,20) 313  (117) 1500  (476) 4450  (1090) 11200  (3320)
5.Secondary Outcome
Title Summary of Plasma PK Parameter: Tmax
Hide Description Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
Time Frame Days 1 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 25 25 26 24
Median (Full Range)
Unit of Measure: hour
Day 1 (n=25,25,26,24)
2.5
(2.45 to 9)
2.5
(2.5 to 6.02)
2.5
(2.48 to 9)
2.5
(2.42 to 12)
Day 91 (n=23,22,24,20)
2.5
(0 to 12.1)
2.5
(0 to 12.5)
2.5
(0 to 12)
2.5
(0 to 12)
6.Secondary Outcome
Title Summary of Plasma PK Parameter: Tlag
Hide Description Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.
Time Frame Days 1 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 25 25 26 24
Median (Full Range)
Unit of Measure: hour
Day 1 (n=25,25,26,24)
0.5
(0 to 0.567)
0.5
(0 to 2.5)
0.5
(0 to 0.55)
0
(0 to 2.5)
Day 91 (n=23,22,24,20)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
7.Secondary Outcome
Title Summary of Plasma PK Parameter: T1/2
Hide Description T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
Time Frame Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 23 22 24 20
Mean (Standard Deviation)
Unit of Measure: hour
150  (52.2) 155  (40.9) 155  (33.9) 160  (22)
8.Secondary Outcome
Title Summary of PK Parameter: CLss/F
Hide Description CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.
Time Frame Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 23 22 24 20
Mean (Standard Deviation)
Unit of Measure: mL/h
7620  (2620) 7380  (2480) 8460  (2790) 8220  (2270)
9.Secondary Outcome
Title Summary of Plasma PK Parameter: Racc
Hide Description Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Time Frame Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 23 22 24 20
Mean (Standard Deviation)
Unit of Measure: ratio
5.86  (2.25) 5.33  (1.05) 4.75  (1.16) 5.02  (1.47)
10.Secondary Outcome
Title Summary of CSF PK Concentrations
Hide Description CSF samples were collected by lumbar puncture for assessment.
Time Frame Days 1, 14, 28, 42, 56, 70 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 25 25 26 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 (n=24,25,26,24) 0  (0) 0  (0) 0  (0) 0  (0)
Day 14 (n=3,4,4,4) 0.166  (0.103) 1.07  (0.225) 3.82  (0.868) 8.13  (2.7)
Day 28 (n=5,2,7,5) 0.303  (0.0731) 1.48  (0.106) 4.48  (1.02) 12  (4.12)
Day 42 (n=3,6,5,5) 0.314  (0.0715) 1.52  (0.6) 4  (1.21) 7.47  (1.57)
Day 56 (n=5,5,2,4) 0.291  (0.0605) 1.28  (0.177) 5.03  (2.69) 8.04  (5.69)
Day 70 (n=6,5,6,4) 0.231  (0.149) 1.04  (0.212) 4.62  (0.753) 8.71  (0.71)
Day 91 (n=23,21,24,20) 0.305  (0.099) 1.44  (0.431) 4.52  (0.946) 10.4  (3.26)
11.Secondary Outcome
Title Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
Hide Description CNP520 concentrations in plasma
Time Frame Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
This PK parameter was not analyzed because data was not collected.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F)
Hide Description [Not Specified]
Time Frame Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
This PK parameter was not analyzed because data was not collected.
Arm/Group Title CNP520 2 mg CNP520 10 mg CNP520 35 mg CNP520 85 mg
Hide Arm/Group Description:
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mg was taken qd orally for 13 weeks.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo CNP520 2mg CNP520 10mg CNP520 35mg CNP520 85mg
Hide Arm/Group Description Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. CNP520 2 mg was taken qd orally for 13 weeks. CNP520 10 mg was taken qd orally for 13 weeks. CNP520 35 mg was taken qd orally for 13 weeks. CNP520 85 mg was taken qd orally for 13 weeks.
All-Cause Mortality
Placebo CNP520 2mg CNP520 10mg CNP520 35mg CNP520 85mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo CNP520 2mg CNP520 10mg CNP520 35mg CNP520 85mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   1/26 (3.85%)   0/24 (0.00%) 
Injury, poisoning and procedural complications           
Ankle fracture  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo CNP520 2mg CNP520 10mg CNP520 35mg CNP520 85mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/24 (75.00%)   19/25 (76.00%)   22/25 (88.00%)   20/26 (76.92%)   18/24 (75.00%) 
Blood and lymphatic system disorders           
Iron deficiency anaemia  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Ear and labyrinth disorders           
Ear discomfort  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Ear pain  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Eustachian tube dysfunction  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Tinnitus  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Eye disorders           
Asthenopia  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dry eye  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Eye irritation  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Eye pain  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Eye pruritus  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  1/24 (4.17%) 
Lacrimation increased  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Ocular hyperaemia  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Vision blurred  1  1/24 (4.17%)  1/25 (4.00%)  2/25 (8.00%)  0/26 (0.00%)  1/24 (4.17%) 
Visual impairment  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders           
Abdominal distension  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Abdominal pain  1  2/24 (8.33%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Abdominal pain upper  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Constipation  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  2/26 (7.69%)  1/24 (4.17%) 
Diarrhoea  1  5/24 (20.83%)  1/25 (4.00%)  3/25 (12.00%)  1/26 (3.85%)  1/24 (4.17%) 
Dry mouth  1  1/24 (4.17%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dyspepsia  1  0/24 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  1/26 (3.85%)  0/24 (0.00%) 
Eructation  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Faeces hard  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Faeces soft  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Flatulence  1  1/24 (4.17%)  1/25 (4.00%)  3/25 (12.00%)  1/26 (3.85%)  0/24 (0.00%) 
Frequent bowel movements  1  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Gastrooesophageal reflux disease  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Glossodynia  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Nausea  1  2/24 (8.33%)  2/25 (8.00%)  3/25 (12.00%)  2/26 (7.69%)  2/24 (8.33%) 
Toothache  1  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  1/24 (4.17%) 
Vomiting  1  1/24 (4.17%)  2/25 (8.00%)  0/25 (0.00%)  2/26 (7.69%)  0/24 (0.00%) 
General disorders           
Asthenia  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Fatigue  1  3/24 (12.50%)  0/25 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  2/24 (8.33%) 
Feeling cold  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Influenza like illness  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/24 (4.17%) 
Injection site pain  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  2/24 (8.33%) 
Pain  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Puncture site pain  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Vessel puncture site haemorrhage  1  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Vessel puncture site pain  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Vessel puncture site swelling  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Immune system disorders           
Allergy to chemicals  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Infections and infestations           
Abscess  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Abscess jaw  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Bronchitis  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Hordeolum  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Nasopharyngitis  1  4/24 (16.67%)  2/25 (8.00%)  5/25 (20.00%)  4/26 (15.38%)  1/24 (4.17%) 
Oral herpes  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Rhinitis  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Sinusitis  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Tinea pedis  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Upper respiratory tract infection  1  2/24 (8.33%)  1/25 (4.00%)  2/25 (8.00%)  1/26 (3.85%)  0/24 (0.00%) 
Urinary tract infection  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Injury, poisoning and procedural complications           
Arthropod bite  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Contusion  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Ear abrasion  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Foreign body in eye  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Joint dislocation  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Laceration  1  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  2/26 (7.69%)  1/24 (4.17%) 
Ligament sprain  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Limb injury  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Post lumbar puncture syndrome  1  8/24 (33.33%)  2/25 (8.00%)  1/25 (4.00%)  3/26 (11.54%)  3/24 (12.50%) 
Post procedural discomfort  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  0/24 (0.00%) 
Post procedural haemorrhage  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Procedural complication  1  1/24 (4.17%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Procedural dizziness  1  2/24 (8.33%)  0/25 (0.00%)  3/25 (12.00%)  2/26 (7.69%)  0/24 (0.00%) 
Procedural nausea  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/24 (4.17%) 
Procedural pain  1  1/24 (4.17%)  3/25 (12.00%)  4/25 (16.00%)  2/26 (7.69%)  3/24 (12.50%) 
Scratch  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Skin abrasion  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Thermal burn  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Traumatic lumbar puncture  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Wound complication  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Investigations           
Amylase increased  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Blood bilirubin increased  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Blood cholesterol increased  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Blood creatine phosphokinase increased  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Blood triglycerides increased  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Gamma-glutamyltransferase increased  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Lipase increased  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Weight decreased  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Metabolism and nutrition disorders           
Gout  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Increased appetite  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/24 (4.17%)  2/25 (8.00%)  3/25 (12.00%)  3/26 (11.54%)  1/24 (4.17%) 
Back pain  1  6/24 (25.00%)  2/25 (8.00%)  2/25 (8.00%)  3/26 (11.54%)  4/24 (16.67%) 
Joint stiffness  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Joint swelling  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Muscle spasms  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/24 (0.00%) 
Muscle tightness  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Muscular weakness  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Musculoskeletal discomfort  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Musculoskeletal pain  1  0/24 (0.00%)  2/25 (8.00%)  1/25 (4.00%)  1/26 (3.85%)  1/24 (4.17%) 
Musculoskeletal stiffness  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/24 (8.33%) 
Myalgia  1  3/24 (12.50%)  0/25 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/24 (4.17%) 
Neck pain  1  1/24 (4.17%)  2/25 (8.00%)  0/25 (0.00%)  1/26 (3.85%)  1/24 (4.17%) 
Pain in extremity  1  2/24 (8.33%)  2/25 (8.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Plantar fasciitis  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Seborrhoeic keratosis  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Nervous system disorders           
Amnesia  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Balance disorder  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Cognitive disorder  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dizziness  1  3/24 (12.50%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Dizziness postural  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dysarthria  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dysgeusia  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Head discomfort  1  1/24 (4.17%)  1/25 (4.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Headache  1  10/24 (41.67%)  11/25 (44.00%)  5/25 (20.00%)  5/26 (19.23%)  5/24 (20.83%) 
Lethargy  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Neuropathy peripheral  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Presyncope  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Sedation  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Sinus headache  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Somnolence  1  1/24 (4.17%)  1/25 (4.00%)  0/25 (0.00%)  2/26 (7.69%)  1/24 (4.17%) 
Syncope  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Tension headache  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Visual field defect  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Psychiatric disorders           
Abnormal dreams  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  1/26 (3.85%)  1/24 (4.17%) 
Affective disorder  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Confusional state  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Irritability  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Libido decreased  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Nightmare  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Obsessive thoughts  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Renal and urinary disorders           
Micturition urgency  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Pollakiuria  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/24 (4.17%) 
Polyuria  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Erectile dysfunction  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Pruritus genital  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/24 (4.17%)  2/25 (8.00%)  3/25 (12.00%)  3/26 (11.54%)  3/24 (12.50%) 
Dysphonia  1  2/24 (8.33%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Dyspnoea  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Epistaxis  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Hiccups  1  0/24 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Nasal congestion  1  2/24 (8.33%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  1/24 (4.17%) 
Oropharyngeal pain  1  4/24 (16.67%)  2/25 (8.00%)  2/25 (8.00%)  2/26 (7.69%)  0/24 (0.00%) 
Productive cough  1  1/24 (4.17%)  1/25 (4.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Rhinorrhoea  1  2/24 (8.33%)  0/25 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  1/24 (4.17%) 
Sinus congestion  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Throat irritation  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Skin and subcutaneous tissue disorders           
Cold sweat  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Dermatitis  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Dermatitis contact  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Dry skin  1  1/24 (4.17%)  0/25 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Ecchymosis  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/24 (8.33%) 
Erythema  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Pruritus  1  0/24 (0.00%)  0/25 (0.00%)  3/25 (12.00%)  0/26 (0.00%)  0/24 (0.00%) 
Pruritus generalised  1  0/24 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  0/26 (0.00%)  1/24 (4.17%) 
Psoriasis  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Rash  1  0/24 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Rash papular  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/24 (0.00%) 
Rash pruritic  1  0/24 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Vascular disorders           
Flushing  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/24 (4.17%) 
Hot flush  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02576639    
Other Study ID Numbers: CCNP520X2102
2013-005576-18 ( EudraCT Number )
First Submitted: August 18, 2015
First Posted: October 15, 2015
Results First Submitted: March 9, 2017
Results First Posted: May 25, 2017
Last Update Posted: August 11, 2017