Your session is about to expire
← Back to Search
Flavonoid
MPFF for Post-Thrombotic Syndrome (MUFFIN-PTS Trial)
Phase 3
Waitlist Available
Led By Susan R Kahn, MD, MSc
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing age must use medically approved method of birth control and must have negative pregnancy test results at the time of randomization
Villalta score ≥5 with at least two of the following four PTS manifestations (daily heaviness, cramps, pain, and objective edema) in the leg ipsilateral to a previous objectively diagnosed DVT, or DVT of unknown date but with presence of residual proximal or distal venous obstruction on ultrasound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9 months
Awards & highlights
MUFFIN-PTS Trial Summary
This trial will test whether a daily oral supplement of MPFF can improve symptoms and quality of life for people suffering from post-thrombotic syndrome.
Who is the study for?
The MUFFIN-PTS Trial is for individuals with Post-Thrombotic Syndrome who experience symptoms like heaviness, cramps, pain, and leg swelling. Participants must be adults not on venoactive drugs recently, without severe liver or kidney disease, not pregnant or breastfeeding, and able to consent.Check my eligibility
What is being tested?
This trial tests if taking Micronized Purified Flavonoid Fraction (MPFF) daily for six months can improve symptoms and quality of life in Post-Thrombotic Syndrome patients compared to a placebo.See study design
What are the potential side effects?
Potential side effects of MPFF are generally mild but may include gastrointestinal discomfort such as upset stomach or diarrhea. Allergic reactions could occur in those sensitive to flavonoids.
MUFFIN-PTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using birth control and my pregnancy test was negative.
Select...
I have a Villalta score of 5 or more and experience daily heaviness, cramps, pain, or swelling in one leg due to a past blood clot.
MUFFIN-PTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in PTS
Cramps
General Quality of life
+16 moreMUFFIN-PTS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: VenixxaActive Control1 Intervention
Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo for 6 months
1 Tablet, BID (morning and evening) for 6 months
Find a Location
Who is running the clinical trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
21,072 Total Patients Enrolled
Susan R Kahn, MD, MScPrincipal InvestigatorJewish General Hospital (Montreal, Quebec, Canada)
Jean-Philippe Galanaud, MD, PhDPrincipal InvestigatorSunnybrook Health Sciences Centre, Toronto, Ontario, Canada
1 Previous Clinical Trials
1,300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am using birth control and my pregnancy test was negative.My liver condition is severe (Child-Pugh class C).I have changes in my mental status, either suddenly or over time.I am currently hospitalized.I have a Villalta score of 5 or more and experience daily heaviness, cramps, pain, or swelling in one leg due to a past blood clot.I haven't taken any venoactive drugs in the last 3 months.I have severe kidney disease and may be on dialysis.You have problems with drinking alcohol or using drugs.You are allergic or very sensitive to MPFF/Venixxa.I have an open sore on the same side as my vein problem.I cannot speak English or French.You are not expected to live more than one year.I have had a blood clot in my leg within the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Venixxa
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the US Food and Drug Administration given its okay to Venixxa?
"There is prior clinical data supporting Venixxa's safety, so it received a score of 3."
Answered by AI
Can patients sign up for this research project at this time?
"No, this particular clinical trial is not recruiting patients at the moment. According to the information on clinicaltrials.gov, the study was posted on October 1st 2021 and was last edited on August 9th 2021. There are many other trials (1460) that are currently looking for participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger