Trial Outcomes & Findings for Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN) (NCT NCT03094195)
NCT ID: NCT03094195
Last Updated: 2021-10-08
Results Overview
Since the 300 mg b.i.d. dose of EMA401 could not be initiated in the study due to premature study termination, the dose-response characterization was not performed. Specifically, only the trend test deduced from the set of candidate models was performed but the dose response estimation was not conducted.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline up to Week 12
Results posted on
2021-10-08
Participant Flow
Two hundred thirty patients were screened.
Participant milestones
| Measure |
EMA401 25mg BID DB
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 25mg BID -> EMA401 25mg BID TW
Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
|
EMA401 25mg BID -> Placebo BID TW
Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
|
EMA401 100mg BID -> EMA401 100mg BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period (DB)
STARTED
|
43
|
43
|
43
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
COMPLETED
|
28
|
30
|
29
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
NOT COMPLETED
|
15
|
13
|
14
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Withdrawal Period (TW)
STARTED
|
0
|
0
|
0
|
13
|
13
|
15
|
13
|
26
|
|
Treatment Withdrawal Period (TW)
COMPLETED
|
0
|
0
|
0
|
13
|
13
|
15
|
13
|
26
|
|
Treatment Withdrawal Period (TW)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
EMA401 25mg BID DB
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 25mg BID -> EMA401 25mg BID TW
Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
|
EMA401 25mg BID -> Placebo BID TW
Participants on EMA401 25mg were randomized 1:1 to EMA401 25mg or placebo at end of treatment period (week 12)
|
EMA401 100mg BID -> EMA401 100mg BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
EMA401 100mg BID -> Placebo BID TW
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID TW
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|---|---|---|
|
Double-Blind Treatment Period (DB)
Study terminated by sponsor
|
12
|
10
|
11
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Adverse Event
|
3
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DB)
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
Baseline characteristics by cohort
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 - 64 years
|
4 participants
n=93 Participants
|
8 participants
n=4 Participants
|
7 participants
n=27 Participants
|
19 participants
n=483 Participants
|
|
Age, Customized
65 - 84 years
|
36 participants
n=93 Participants
|
34 participants
n=4 Participants
|
36 participants
n=27 Participants
|
106 participants
n=483 Participants
|
|
Age, Customized
≥ 85 years
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
4 participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
33 participants
n=93 Participants
|
32 participants
n=4 Participants
|
32 participants
n=27 Participants
|
97 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
29 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Body mass index
|
25.9 kg/m2
n=93 Participants
|
25.2 kg/m2
n=4 Participants
|
24.9 kg/m2
n=27 Participants
|
25.4 kg/m2
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 12Population: Due to premature study termination 300 mg BID dose was not initiated
Since the 300 mg b.i.d. dose of EMA401 could not be initiated in the study due to premature study termination, the dose-response characterization was not performed. Specifically, only the trend test deduced from the set of candidate models was performed but the dose response estimation was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: number of patients with observed change from baseline on respective visit.
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 4
|
-0.4 scores on a scale
Standard Error 0.23
|
-0.9 scores on a scale
Standard Error 0.25
|
-0.5 scores on a scale
Standard Error 0.23
|
—
|
—
|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 8
|
-1.0 scores on a scale
Standard Error 0.29
|
-1.0 scores on a scale
Standard Error 0.29
|
-0.7 scores on a scale
Standard Error 0.30
|
—
|
—
|
|
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12
Week 12
|
-0.9 scores on a scale
Standard Error 0.40
|
-1.2 scores on a scale
Standard Error 0.38
|
-0.7 scores on a scale
Standard Error 0.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The BPI-SF is a validated, self-administered (at clinic) questionnaire that assesses pain severity and its mpact on daily functions. Patients were asked to complete the 7-item pain interference scale that assessed the degree to which pain interfered with walking and other physical activity, work, mood, relations with others and sleep using a zero to ten numeric rating scale (NRS) with zero being "does not interfere" and ten being "completely interferes". A reduction in mean indicates improvement
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12
|
-8.24 scores on a numeric rating scale
Standard Deviation 12.994
|
-15.03 scores on a numeric rating scale
Standard Deviation 13.280
|
-14.07 scores on a numeric rating scale
Standard Deviation 12.535
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The following parameters were evaluated using the 11-point NRS: 24-hour Average Pain Score and 24-hour Worst Pain Score Patients evaluated their "average pain" and "worst pain" during the past 24 hours in the evening prior to sleep by touching the appropriate corresponding number between zero and ten on a eDiary device.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12
|
-1.04 scores on numeric rating scale
Standard Deviation 1.851
|
-1.96 scores on numeric rating scale
Standard Deviation 2,365
|
-1.49 scores on numeric rating scale
Standard Deviation 2.215
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. The PGIC was to be completed by patients using the electronic tablet at the site
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Much improved
|
2 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Minimally improved
|
9 Participants
|
12 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
No change
|
20 Participants
|
18 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Very much improved
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Minimally worse
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Much worse
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Per Patient Global Impression of Change Category at Week 12
Missing
|
7 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 30% /50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio \>1 = higher chance of a clinically important improvement.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Week 4 - at least 30% pain reduction
|
7.5 % of participants - model adjusted rate
|
15.6 % of participants - model adjusted rate
|
12.6 % of participants - model adjusted rate
|
—
|
—
|
|
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale
Week 12 - at least 30% pain reduction
|
22.3 % of participants - model adjusted rate
|
29.6 % of participants - model adjusted rate
|
23.6 % of participants - model adjusted rate
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. The number of patients with observed response, i.e. a decrease of 50% units in weekly mean of the 24-hour average pain score NRS. Logistic regression model with region, treatment, sex, use of PHN medications (yes/no) as factors and age and baseline NRS as covariates. An odds ratio \>1 = higher chance of a clinically important improvement.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale
|
12.0 % of participants - model adjusted rate
|
13.4 % of participants - model adjusted rate
|
10.3 % of participants - model adjusted rate
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set
Patients were asked to complete the ISI using five-point Likert-style scale as a measure of perceived sleep difficulties. Scores ranged from zero to 28, with a cut-off score of eight suggesting the presence of sub-threshold insomnia. The questionnaire assessed the severity of insomnia, satisfaction with current sleep pattern, sleep interference, "noticeability" of sleeping problem to others and concern about sleeping problems.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12
|
-1.29 scores on a scale
Standard Deviation 4.529
|
-4.14 scores on a scale
Standard Deviation 5.146
|
-3.44 scores on a scale
Standard Deviation 4.228
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 12The Neuropathic Pain Symptom Inventory (NPSI) is a 12 item patient reported outcome measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain and paraesthesia/dysesthesia) and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The sum of the responses to the 10 questions (all except temporal questions) was regarded as the total score and was divided by 10 (10 questions). The range of the total score and of the 5 dimensional scores is 0 to 10. Lower values represent better outcomes.
Outcome measures
| Measure |
EMA401 25mg BID DB
n=43 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=43 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=43 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12
|
-0.4 scores on a scale
Standard Error 0.35
|
-1.0 scores on a scale
Standard Error 0.37
|
-1.0 scores on a scale
Standard Error 0.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 12Population: PK analysis set
Due to the premature termination of the study, the number of patients and observations providing PK data was much smaller than planned, and no PK model was developed. As a consequence, no PK parameters (Cmax, Tmax, AUC) were derived for this study. Only, summary statistics of the plasma concentrations were calculated
Outcome measures
| Measure |
EMA401 25mg BID DB
n=28 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=31 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 Prior dose n=26,31
|
4.8 ng/mL
Geometric Coefficient of Variation 86.3
|
15.9 ng/mL
Geometric Coefficient of Variation 134.0
|
—
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 1-3 hours n=26,31
|
75.9 ng/mL
Geometric Coefficient of Variation 159.9
|
226.9 ng/mL
Geometric Coefficient of Variation 138.5
|
—
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 8 4-6 hours n= n=28,31
|
12.6 ng/mL
Geometric Coefficient of Variation 86.6
|
48.9 ng/mL
Geometric Coefficient of Variation 79.1
|
—
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 Prior dose n=25,28
|
4.9 ng/mL
Geometric Coefficient of Variation 69.3
|
13.6 ng/mL
Geometric Coefficient of Variation 67.7
|
—
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 1-3 hours n=25,27
|
69.3 ng/mL
Geometric Coefficient of Variation 163.7
|
184.00 ng/mL
Geometric Coefficient of Variation 178.4
|
—
|
—
|
—
|
|
Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12
Week 12 4-6 hours n=25,28
|
13.7 ng/mL
Geometric Coefficient of Variation 112.2
|
63.6 ng/mL
Geometric Coefficient of Variation 98.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 12Population: Analysis was not performed
Due to the premature termination of the study, the number of patients providing data for PKPD analysis data was much smaller than planned and no model to correlate drug exposure (PK) with the change in the pain score (PD) was developed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately from 3 weeks after end of study up to 16 weeksPopulation: The Overall Number of Participants Analyzed reflects the Safety population, regardless of whether they completed the study
Participants were instructed to stop taking drug immediately upon termination of study and asked to come in for two unscheduled visits for follow up safety assessments
Outcome measures
| Measure |
EMA401 25mg BID DB
n=22 Participants
Ema401 25 mg was administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID DB
n=21 Participants
Ema401 100 mg was administered orally twice a day during double blind (DB) treatment period
|
Placebo BID DB
n=22 Participants
Matching placebo capsules administered orally twice a day during double blind (DB) treatment period
|
EMA401 100mg BID -> Placebo BID
n=21 Participants
Participants on EMA401 100mg were randomized 1:1 to EMA401 100mg or placebo at end of treatment period (week 12)
|
Placebo BID -> Placebo BID
n=43 Participants
Participants on placebo remained on placebo at end of treatment period (week 12)
|
|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Glomerular filtration rate decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Blood creatinine increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Blood potassium increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up
Blood glucose increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
EMA401 25 mg b.i.d.
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
EMA401 100 mg b.i.d.
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo b.i.d.
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
EMA401 25 mg b.i.d. - Placebo b.i.d.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EMA401 100 mg b.i.d. - Placebo b.i.d.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo b.i.d. - Placebo b.i.d.
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EMA401 25 mg b.i.d.
n=43 participants at risk
EMA401 25 mg b.i.d.
|
EMA401 100 mg b.i.d.
n=43 participants at risk
EMA401 100 mg b.i.d.
|
Placebo b.i.d.
n=43 participants at risk
Placebo b.i.d.
|
EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
n=13 participants at risk
EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
|
EMA401 25 mg b.i.d. - Placebo b.i.d.
n=13 participants at risk
EMA401 25 mg b.i.d. - Placebo b.i.d.
|
EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
n=15 participants at risk
EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
|
EMA401 100 mg b.i.d. - Placebo b.i.d.
n=13 participants at risk
EMA401 100 mg b.i.d. - Placebo b.i.d.
|
Placebo b.i.d. - Placebo b.i.d.
n=26 participants at risk
Placebo b.i.d. - Placebo b.i.d.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
Other adverse events
| Measure |
EMA401 25 mg b.i.d.
n=43 participants at risk
EMA401 25 mg b.i.d.
|
EMA401 100 mg b.i.d.
n=43 participants at risk
EMA401 100 mg b.i.d.
|
Placebo b.i.d.
n=43 participants at risk
Placebo b.i.d.
|
EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
n=13 participants at risk
EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d.
|
EMA401 25 mg b.i.d. - Placebo b.i.d.
n=13 participants at risk
EMA401 25 mg b.i.d. - Placebo b.i.d.
|
EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
n=15 participants at risk
EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d.
|
EMA401 100 mg b.i.d. - Placebo b.i.d.
n=13 participants at risk
EMA401 100 mg b.i.d. - Placebo b.i.d.
|
Placebo b.i.d. - Placebo b.i.d.
n=26 participants at risk
Placebo b.i.d. - Placebo b.i.d.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
9.3%
4/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Investigations
Amylase increased
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Investigations
Lipase increased
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
4.7%
2/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.0%
3/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
2.3%
1/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
7.7%
1/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
0.00%
0/13 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
3.8%
1/26 • Adverse events were collected from first dose of study treatment until end of study treatment plus 21 days post treatment, up to maximum duration of 116 days
Any sign or symptom that occurs during the study treatment plus the 21 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER