Trial · NCT05917912
EASE (Efficacy of ATX01 Study in Erythromelalgia)
NCT05917912, Phase 2, Completed, AlgoTherapeutix
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EASE (Efficacy of ATX01 Study in Erythromelalgia). Trials, record NCT05917912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05917912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EASE (Efficacy of ATX01 Study in Erythromelalgia)
- NCT number
- NCT05917912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- AlgoTherapeutix
- Conditions
- Erythromelalgia
- Interventions
- Amitriptyline Hydrochloride, Placebo
- First posted
- 2023-06-26
- Last updated
- 2024-04-18
- Other registries' IDs
- eudract:2022-003804-34
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison between Treatments (ATX01 15% vs. Placebo) of mean pain attack intensity score | during the last 7 full days (Day 14 to Day 20) of each Treatment Period | Comparison between Treatments (ATX01 15% vs. Placebo) of mean pain attack intensity score assessed for the final week of each treatment period using an 11-point Numerical Pain Rating Scale (NPRS). Mean pain attack intensity is defined as the sum of the pain intensity score of each pain attack during the last 7 full days (Day 14 to Day 20) of each Treatment Period divided by the total number of erythromelalgia pain attacks during that 7-day period |
| Secondary | Mean pain attack intensity score for complete treatment period | through study completion, an average of 15 weeks | 11 point Numeric Pain Rating Scale Scale: 0-10 10 means worst possible pain |
| Secondary | Patient Global Impression of Change (PGI-C) score | through study completion, an average of 15 weeks | Patient Global Impression: Global Change (PGI-C) Scale: 1-7 7 means very much worse |
| Secondary | Change in pain interference with daily life using the Brief Pain Inventory - Short Form questionnaire (BPI-SF) | through study completion, an average of 15 weeks | Brief Pain Inventory Pain Interference Questionnaire Scale: 0-10 10 means completely interferes |
| Secondary | Change in quality of life, measured using the EuroQol-5-Dimension (EQ-5D) instrument | through study completion, an average of 15 weeks | EuroQol-5-Dimension scale |
| Secondary | Change in Beck Depression Inventory (BDI) score. | through study completion, an average of 15 weeks | BDI Scale:0-3 3 means worse |
| Secondary | Maximum pain intensity score, assessed by 11-point NPRS. | through study completion, an average of 15 weeks | 11 point Numeric Pain Rating Scale Scale: 0-10 10 means worst possible pain |
| Secondary | Mean number of pain attacks per day | through study completion, an average of 15 weeks | |
| Secondary | Mean and maximum duration of pain attacks | through study completion, an average of 15 weeks | |
| Secondary | Mean frequency of use of rescue measures (e.g., cooling). | through study completion, an average of 15 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT05917912
GET https://conductscience.org/api/trials/v1/NCT05917912/registered