Your session is about to expire
← Back to Search
Cannabinoid
Cannabidiol Gel for Fragile X Syndrome (RECONNECT Trial)
Phase 3
Recruiting
Research Sponsored by Zynerba Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a diagnosis of FXS through molecular documentation of full mutation of the FMR1 gene documented through genetic testing at Screening.
Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of no more than two anti-seizure medications (ASMs) for the four weeks preceding study Screening; or must be seizure-free for one year if not currently receiving ASMs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, week 2, week 4, week 6, week 10, week 14, week 18 and through 4-week post-dose telephone follow-up
Awards & highlights
RECONNECT Trial Summary
This trial is testing whether a cannabis-based drug is effective and safe in treating children and adolescents with Fragile X Syndrome.
Who is the study for?
This trial is for children, adolescents, and young adults aged 3 to less than 23 with Fragile X Syndrome. Participants must be in good health, have a stable regimen of medications if taking any, and not use cannabis products. Girls who can have babies must test negative for pregnancy.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a Cannabidiol gel (ZYN002) compared to a placebo over an 18-week period. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment or placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, typical CBD-related side effects could include drowsiness, changes in appetite or mood swings. The transdermal application may also cause skin irritation at the site of application.
RECONNECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Fragile X Syndrome through genetic testing.
Select...
I am on up to two seizure medications or have been seizure-free for a year.
Select...
I've been on a stable dose of up to 3 psychoactive medications for at least 4 weeks.
Select...
I have been diagnosed with Fragile X Syndrome through genetic testing.
Select...
I have been on a stable dose of up to three psychoactive medications for at least four weeks.
RECONNECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, week 2, week 4, week 6, week 10, week 14, week 18 and through 4-week post-dose telephone follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, week 2, week 4, week 6, week 10, week 14, week 18 and through 4-week post-dose telephone follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 1 score in patients with complete methylation (100%) of the FMR1 gene.
Secondary outcome measures
Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 2 in patients with complete methylation (100%) of the FMR1 gene.
Change in ABC-C FXS pre-specified Subscale 1 among all randomized patients (complete and partial methylation of the FMR1 gene).
Change on the Caregiver Global Impression of Change (CaGI-C) for Pre-specified parameter among patients with complete methylation (100%) of the FMR1 gene.
+8 moreRECONNECT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZYN002 - transdermal gelExperimental Treatment1 Intervention
Pharmaceutically manufactured. Cannabidiol is formulated as a clear gel for transdermal delivery.
Group II: Placebo transdermal gelPlacebo Group1 Intervention
Placebo is formulated as a clear gel for transdermal delivery.
Find a Location
Who is running the clinical trial?
Zynerba Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
682 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
662 Patients Enrolled for Fragile X Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3 and 17 years old.I've been on a stable dose of up to 3 psychoactive medications for at least 4 weeks.You answered "yes" to Question 4 or 5 on the Children's Columbia-Suicide Severity Rating Scale during screening or at any time during the study.I am taking medication for seizures or epilepsy.I am not pregnant, nursing, or planning to become pregnant and agree to use effective birth control.I have been on a stable non-drug treatment plan for at least three months.I am capable of becoming pregnant and have tested negative for pregnancy.I have been diagnosed with Fragile X Syndrome through genetic testing.I do not have skin conditions that could interfere with the treatment.I am on up to two seizure medications or have been seizure-free for a year.I am not taking any strong medications that affect liver enzymes.I, and if applicable, my caregiver, agree to follow all study rules and procedures.I have tested positive for hepatitis B, C, or HIV.I have been on a stable non-drug treatment plan for at least three months.I have been diagnosed with Fragile X Syndrome through genetic testing.Your body mass index is between 12 and 30.You have received treatment for drug abuse or have shown evidence of drug abuse in the past year.I am between 3 and 22 years old.I haven't used cannabis or any THC/CBD products in the last 3 months.I have tested positive for certain drugs not prescribed to me.My condition is severe or unstable and could affect study results.I expect to start or change treatments during the study.I haven't used any experimental drugs or devices in the last 30 days.I live on my own or in a place like a university dorm or group home.I do not have severe mental health issues that could affect my participation.You have had a strong allergic reaction to a medication similar to ZYN002.I have a history of serious heart problems or conditions.I am not taking any benzodiazepines regularly.You have not taken part in a previous ZYN002 study, except if you were screened for one study but did not enter another one afterward.Your liver enzymes (ALT, AST) or bilirubin levels are too high.I am on up to two seizure medications or have been seizure-free for a year.I have been on a stable dose of up to three psychoactive medications for at least four weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ZYN002 - transdermal gel
- Group 2: Placebo transdermal gel
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 ZYN002 - CBD transdermal gel passed FDA approval?
"ZYN002 - CBD transdermal gel is in Phase 3 of clinical trials, meaning that there is data supporting both its efficacy and safety. Our team rates it a 3 on our scale."
Answered by AI
Are investigators actively searching for participants for this research project?
"That is correct, the study is still recruiting patients. September 13th 2021 was when the trial was first posted and October 11th 2022 was when it was updated last. There are a total of 22 sites that are recruiting for this clinical trial and they need 204 patients in total."
Answered by AI
Are there specific eligibility requirements for patients who want to participate in this research?
"This study is looking for 204 participants aged 3-17 with fraxa syndrome. The most notable inclusion criteria are as follows: Male or female children and adolescents aged 3 to < 18 years, at the time of Screening., Patients have a body mass index between 12-30 kg/m2 (inclusive)., Females of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative serum or urine pregnancy test at all designated visits., Judged by the Investigator to be in generally good health at Screening based upon the results of medical history, physical exam, 12-lead ECG and clinical"
Answered by AI
Does this experiment only seek out test subjects that are over thirty?
"The age bracket for this particular clinical trial is 3-17 years old."
Answered by AI
What other research has been done on ZYN002 - CBD transdermal gel?
"As of the current moment, there are 83 ongoing clinical trials for ZYN002 - CBD transdermal gel. Of these, 18 are in Phase 3. The majority of locations running these studies are situated in Ribeirao Preto and Sao Paulo; however, there are a total of 311 sites conducting trials for this medication."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger