Trial · NCT03094195
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
NCT03094195, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN). Trials, record NCT03094195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03094195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
- NCT number
- NCT03094195
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Post-herpetic Neuralgia
- Interventions
- EMA401, Placebo
- First posted
- 2017-03-29
- Last updated
- 2021-10-08
- Results first posted
- 2020-05-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-response in Change in Weekly Mean of the 24-hour Average Pain Score, Using an 11-point Numeric Rating Scale (NRS), From Baseline to Week 12 | Baseline up to Week 12 | 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. |
| Secondary | 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 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 numeric rating scale (NRS) with zero being "does not interfere" and ten being "completely interferes". A reduction in mean indicates improvement |
| 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% /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 | 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. 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. |
| 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 | Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12 | Week 8, Week 12 | 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-response in Change in Weekly Mean of the 24-hour Average Pain Score, Using an 11-point Numeric Rating Scale (NRS), From Baseline to Week 12 | Baseline up to Week 12 | Due to premature study termination 300 mg BID dose was not initiated | ||
| SECONDARY | 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 | number of patients with observed change from baseline on respective visit. | 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 numeric rating 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 | 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 | Plasma Pharmacokinetics (PK) Concentrations at Week 8 and 12 | Week 8, Week 12 | PK analysis set | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group96
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 25mg BID DB | Week 4 | -0.4 | Standard Error 0.23 | 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 4 | -0.9 | Standard Error 0.25 | 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 | -0.5 | Standard Error 0.23 | 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 25mg BID DB | Week 8 | -1.0 | 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 | EMA401 100mg BID DB | Week 8 | -1.0 | 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 | -0.7 | Standard Error 0.30 | 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 25mg BID DB | Week 12 | -0.9 | Standard Error 0.40 | 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 | -1.2 | Standard Error 0.38 | 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 | -0.7 | Standard Error 0.40 | scores on a scale |
| Change in Brief Pain Inventory-Short Form Interference (BPI-SF) Mean Total Score From Baseline to Week 12 | EMA401 25mg BID DB | -8.24 | Standard Deviation 12.994 | scores on a numeric rating scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (DB) | STARTED | EMA401 25mg BID DB | 43 | |
| Double-Blind Treatment Period (DB) | STARTED | EMA401 100mg BID DB | 43 | |
| Double-Blind Treatment Period (DB) | STARTED | Placebo BID DB | 43 | |
| Double-Blind Treatment Period (DB) | STARTED | EMA401 25mg BID -> EMA401 25mg BID TW | 0 | |
| Double-Blind Treatment Period (DB) | STARTED | EMA401 25mg BID -> Placebo BID TW | 0 | |
| 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 25mg BID DB | 28 | |
| Double-Blind Treatment Period (DB) | COMPLETED | EMA401 100mg BID DB | 30 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events160
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 | Diarrhoea | Gastrointestinal disorders | EMA401 25 mg b.i.d. | 3 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | EMA401 100 mg b.i.d. | 2 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo b.i.d. | 3 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d. | 0 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | EMA401 25 mg b.i.d. - Placebo b.i.d. | 0 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d. | 0 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | EMA401 100 mg b.i.d. - Placebo b.i.d. | 0 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo b.i.d. - Placebo b.i.d. | 0 | 26 | |
| other | Dyspepsia | Gastrointestinal disorders | EMA401 25 mg b.i.d. | 0 | 43 | |
| other | Dyspepsia | Gastrointestinal disorders | EMA401 100 mg b.i.d. | 3 | 43 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EMA401 25 mg b.i.d. | 0 | 43 |
| Total, all-cause mortality | EMA401 100 mg b.i.d. | 0 | 43 |
| Total, all-cause mortality | Placebo b.i.d. | 0 | 43 |
| Total, all-cause mortality | EMA401 25 mg b.i.d. - EMA401 25 mg b.i.d. | 0 | 13 |
| Total, all-cause mortality | EMA401 25 mg b.i.d. - Placebo b.i.d. | 0 | 13 |
| Total, all-cause mortality | EMA401 100 mg b.i.d. - EMA401 100 mg b.i.d. | 0 | 15 |
| Total, all-cause mortality | EMA401 100 mg b.i.d. - Placebo b.i.d. | 0 | 13 |
| Total, all-cause mortality | Placebo b.i.d. - Placebo b.i.d. | 0 | 26 |
| Total, other adverse events | EMA401 25 mg b.i.d. | 8 | 43 |
| Total, other adverse events | EMA401 100 mg b.i.d. | 12 | 43 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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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