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NCT05917912 · ClinicalTrials.gov registry record · Phase 2
EASE (Efficacy of ATX01 Study in Erythromelalgia)
A Phase 2 study, sponsored by AlgoTherapeutix.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT05917912: Completed Phase 2 study, sponsored by AlgoTherapeutix.
NCT05917912 is a Phase 2 study that has completed, run by AlgoTherapeutix. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05917912, a Phase 2 study, has completed, sponsored by AlgoTherapeutix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The goal of this two-center, randomized, double-blinded, parallel-group, placebo-controlled clinical study is designed to compare the efficacy of twice daily applications of ATX01 versus placebo during two consecutive 3-week treatment periods. The primary objective is the 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. Participants will apply on feet and/or hands twice a day in the morning and in the evening, approximately 12 hours apart from the morning administration for 3 consecutive weeks each and record the pain intensity of each attack that occurs.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Amitriptyline Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-06-14 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 2 |
What the finished NCT05917912 record still lists
NCT05917912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05917912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05917912 about?
NCT05917912 is a clinical study titled "EASE (Efficacy of ATX01 Study in Erythromelalgia)". The goal of this two-center, randomized, double-blinded, parallel-group, placebo-controlled clinical study is designed to compare the efficacy of twice daily applications of ATX01 versus placebo during two consecutive 3-week treatment periods. The primary objective is the comparison between Treatmen...
What is the current status of trial NCT05917912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2023-06-14. Estimated completion is 2024-02-29.
What interventions are being tested in trial NCT05917912?
The interventions under investigation include: Placebo (DRUG), Amitriptyline Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05917912?
This trial is sponsored by AlgoTherapeutix, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05917912's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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