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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 is a Phase 2 study that has completed, run by AlgoTherapeutix. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05917912
The ClinicalTrials.gov registry entry for NCT05917912 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AlgoTherapeutix, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05917912 reports 0 study locations.
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.
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