Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)
Summary
This trial will evaluate the efficacy and safety of ZYN002, a clear cannabidiol gel that can be applied to the skin (called transdermal application) twice a day for the treatment of behavioral symptoms of Fragile X Syndrome (FXS). Eligible participants will then participate in up to a 14 week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 18 years, will be eligible to participate.
Timeline
- Start
- 2018-06-12
- Primary completion
- 2020-06-14
- Completion
- 2020-06-14
Outcome
Mixed primary results
registry analysis (superiority test); ZYN002 - Cannabidiol Transdermal Gel vs Placebo; p = 0.321; MMRM - Mixed model for repeated measures NCT03614663 ↗
registry LEAST_SQUARES_MEAN ZYN002 - Cannabidiol Transdermal Gel: -2.68 (Standard Error 0.310) change in score NCT03614663 ↗
registry analysis (superiority test); ZYN002 - Cannabidiol Transdermal Gel vs Placebo; p = 0.02; MMRM - Mixed model for repeated measures NCT03614663 ↗
registry LEAST_SQUARES_MEAN ZYN002 - Cannabidiol Transdermal Gel: -2.99 (Standard Error 0.323) Change in score NCT03614663 ↗
Publications
- Berry-Kravis E, Hagerman R, Budimirovic D, Erickson C, Heussler H, Tartaglia N, Cohen J, Tassone F, Dobbins T, Merikle E, Sebree T, Tich N, Palumbo JM, O'Quinn S. A randomized, controlled trial of ZYN002 cannabidiol transdermal gel in children and adolescents with fragile X syndrome (CONNECT-FX). J Neurodev Disord. 2022 Nov 25;14(1):56. doi: 10.1186/s11689-022-09466-6.
- Heussler HS. Emerging Therapies and challenges for individuals with Angelman syndrome. Curr Opin Psychiatry. 2021 Mar 1;34(2):123-128. doi: 10.1097/YCO.0000000000000674.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZYN002 | Unknown | 125 mg | Other |
| Subject | ZYN002 | Unknown | 250 mg | Other |