Comparison · NCT04007991-sae
Ecopipam HCI 2 mg/kg/Day vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Ecopipam HCI 2 mg/kg/Day vs Placebo: serious adverse events. Trial comparisons, record NCT04007991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04007991-sae
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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 | 0.0263 | 0.00725 | 0.091 | wilson | |
| Risk in group 2 | 0.013 | 0.0023 | 0.07 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0133 | -0.0468 | 0.0789 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.03 | 0.188 | 21.9 | log | |
| Odds ratio, group 1 over group 2 | 2.05 | 0.182 | 23.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ecopipam HCI 2 mg/kg/Day than on Placebo | 75 | 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 | Ecopipam HCI 2 mg/kg/Day | Participants received a targeted steady-state dose of 2 milligram per kilogram per day (mg/kg/day) of ecopipam HCl tablets orally, once daily during a titration and treatment period for a total of 12 weeks. | 2 | 76 | EG000 |
| Group 2 | Placebo | Participants received matching placebo tablets orally, once daily during a titration and treatment period for a total of 12 weeks. | 1 | 77 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Screening up to 30 days after the last dose ( up to Week 16)
Source ClinicalTrials.gov
Trial
- Title
- Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
- NCT number
- NCT04007991
- Phases
- PHASE2
- Conditions
- Tourette Syndrome
- Interventions
- Ecopipam, Placebo
- Lead sponsor
- Emalex Biosciences Inc.
- Results first posted
- 2023-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04007991?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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