Comparison · NCT03614663-53365686
ZYN002 - Cannabidiol Transdermal Gel vs Placebo Transdermal Gel: Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT03614663-53365686. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03614663-53365686
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.422 | 0.334 | 0.516 | wilson | |
| Risk in group 2 | 0.366 | 0.279 | 0.464 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0557 | -0.0758 | 0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.822 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.725 | 2.2 | log | |
| Number needed to treat, for one more participant with the outcome on ZYN002 - Cannabidiol Transdermal Gel than on Placebo Transdermal Gel | 18 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ZYN002 - Cannabidiol Transdermal Gel | ZYN002 - Cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery) | 46 | 109 | OG000 |
| Group 2 | Placebo Transdermal Gel | Placebo Transdermal Gel: Placebo formulated as a clear gel (transdermal delivery) | 37 | 101 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Improvement - Clinical Global Impressions- Improvement (CGI-I) - Full Analysis Set
- Description
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.
- Time frame
- Change in CGI-I at end of treatment (Week 12)
- Population
- The prospective comparison of the full analytical set between ZYN002 and placebo.
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)
- NCT number
- NCT03614663
- Phases
- PHASE2, PHASE3
- Conditions
- Fragile X Syndrome
- Interventions
- ZYN002 - Cannabidiol Transdermal Gel, Placebo Transdermal Gel
- Lead sponsor
- Zynerba Pharmaceuticals, Inc.
- Results first posted
- 2022-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03614663?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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