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Cannabinoid

Cannabidiol Gel for Fragile X Syndrome

Phase 2 & 3

Waitlist Available

Research Sponsored by Zynerba Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential must have a negative pregnancy test at all designated visits

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 month.

Awards & highlights

Study Summary

This trial is studying a manufactured form of CBD that will be applied to the skin to see if it's effective in treating epilepsy.

Who is the study for?

This trial is for children and adolescents with Fragile X Syndrome who participated in previous ZYN002 studies. They must follow study rules, provide informed consent through parents/caregivers, and females of childbearing age need a negative pregnancy test. Those with certain ongoing health issues or high liver enzyme levels can't join.Check my eligibility

What is being tested?

The trial tests the long-term safety of ZYN002, a Cannabidiol Transdermal Gel applied to the skin for those with Fragile X Syndrome. Participants will use this gel twice daily for one year to see how well they tolerate it over time.See study design

What are the potential side effects?

While specific side effects are not listed here, transdermal gels like ZYN002 could potentially cause skin irritation at the application site, allergic reactions, or systemic effects depending on absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am capable of becoming pregnant and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 month. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the long-term safety and tolerability of ZYN002 administered as a transdermal gel formulation.

Secondary outcome measures

To evaluate the long-term efficacy of ZYN002 in the treatment of symptoms of FXS.

Side effects data

From 2020 Phase 2 & 3 trial • 212 Patients • NCT03614663

14%

upper respiratory tract infection

nasopharyngitis

vomiting

application site pain

pyrexia

100%

80%

60%

40%

20%

Study treatment Arm

ZYN002 - Cannabidiol Transdermal Gel

Placebo Transdermal Gel

Trial Design

1Treatment groups

Experimental Treatment

Group I: ZYN002Experimental Treatment1 Intervention

ZYN002 - cannabidiol Transdermal Gel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zynerba Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

436 Total Patients Enrolled

2 Trials studying Fragile X Syndrome

416 Patients Enrolled for Fragile X Syndrome

Media Library

ZYN002 - Cannabidiol Transdermal Gel (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03802799 — Phase 2 & 3

Fragile X Syndrome Research Study Groups: ZYN002

Fragile X Syndrome Clinical Trial 2023: ZYN002 - Cannabidiol Transdermal Gel Highlights & Side Effects. Trial Name: NCT03802799 — Phase 2 & 3

ZYN002 - Cannabidiol Transdermal Gel (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03802799 — Phase 2 & 3

Frequently Asked Questions

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

Are there any eligibility requirements for this experiment?

"This research is only open to those who have fraxa syndrome and are between the ages of 3-18. At most, 450 participants will be accepted into this study."

Answered by AI

Can new people still enroll in this experiment?

"As of right now, this particular trial is not looking for new participants. The study was created on November 9th, 2018 and its latest update was on August 18th, 2022. If you are interested in finding other trials, there are 1446 ongoing studies for fraxa syndrome and 83 active clinical trials for ZYN002 - Cannabidiol Transdermal Gel recruiting patients at this time."

Answered by AI

Does this research project include individuals who are over 25 years old?

"This study is only looking for participants aged 3-18. Out of the 1480 total clinical trials, 397 studies focus on pediatrics while 1083 are for geriatrics."

Answered by AI

Are there similar ongoing studies to ZYN002 - Cannabidiol Transdermal Gel?

"ZYN002 - Cannabidiol Transdermal Gel was first studied in the year 2012 at Davidof Cancer Center, Beilinson hospital, Rabin medical center. Since then there have been 120 completed trials. There are presently 83 active studies, with many of these trials taking place in Cleveland, Ohio."

Answered by AI

How many study sites are there for this trial?

"Currently, there are 18 sites enrolling patients for this trial. To help reduce the travel burden for participants, study locations have been selected in major cities including Cleveland, New york and Tulsa among others."

Answered by AI