← 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.

Must not have

Patient is using the following AEDs (medications for the treatment of seizures and/ or epilepsy): clobazam, phenobarbital, ethosuximide, felbamate, carbamazepine, phenytoin, or vigabatrin

Any skin disease or condition including eczema, psoriasis, melanoma, acne, contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration that may affect treatment application, application site assessments or absorption of the trial drug

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

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication for seizures or epilepsy.

Select...

I do not have skin conditions that could interfere with the treatment.

Select...

I have tested positive for hepatitis B, C, or HIV.

Select...

I have tested positive for certain drugs not prescribed to me.

Select...

I do not have severe mental health issues that could affect my participation.

Select...

I have a history of serious heart problems or conditions.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, week 2, week 4, week 6, week 10, week 14, week 18 and through 4-week post-dose telephone follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 1 score in patients with complete methylation of the FMR1 gene.

Secondary study objectives

Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 2 in patients with complete methylation 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 of the FMR1 gene.

+8 more