Trial · NCT05064878
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 57
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change from Baseline in Countable Motor Seizure Frequency (CMSF) (Part 1) | Baseline (28 days), Combined Titration and Maintenance (T+M) Periods (14 weeks) | The median percentage change from the Baseline in monthly (per 28 days) CMSF during the combined Titration and Maintenance Periods with the fenfluramine (ZX008) 0.8 mg/kg/day group compared with the placebo group will be reported. |
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 2) | Up to OLE1 Treatment Period Post-Dose Safety Follow-up Visit 17 (up to 70 weeks) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment Emergent Adverse Events (TEAEs) are defined as any AEs reported on or after the first dose of study medication. |
| Primary | Percentage of Participants With Abnormal Physical Examination Findings (Part 2) | Up to End of Treatment (EoT)/Early Termination (ET) Visit 16 of OLE1 Treatment Period (up to 68 weeks) | Abnormal findings of physical exam that is considered clinically significant by Principal Investigator (PI). |
| Primary | Percentage of Participants With Abnormal Neurological Examination Findings (Part 2) | Up to EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | Abnormal findings of neurological exam that is considered clinically significant by PI. |
| Primary | Percentage of Participants with Positive Response to Self-harm Question (Part 2) | OLE1 Treatment Period Day 1 to OLE1 Treatment Period Post-Dose Safety Follow-up Visit 17 (up to 70 weeks) | |
| Primary | Percentage of Participants with Increase in Valvular Regurgitation from Baseline (except absent to trace) (Part 2) | Baseline (28 days), Cardiac Follow-up Visit 18 (up to 96 weeks) | Valvular regurgitation will be assessed using a 2-dimensional (2-D) Color Doppler Echocardiography (ECHO). |
| Primary | Percentage of Participants with Pulmonary Arterial Hypertension (PASP > 35 mmHg) at any Time During Treatment on Repeat Testing (Part 2) | OLE1 Treatment Period Day 1 to EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory Parameters (Hematology) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory Parameters (Hormones) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory parameters (Chemistry) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Laboratory Parameters (Urinalysis) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Vital Signs (Blood pressure) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Vital Signs (Heart rate) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Vital Signs (Temperature) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Vital Signs (Respiratory rate) (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Body Weight (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Change from Baseline in Tanner Staging (Part 2) | Baseline (28 days), EoT/ET Visit 16 of OLE1 Treatment Period (up to 68 weeks) | |
| Primary | Percentage of Participants with TEAEs (Part 3) | Up to OLE2 Period Post-Dose Safety Follow-up (up to 200 weeks) | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment Emergent Adverse Events are defined as any AEs reported on or after the first dose of study medication. |
| Primary | Change from Baseline in Height (Part 3) | Baseline (28 days), OLE2 Period EoT/ET Visit 23 (up to 198 weeks) | |
| Primary | Change from Baseline in Body Weight (Part 3) | Baseline (28 days), OLE2 Period EoT/ET Visit 23 (up to 198 weeks) |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05064878/registered