Trial · NCT03790137
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | % Change in Frequency of Handwaving Episodes | Month 3 | One patient withdrew from the study 3 days after starting study medication. This patient developed a rash, which was not thought to be related to study medication. The patient chose not to challenge the drug at an allergists office, and instead withdrew from the study. The other 19 patients completed the core study, but only 17 provided analyzable seizure data. | % change in hand waving episodes | MEDIAN |
| PRIMARY | Change in Frequency of Generalized Tonic-clonic Seizures | Month 3 | 10 of the 20 patients reported having a generalized tonic-clonic seizure at some point in their lives. | tonic-clonic seizures/day | MEAN |
| SECONDARY | Change in Spike Frequency on EEG | Month 3 | The investigators read and interpreted pre-drug and post-drug EEGs for the first 9 patients that completed the core study. The remaining 10 patients did not undergo EEGs as part of this study, due to safety concerns during the COVID-19 pandemic. | spikes/hour | MEAN |
| SECONDARY | Number of Patients That Experienced a Photoparoxysmal Response on EEG | Month 3 | The investigators read and interpreted pre-drug and post-drug EEGs for the first 9 patients that completed the core study. The remaining 10 patients did not undergo EEGs as part of this study, due to safety concerns during the COVID-19 pandemic. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in Cognitive Functioning Determined by the Weschler Abbreviated Scale of Intelligence (WASI-II Subtests) | Month 3 (~84 days after the first dose of fenfluramine.) | 9 of the first 10 patients completed the core study. The second 10 patients did not undergo neuropsychological testing as part of this study due to safety concerns during the COVID-19 pandemic. | score on a scale | MEAN |
| SECONDARY | Changes in Cognitive Functioning Determined by the Weschler Intelligence Scale for Children (WISC-V) -Processing Speed Subtests. | Month 3 (approximately 84 days after the first dose of fenfluramine) | 9 of the first 10 patients underwent neuropsychological testing as part of the core study. The remaining patients did not undergo this testing due to safety concerns during the COVID-19 pandemic. | score on a scale | MEAN |
| SECONDARY | Changes in Quality of Life Determined by the Quality of Life in Childhood Epilepsy Questionnaire(QOLCE-16) | Month 3 (approximately 84 days after first dose of fenfluramine) | 8 of the first 9 patients completed this testing as part of the core study. The remaining patients did not undergo this testing due to safety concerns during the COVID-19 pandemic. | score on a scale | MEAN |
| SECONDARY | Changes in Executive Functioning Determined by The Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire. | Month 3 (approximately 84 days after the first dose of fenfluramine) | 7 of the first 9 patients provided pre- and post-treatment responses to the BRIEF questionnaire. The remaining patients did not undergo this testing due to safety concerns during the COVID-19 pandemic. | T Score | MEAN |
| SECONDARY | Changes in Self-Concept Determined by The Beck Self Report Inventory. | Month 3 (approximately 84 days after first dose of fenfluramine) | 7 of the first 9 patients provided pre- and post-treatment responses to the Beck Self Report Inventory. The remaining patients did not undergo this testing due to safety concerns during the COVID-19 pandemic. | T-Score | MEAN |
| SECONDARY | Changes in Anxiety Determined by the Beck Self Report Inventory | Month 3 | T score | MEAN | |
| SECONDARY | Changes in Depression Determined by the Beck Self Report Inventory | Month 3 | T score | MEAN | |
| SECONDARY | Changes in Anger Determined by the Beck Self Report Inventory | Month 3 | T score | MEAN | |
| SECONDARY | Changes in Disruptive Behavior Determined by the Beck Self Report Inventory | Month 3 | T score | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03790137/outcomes