Trial · NCT02426411
Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN
NCT02426411, Phase 2, Withdrawn, Spinifex Pharmaceuticals Pty Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN. Trials, record NCT02426411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02426411
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN
- NCT number
- NCT02426411
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Spinifex Pharmaceuticals Pty Ltd
- Conditions
- Neuralgia, Postherpetic
- Interventions
- EMA401 200 mg, EMA401 600 mg, Placebo
- First posted
- 2015-04-24
- Last updated
- 2015-08-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the efficacy of two dose levels of EMA401 compared to placebo in patients with postherpetic neuralgia (PHN), as assessed by the change in the weekly mean of the 24 hour average pain score using an 11-point Numerical Rating Scale (NRS) | Baseline to approximately Week 14 | |
| Secondary | To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score | Baseline to approximately Week 14 | |
| Secondary | To evaluate the effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score | Baseline to approximately Week 14 | |
| Secondary | To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC) | Baseline to approximately Week 14 | |
| Secondary | To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain | Baseline to approximately Week 14 | |
| Secondary | To determine the proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean pain of the 24 hour average score (NRS) compared to placebo (i.e., responder rates) | Baseline to approximately Week 14 | |
| Secondary | To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI) | Baseline to approximately Week 14 | |
| Secondary | To evaluate the safety and tolerability of EMA401 in patients with PHN as measured by adverse events, vital signs, and laboratory results | Baseline to approximately Week 14 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02426411
GET https://conductscience.org/api/trials/v1/NCT02426411/registered