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Tricyclic Antidepressant
Amitriptyline for Erythromelalgia (EASE Trial)
Phase 2
Waitlist Available
Research Sponsored by AlgoTherapeutix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of erythromelalgia, as characterized by redness, warmth, and burning pain of the extremities (most commonly feet), typically precipitated by heat or exercise and relieved by cooling
Mean pain attack intensity, measured on the 11-point NPRS, of ≥4 and ≤9 at baseline and ≥4 pain attacks per week as documented through eDiary use during the 3 weeks prior to randomization (Day -21 to Day -1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the last 7 full days (day 14 to day 20) of each treatment period
Awards & highlights
EASE Trial Summary
This trial will compare 2 treatments for reducing pain intensity from foot/hand attacks in participants over two 3-week periods. Participants will apply the treatments twice a day and record the pain intensity of each attack.
Who is the study for?
Adults with erythromelalgia, experiencing redness, warmth, and burning pain in extremities triggered by heat or exercise. They must have a documented diagnosis, an average pain intensity of 4-9 on the NPRS scale, at least four attacks per week, stable medication doses for four weeks prior to the study (except topical agents), and agree to contraception if applicable.Check my eligibility
What is being tested?
The EASE trial is testing ATX01 (Amitriptyline Hydrochloride) cream against a placebo. Participants will apply it twice daily to their feet/hands over two 3-week periods while tracking pain attack intensity using an eDiary. The main goal is to see if ATX01 reduces the severity of pain attacks more effectively than a placebo.See study design
What are the potential side effects?
Potential side effects include those commonly associated with amitriptyline such as drowsiness, dry mouth, blurred vision, constipation and urinary retention. Since this is a topical application, systemic side effects may be less common but can still occur.
EASE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have erythromelalgia, with symptoms like redness, warmth, and pain in my feet or hands that worsen with heat or exercise.
Select...
My average pain level is between 4 and 9, and I've had at least 4 pain attacks each week for the last 3 weeks.
Select...
I am not pregnant and will use or am using effective birth control, or I am surgically sterilized or have been menopausal for at least 1 year.
EASE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the last 7 full days (day 14 to day 20) of each treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the last 7 full days (day 14 to day 20) of each treatment period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison between Treatments (ATX01 15% vs. Placebo) of mean pain attack intensity score
Secondary outcome measures
Change in Beck Depression Inventory (BDI) score.
Change in pain interference with daily life using the Brief Pain Inventory - Short Form questionnaire (BPI-SF)
Change in pain score before and after rescue measures (e.g., cooling).
+8 moreEASE Trial Design
2Treatment groups
Active Control
Group I: Sequence AActive Control2 Interventions
i)screening and randomization; ii) baseline period (3 weeks); iii) treatment period 1 with placebo(3 weeks); iv) wash-out period (3 weeks); v), treatment period 2 with ATX-01(3 weeks); vi) follow-up visit
Group II: Sequence BActive Control2 Interventions
i)screening and randomization; ii) baseline period (3 weeks); iii) treatment period 1 with ATX-01(3 weeks); iv) wash-out period (3 weeks); v), treatment period 2 with placebo (3 weeks); vi) follow-up visit
Find a Location
Who is running the clinical trial?
AlgoTherapeutixLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor thinks the patient may be at risk of hurting themselves, based on a talk with the patient and a special scale used to check for this.I am taking more than 2 painkillers from different classes along with the study drug.I haven't used any medical creams on my arms or legs, except for cosmetic reasons, in the last 12 weeks.The doctor thinks starting the experimental treatment might be risky for you because of certain health conditions, such as hyperthyroidism, convulsive disorder, advanced liver disease, pyloric stenosis, or paralytic ileus.My medication doses have been stable for 4 weeks and will remain the same during the study.I agree to use two forms of birth control if I'm sexually active with a woman who can have children, and not to donate sperm for 90 days after my last dose.I have a diagnosed pain condition in my limbs not caused by erythromelalgia.I have a history of heart artery disease.My average pain level is between 4 and 9, and I've had at least 4 pain attacks each week for the last 3 weeks.I am not pregnant and will use or am using effective birth control, or I am surgically sterilized or have been menopausal for at least 1 year.I haven't taken any monoamine oxidase inhibitors in the last 24 weeks.I have glaucoma.You are allergic to amitriptyline in any form or to any ingredient in the topical cream.I cannot apply medication to my own hands or feet.I have had or currently have major depression.I have skin issues and swelling in my limbs.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).You have used illegal drugs or have been confirmed to use drugs that are not prescribed by a doctor. If you have a positive urine test for prescribed medication, the doctor can decide if you can still participate.I have trouble emptying my bladder or have a significantly enlarged prostate.Your electrocardiogram (ECG) shows a certain abnormality that makes it risky for you to take part in the study, like having a prolonged QT interval.I haven't taken any medications in the last 24 weeks that affect my heart's rhythm.I have not taken amitriptyline, nortriptyline, or any tricyclic antidepressant in the last 4 weeks.I haven't taken glutathione, vitamin E, minocycline, or calcium magnesium supplements in the last 12 weeks.I haven't used any skin-applied pain treatments recently.I have an implanted device for pain management.I have not had a regional anesthetic block for pain in the last 3 months.I haven't taken any drugs that affect liver enzyme CYP2D6 in the last month.My body processes some medications slowly.I have erythromelalgia, with symptoms like redness, warmth, and pain in my feet or hands that worsen with heat or exercise.I haven't used opioids in the last 4 weeks or during the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence A
- Group 2: Sequence B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for this clinical investigation?
"According to the details available at clinicaltrials.gov, this trial is not recruiting participants currently. Initially posted on June 14th 2023 and last updated that same day, there are two other trials actively enrolling patients instead."
Answered by AI
To what extent can Sequence A be detrimental to human health?
"As a Phase 2 trial, there is some evidence of safety for Sequence A and thus our team assigned it an evaluation score of two. Unfortunately, efficacy data for this drug has yet to be provided."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
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