Trial · NCT03614663
Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)
NCT03614663, Phase 2, Phase 3, Completed, Zynerba Pharmaceuticals, Inc.; results first posted 2022-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX). Trials, record NCT03614663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03614663
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)
- NCT number
- NCT03614663
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- Zynerba Pharmaceuticals, Inc.
- Conditions
- Fragile X Syndrome
- Interventions
- ZYN002 - Cannabidiol Transdermal Gel, Placebo Transdermal Gel
- First posted
- 2018-08-03
- Last updated
- 2022-07-06
- Results first posted
- 2022-06-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set | Change from Baseline to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 12, and a higher value indicates a worse outcome. |
| Primary | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis | Change from baseline to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 12, and the higher score means a worse outcome. |
| Secondary | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set | Change from baseline to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is between 0 and 54, and the higher score means a worse outcome. |
| Secondary | Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set | Change from baseline to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 and 39, and a higher mean indicates a worse outcome. |
| Secondary | Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set | Change in CGI-I at end of treatment (Week 12) | The Clinical Global Impressions- Improvement global improvement item is a 7-point Likert scale designed to measure behavioral symptomatic change at a specific time compared to baseline. CGI-I is a standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities. The score ranges form 1-very much improved to 7-very much worse. The percentage of patients with any improvement (minimally, much, very much improved) was assessed. |
| Secondary | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Ad Hoc Analysis | Change from baseline in ABC-C to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is between 0 and 54, and the higher score means a worse outcome. |
| Secondary | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Ad Hoc Analysis | Change from baseline in ABC-C to end of treatment (Week 12) | The Aberrant Behavior Checklist-Community is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The range for score for the subscale is from 0 to 39 , and the higher score means a worse outcome. |
| Secondary | Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Ad Hoc Analysis | Change in CGI-I at end of treatment (Week 12) | The Clinical Global Impressions- Improvement global improvement item is a 7-point Likert scale designed to measure behavioral symptomatic change at a specific time compared to baseline. CGI-I is a standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities. The score ranges form 1-very much improved to 7-very much worse. The percentage of patients with any improvement (minimally, much, very much improved) was assessed. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set | Change from Baseline to end of treatment (Week 12) | The prospective comparison of the full analytical set between ZYN002 and placebo. | change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set | Change from baseline to end of treatment (Week 12) | The prospective comparison of the full analytical set between ZYN002 and placebo. | Change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set | Change from baseline to end of treatment (Week 12) | The prospective comparison of the full analytical set between ZYN002 and placebo. | Change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set | Change in CGI-I at end of treatment (Week 12) | The prospective comparison of the full analytical set between ZYN002 and placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis | Change from baseline to end of treatment (Week 12) | A pre-specified, ad hoc analysis of the data collected in patients with ≥90% methylation of the FMR1 gene to evaluate the effect of ZYN002 versus placebo was developed prior to unblinding the trial. | Change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Ad Hoc Analysis | Change from baseline in ABC-C to end of treatment (Week 12) | A pre-specified, ad hoc analysis of the data collected in patients with ≥90% methylation of the FMR1 gene to evaluate the effect of ZYN002 versus placebo was developed prior to unblinding the trial. | Change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Ad Hoc Analysis | Change from baseline in ABC-C to end of treatment (Week 12) | A pre-specified, ad hoc analysis of the data collected in patients with ≥90% methylation of the FMR1 gene to evaluate the effect of ZYN002 versus placebo was developed prior to unblinding the trial. | Change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Ad Hoc Analysis | Change in CGI-I at end of treatment (Week 12) | A pre-specified, ad hoc analysis of the data collected in patients with ≥90% methylation of the FMR1 gene to evaluate the effect of ZYN002 versus placebo was developed prior to unblinding the trial. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set | ZYN002 - Cannabidiol Transdermal Gel | -2.68 | Standard Error 0.310 | change in score | |
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set | Placebo | -2.29 | Standard Error 0.318 | change in score | |
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set | ZYN002 - Cannabidiol Transdermal Gel | -5.88 | Standard Error 0.960 | Change in score | |
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Irritability Subscale - Full Analysis Set | Placebo Transdermal Gel | -4.14 | Standard Error 0.984 | Change in score | |
| Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set | ZYN002 - Cannabidiol Transdermal Gel | -3.50 | Standard Error 0.565 | Change in score | |
| Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Socially Unresponsive/Lethargic Subscale - Full Analysis Set | Placebo Transdermal Gel | -3.14 | Standard Error 0.577 | Change in score | |
| Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set | ZYN002 - Cannabidiol Transdermal Gel | 46 | Participants | ||
| Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set | Placebo Transdermal Gel | 37 | Participants | ||
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis | ZYN002 - Cannabidiol Transdermal Gel | -2.99 | Standard Error 0.323 | Change in score | |
| Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Ad Hoc Analysis | Placebo | -1.99 | Standard Error 0.345 | Change in score |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZYN002 - Cannabidiol Transdermal Gel | 110 | |
| Overall Study | STARTED | Placebo Transdermal Gel | 102 | |
| Overall Study | COMPLETED | ZYN002 - Cannabidiol Transdermal Gel | 106 | |
| Overall Study | COMPLETED | Placebo Transdermal Gel | 99 | |
| Overall Study | NOT COMPLETED | ZYN002 - Cannabidiol Transdermal Gel | 4 | |
| Overall Study | NOT COMPLETED | Placebo Transdermal Gel | 3 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | vomiting | Gastrointestinal disorders | ZYN002 - Cannabidiol Transdermal Gel | 8 | 109 | 9 |
| other | vomiting | Gastrointestinal disorders | Placebo Transdermal Gel | 6 | 102 | 7 |
| other | pyrexia | General disorders | ZYN002 - Cannabidiol Transdermal Gel | 5 | 109 | 5 |
| other | pyrexia | General disorders | Placebo Transdermal Gel | 7 | 102 | 7 |
| other | application site pain | General disorders | ZYN002 - Cannabidiol Transdermal Gel | 7 | 109 | 7 |
| other | application site pain | General disorders | Placebo Transdermal Gel | 1 | 102 | 1 |
| other | upper respiratory tract infection | Infections and infestations | ZYN002 - Cannabidiol Transdermal Gel | 15 | 109 | 16 |
| other | upper respiratory tract infection | Infections and infestations | Placebo Transdermal Gel | 7 | 102 | 7 |
| other | nasopharyngitis | Infections and infestations | ZYN002 - Cannabidiol Transdermal Gel | 10 | 109 | 10 |
| other | nasopharyngitis | Infections and infestations | Placebo Transdermal Gel | 9 | 102 | 9 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZYN002 - Cannabidiol Transdermal Gel | 0 | 109 |
| Total, all-cause mortality | Placebo Transdermal Gel | 0 | 102 |
| Total, other adverse events | ZYN002 - Cannabidiol Transdermal Gel | 45 | 109 |
| Total, other adverse events | Placebo Transdermal Gel | 30 | 102 |
| Total, serious adverse events | ZYN002 - Cannabidiol Transdermal Gel | 0 | 109 |
| Total, serious adverse events | Placebo Transdermal Gel | 0 | 102 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ZYN002 - Cannabidiol Transdermal Gel vs Placebo Transdermal Gel: Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Ad Hoc Analysis | Trial comparisons |
| ZYN002 - Cannabidiol Transdermal Gel vs Placebo Transdermal Gel: Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set | Trial comparisons |
| ZYN002 - Cannabidiol Transdermal Gel vs Placebo Transdermal Gel: deaths from any cause | Trial comparisons |
| ZYN002 - Cannabidiol Transdermal Gel vs Placebo Transdermal Gel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03614663
GET https://conductscience.org/api/trials/v1/NCT03614663/registered