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Anti-inflammatory

Acebilustat for Arm Lymphedema (HEAL Trial)

Phase 2
Recruiting
Led By Stanley Rockson, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 18-75
Upper arm lymphedema, single arm, stage 2, greater than 6 months duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 36
Awards & highlights

HEAL Trial Summary

This trial is testing a new drug to see if it can help people with arm lymphedema. For 3 months, participants will take a placebo pill, and for 6 months they will take the active drug. The study is blind, so participants won't know which pill they're taking.

Who is the study for?
This trial is for adults aged 18-75 with stage 2 upper arm lymphedema lasting over 6 months. Participants must have completed lymphedema therapy at least 8 weeks prior, be vaccinated against COVID-19, and use compression garments. They can't join if they have clotting disorders, chronic infections in the limb, kidney or liver disease, are pregnant/nursing, have a history of substance abuse within the last six months or are on certain medications like statins.Check my eligibility
What is being tested?
The study tests Acebilustat's effectiveness for treating unilateral upper extremity lymphedema compared to a placebo. Over nine months, participants will unknowingly receive either Acebilustat or a placebo for different durations (placebo for three months and Acebilustat for six).See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical drug reactions such as gastrointestinal issues, allergic responses or skin rashes. Since it's an oral medication being tested against a placebo without active ingredients, some participants might not experience any side effects.

HEAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
I have had stage 2 lymphedema in one arm for over 6 months.
Select...
I have received a Covid-19 vaccine (Pfizer, Moderna, or Johnson & Johnson).

HEAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in ultrasonographic measurement of dermal thickness in the affected upper extremity
Secondary outcome measures
Change from baseline in caliper measurement of dermal thickness in the affected upper extremity

Side effects data

From 2023 Phase 2 trial • 120 Patients • NCT04662060
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Acebilustat

HEAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Placebo and acebilustatExperimental Treatment2 Interventions
Participants will take acebilustat and placebo over a period of 9 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acebilustat
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,280 Total Patients Enrolled
13 Trials studying Lymphedema
6,502 Patients Enrolled for Lymphedema
Celltaxis LLCUNKNOWN
Stanley Rockson, MDPrincipal InvestigatorStanford University

Media Library

Acebilustat (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT05203835 — Phase 2
Lymphedema Research Study Groups: Placebo and acebilustat
Lymphedema Clinical Trial 2023: Acebilustat Highlights & Side Effects. Trial Name: NCT05203835 — Phase 2
Acebilustat (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05203835 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria for this medical trial?

"This trial is seeking 70 individuals aged 18-75 with lymphedema. To be eligible, applicants must: possess a gender, have received the Covid-19 vaccine (Pfizer, Moderna or Johnson & Johnson), comprehend and sign an informed consent document, endure single arm upper arm lymphedema of stage 2 for over 6 months duration, wear appropriate compression garments during the daytime hours while participating in self-care activities from screening to completion of the research study; additionally if any surgical treatment has been given at least one year should pass before being screened as well as finishing their course of lymphatic therapy 8 weeks prior to"

Answered by AI

What risks accompany the utilization of Acebilustat?

"Our team at Power assigned Acebilustat a score of 2 on our safety scale, as the drug has only been tested in Phase 2 trials without any conclusive evidence for its efficacy."

Answered by AI

Is this research project welcoming individuals more than half a century of age to participate?

"This medical study is only open to individuals aged between 18 and 75. However, there are additional trials for children younger than 18 and elderly persons above the age of 65."

Answered by AI

Are there any open spots available in this research endeavor?

"Affirmative, clinicaltrials.gov data suggests that this trial is currently recruiting patients. Posted on July 27th 2022 and most recently edited August 4th 2022, the study aims to recruit 70 participants from a single medical centre."

Answered by AI

What is the overall enrollment rate of participants in this trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research project, which was initially posted on July 27th 2022, is still actively recruiting participants. Approximately 70 individuals are required to be recruited from 1 medical site."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Colorado
How old are they?
65+
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trial of Acebilustat for the Treatment of Upper Arm Lymphedema
Stanley Rockson 2022. "Trial of Acebilustat for the Treatment of Upper Arm Lymphedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203835.
All > Lymphedema
~23 spots leftby Feb 2025
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