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NCT04977986 (ZYN002 in Fragile X Syndrome): BVCT ex-ante prediction vs. reported outcome

On 26 Jan 2025, BioinvestGPT's BVCT predicted technical partial success and commercial success for this trial. The 24 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04977986
Acronym
RECONNECT
Drug Name
ZYN002
Drug MoA
cannabidiol gel
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Fragile X Syndrome
Human Patients
215
Sponsor
Harmony Biosciences
Phase
Phase 3

Prediction of , index 1886

Prospective Prediction
Prediction Index
1886
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient yet weak clinical benefit in ABC-C FXS only for patients with complete FMR1 methylation due to no FDA approved drug on the market)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ABC-C FXS only for patients with complete FMR1 methylation)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
241 days in advance
Readout Data Interpretation
ZYN002 failed to meet the primary efficacy endpoint compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents and Young Adults With Fragile X Syndrome - RECONNECT
Phase
Phase 3
Status
Completed
Enrollment
257
Lead sponsor
Harmony Biosciences Management, Inc.
Conditions
Fragile X Syndrome; Fragile X Syndrome (FXS)
Interventions
DRUG: ZYN002; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-09-13
Primary completion
2025-08-29
Completion
2025-08-29
Primary outcomes
  • 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. (Change from Baseline to Week 18)

NCT04977986 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials