Trial · NCT03094195
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| SECONDARY | Exposure-response (Decrease in Pain Intensity) Via Evaluation of Effect of EMA401 Exposure on Efficacy Variables (e.g. Change From Baseline of Pain Score), Via Descriptive Pharmacokinetics/ Pharmacodynamics (PK/PD) | Baseline, Week 8, Week 12 | Analysis was not performed | ||
| SECONDARY | Treatment Emergent Adverse Events During Urgent Safety Measure (USM) Follow-Up | Approximately from 3 weeks after end of study up to 16 weeks | The Overall Number of Participants Analyzed reflects the Safety population, regardless of whether they completed the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03094195/outcomes