Trial · NCT02435199
Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
NCT02435199, Phase 2, Withdrawn, Spinifex Pharmaceuticals Pty Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy. Trials, record NCT02435199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02435199
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy
- NCT number
- NCT02435199
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Spinifex Pharmaceuticals Pty Ltd
- Conditions
- Diabetic Neuropathies
- Interventions
- EMA401 600mg, Placebo
- First posted
- 2015-05-06
- Last updated
- 2015-08-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN), as assessed by the difference in the weekly mean of the 24 hour average pain score, using an 11-point Numeric Rating Scale (NRS). | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo on the BPI-SF interference total score. | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score. | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo, on the Patient Global Impression of Change (PGIC). | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) average pain score. | Change from Baseline to Week 12 | |
| Secondary | The proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean 24 hour average pain score compared to placebo (i.e., responder rates). | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo on the Neuropathic Pain Symptom Inventory (NPSI). | Change from Baseline to Week 12 | |
| Secondary | The effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI). | Change from Baseline to Week 12 | |
| Secondary | The safety and tolerability of EMA401 in patients with PDN as measured by number and severity of adverse events. | Change from Baseline to Week 12 |
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/NCT02435199
GET https://conductscience.org/api/trials/v1/NCT02435199/registered