18 and older, any sex, with Painful Diabetic Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12Primary· Baseline up to Week 12
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.
Week 4
Group
Value
95% CI
EMA401 100mg BID DB
-1.0
± 0.21
Placebo BID DB
-0.8
± 0.18
Week 8
Group
Value
95% CI
EMA401 100mg BID DB
-1.7
± 0.29
Placebo BID DB
-1.1
± 0.26
Week 12
Group
Value
95% CI
EMA401 100mg BID DB
-1.9
± 0.31
Placebo BID DB
-1.3
± 0.27
Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12Secondary· Baseline up to Week 12
The 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.
Week 4
Group
Value
95% CI
EMA401 100mg BID DB
-1.2
± 0.19
Placebo BID DB
-1.0
± 0.18
Week 8
Group
Value
95% CI
EMA401 100mg BID DB
-1.3
± 0.25
Placebo BID DB
-0.9
± 0.22
Week 12
Group
Value
95% CI
EMA401 100mg BID DB
-1.6
± 0.32
Placebo BID DB
-1.1
± 0.26
Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12Secondary· Baseline up to Week 12
The 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 scale with zero being "does not interfere" and ten being "completely interferes". The BPI total score is the sum of the 7 items. Each item ranges from 0 to 10, thus the total score ranges from 0 to 70. Lower values indicate a better outcome.
Group
Value
95% CI
EMA401 100mg BID DB
-12.03
± 13.336
Placebo BID DB
-10.83
± 14.602
Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12Secondary· Baseline up to Week 12
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.
Group
Value
95% CI
EMA401 100mg BID DB
-1.63
± 1.837
Placebo BID DB
-1.28
± 1.577
Number of Participants Per Patient Global Impression of Change Category at Week 12Secondary· Baseline up to Week 12
The 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
Very much improved
Group
Value
95% CI
EMA401 100mg BID DB
4
Placebo BID DB
2
Much improved
Group
Value
95% CI
EMA401 100mg BID DB
7
Placebo BID DB
11
Minimally improved
Group
Value
95% CI
EMA401 100mg BID DB
17
Placebo BID DB
18
No change
Group
Value
95% CI
EMA401 100mg BID DB
18
Placebo BID DB
14
Minimally worse
Group
Value
95% CI
EMA401 100mg BID DB
3
Placebo BID DB
2
Much worse
Group
Value
95% CI
EMA401 100mg BID DB
0
Placebo BID DB
0
Very much worse
Group
Value
95% CI
EMA401 100mg BID DB
0
Placebo BID DB
0
Missing
Group
Value
95% CI
EMA401 100mg BID DB
21
Placebo BID DB
20
Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point ScaleSecondary· Baseline up to Week 12
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% 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.
Week 4 - at least 30% pain reduction
Group
Value
95% CI
EMA401 100mg BID DB
34.0
Placebo BID DB
24.7
Week 12 - at least 30% pain reduction
Group
Value
95% CI
EMA401 100mg BID DB
52.7
Placebo BID DB
40.4
Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point ScaleSecondary· Baseline up to Week 12
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.
Group
Value
95% CI
EMA401 100mg BID DB
31.4
Placebo BID DB
14.1
Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12Secondary· Baseline up to Week 12
Patients were asked to complete the ISI using five-point Likert-style scale as a measure of perceived sleep difficulties. 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. The scale consists of 7 items. The sum of seven items represents the total score. Each of the 7 items is scored using a range from 0 to 4, thus the total score values ranges from zero to 28. Lower values represent better outcomes.
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
Week 8 Prior dose
Group
Value
95% CI
EMA401 100mg BID DB
30.5
± 126.6
Week 8 1-3 hours
Group
Value
95% CI
EMA401 100mg BID DB
205.1
± 212.8
Week 8 4-6 hours
Group
Value
95% CI
EMA401 100mg BID DB
72.8
± 115.2
Week 12 Prior dose
Group
Value
95% CI
EMA401 100mg BID DB
29.5
± 209.3
Week 12 1-3 hours
Group
Value
95% CI
EMA401 100mg BID DB
118.4
± 278.3
Week 12 4-6 hours
Group
Value
95% CI
EMA401 100mg BID DB
89.8
± 117.0
Percentage of Patients Who Required Rescue Medication in Double-blind Treatment PeriodSecondary· Baseline and weekly up to 12 weeks, once during double-blind period
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Percentages of patients presented are those who required rescue meds within 7 days prior to visit.
Week 1
Group
Value
95% CI
EMA401 100mg BID DB
13.0
Placebo BID DB
10.6
Week 2
Group
Value
95% CI
EMA401 100mg BID DB
7.7
Placebo BID DB
9.5
Week 4
Group
Value
95% CI
EMA401 100mg BID DB
8.6
Placebo BID DB
7.0
Week 6
Group
Value
95% CI
EMA401 100mg BID DB
7.8
Placebo BID DB
7.5
Week 8
Group
Value
95% CI
EMA401 100mg BID DB
9.3
Placebo BID DB
9.5
Week 10
Group
Value
95% CI
EMA401 100mg BID DB
5.3
Placebo BID DB
13.2
Week 12
Group
Value
95% CI
EMA401 100mg BID DB
2.9
Placebo BID DB
8.6
At least once during double-blind period
Group
Value
95% CI
EMA401 100mg BID DB
20.0
Placebo BID DB
19.4
Percentage of Patients Who Required Rescue Medication in Treatment Withdrawal PeriodSecondary· Week 12 to Week 13 (planned duration subject to varibility in visit scheduling)
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Percentages of patients presented are those who required rescue meds within 7 days prior to visit.
Group
Value
95% CI
EMA401 100mg BID -> EMA401 100mg BID TW
14.3
EMA401 100mg BID -> Placebo BID TW
8.3
Placebo BID -> Placebo BID TW
7.4
Time to First Rescue Medication IntakeSecondary· Baseline up to day 92
Patients were allowed to take acetaminophen/paracetamol up to a maximum of 3 g daily (divided into 4 times/day) for unacceptable pain due to any reason during the study. This medication use was to be recorded in eDiary prior to use. Patients who did not take any rescue medication were censored at the last date of double-blind treatment period.
Group
Value
95% CI
EMA401 100mg BID DB
44.0
2 – 90
Placebo BID DB
56.5
2 – 92
Adverse events — posted to ClinicalTrials.gov
Time frame: 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 111 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT03094195 — Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 8 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03297294.