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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the long-term safety and tolerability of ZYN002 administered as a transdermal gel formulation.
Secondary study objectives
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
9%
nasopharyngitis
7%
vomiting
6%
application site pain
5%
pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ZYN002 - Cannabidiol Transdermal Gel
Placebo Transdermal Gel

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Zynerba Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
482 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
462 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
~137 spots leftby Aug 2027
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