Trial · NCT03297294
Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
NCT03297294, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2020-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN). Trials, record NCT03297294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03297294
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
- NCT number
- NCT03297294
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- EMA401, Placebo
- First posted
- 2017-09-29
- Last updated
- 2021-10-08
- Other registries' IDs
- eudract:2016-000281-39
- Results first posted
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | 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. |
| Secondary | Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | 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. |
| Secondary | Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12 | 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. |
| Secondary | Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12 | 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. |
| Secondary | Number of Participants Per Patient Global Impression of Change Category at Week 12 | 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 |
| Secondary | Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale | 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. |
| Secondary | Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale | 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. |
| Secondary | Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12 | 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. |
| Secondary | Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12 | Week 8 (Prior dose, 1-3 hours, 4-6 hours), Week 12 (Prior dose, 1-3 hours, 4-6 hours) | 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 |
| Secondary | Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | Baseline up to Week 12 | Full analysis set | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | Baseline up to Week 12 | scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12 | Baseline up to Week 12 | scores on a scale | MEAN | |
| SECONDARY | Change in Weekly Mean of the 24-hour Worst Pain Score, Using an 11-point NRS, From Baseline to Week 12 | Baseline up to Week 12 | scores on numeric rating scale | MEAN | |
| SECONDARY | Number of Participants Per Patient Global Impression of Change Category at Week 12 | Baseline up to Week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Achieving at Least 30% Pain Reduction at Week 12 on NRS 11 Point Scale | Baseline up to Week 12 | Full analysis set | % of participants - model adjusted rate | NUMBER |
| SECONDARY | Percentage of Patients Achieving at Least 50% Pain Reduction at Week 12 on NRS 11 Point Scale | Baseline up to Week 12 | Full analysis set | % of participants - model adjusted rate | NUMBER |
| SECONDARY | Mean Change in Insomnia Severity Index (ISI) From Baseline to Week 12 | Baseline up to Week 12 | Full analysis set | scores on a scale | MEAN |
| SECONDARY | Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12 | Week 8 (Prior dose, 1-3 hours, 4-6 hours), Week 12 (Prior dose, 1-3 hours, 4-6 hours) | PK analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Patients Who Required Rescue Medication in Double-blind Treatment Period | Baseline and weekly up to 12 weeks, once during double-blind period | Full analysis set | Percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group79
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | EMA401 100mg BID DB | Week 4 | -1.0 | Standard Error 0.21 | scores on a scale |
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | Placebo BID DB | Week 4 | -0.8 | Standard Error 0.18 | scores on a scale |
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | EMA401 100mg BID DB | Week 8 | -1.7 | Standard Error 0.29 | scores on a scale |
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | Placebo BID DB | Week 8 | -1.1 | Standard Error 0.26 | scores on a scale |
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | EMA401 100mg BID DB | Week 12 | -1.9 | Standard Error 0.31 | scores on a scale |
| Change in Weekly Mean 24-hour Average Pain Score Using the 11 Point Numerical Rating Scale (NRS) From Baseline to Week 12 | Placebo BID DB | Week 12 | -1.3 | Standard Error 0.27 | scores on a scale |
| Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | EMA401 100mg BID DB | Week 4 | -1.2 | Standard Error 0.19 | scores on a scale |
| Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | Placebo BID DB | Week 4 | -1.0 | Standard Error 0.18 | scores on a scale |
| Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | EMA401 100mg BID DB | Week 8 | -1.3 | Standard Error 0.25 | scores on a scale |
| Change in Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 12 | Placebo BID DB | Week 8 | -0.9 | Standard Error 0.22 | scores on a scale |
1 to 10 of 79Source ClinicalTrials.gov
See all 79 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (DB) | STARTED | EMA401 100mg BID DB | 70 | |
| Double-Blind Treatment Period (DB) | STARTED | Placebo BID DB | 67 | |
| Double-Blind Treatment Period (DB) | STARTED | EMA401 100mg BID -> EMA401 100mg BID TW | 0 | |
| Double-Blind Treatment Period (DB) | STARTED | EMA401 100mg BID -> Placebo BID TW | 0 | |
| Double-Blind Treatment Period (DB) | STARTED | Placebo BID -> Placebo BID TW | 0 | |
| Double-Blind Treatment Period (DB) | COMPLETED | EMA401 100mg BID DB | 32 | |
| Double-Blind Treatment Period (DB) | COMPLETED | Placebo BID DB | 30 | |
| Double-Blind Treatment Period (DB) | COMPLETED | EMA401 100mg BID -> EMA401 100mg BID TW | 0 | |
| Double-Blind Treatment Period (DB) | COMPLETED | EMA401 100mg BID -> Placebo BID TW | 0 | |
| Double-Blind Treatment Period (DB) | COMPLETED | Placebo BID -> Placebo BID TW | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | EMA401 100mg BID DB | 0 | 69 | |
| other | Palpitations | Cardiac disorders | Placebo BID DB | 1 | 66 | |
| other | Palpitations | Cardiac disorders | EMA401 100mg BID -> EMA401 100mg BID TW | 0 | 14 | |
| other | Palpitations | Cardiac disorders | EMA401 100mg BID -> Placebo BID TW | 1 | 12 | |
| other | Palpitations | Cardiac disorders | Placebo BID -> Placebo BID TW | 0 | 26 | |
| other | Abdominal pain upper | Gastrointestinal disorders | EMA401 100mg BID DB | 5 | 69 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo BID DB | 0 | 66 | |
| other | Abdominal pain upper | Gastrointestinal disorders | EMA401 100mg BID -> EMA401 100mg BID TW | 0 | 14 | |
| other | Abdominal pain upper | Gastrointestinal disorders | EMA401 100mg BID -> Placebo BID TW | 0 | 12 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo BID -> Placebo BID TW | 0 | 26 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EMA401 100mg BID DB | 0 | 69 |
| Total, all-cause mortality | Placebo BID DB | 0 | 66 |
| Total, all-cause mortality | EMA401 100mg BID -> EMA401 100mg BID TW | 0 | 14 |
| Total, all-cause mortality | EMA401 100mg BID -> Placebo BID TW | 0 | 12 |
| Total, all-cause mortality | Placebo BID -> Placebo BID TW | 0 | 26 |
| Total, other adverse events | EMA401 100mg BID DB | 23 | 69 |
| Total, other adverse events | Placebo BID DB | 10 | 66 |
| Total, other adverse events | EMA401 100mg BID -> EMA401 100mg BID TW | 1 | 14 |
| Total, other adverse events | EMA401 100mg BID -> Placebo BID TW | 2 | 12 |
| Total, other adverse events | Placebo BID -> Placebo BID TW | 0 | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33675631 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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