Trial · NCT03355209
Outcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 45
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in the Combined Titration and Maintenance Period (T+M) in the ZX008 0.8 mg/kg/Day Group Compared to the Placebo Group | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The Modified Intent-to-Treat (mITT) Population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percent change | MEDIAN |
| PRIMARY | Part 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Part 2 Baseline until end of the OLE Period (up to 72 months) | The OLE Safety Population included all participants who received at least 1 dose of ZX008 during the OLE. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported. | percentage of participants | NUMBER |
| PRIMARY | Part 2: Percentage of Participants With Serious TEAEs | From Part 2 Baseline until end of the OLE Period (up to 72 months) | The OLE Safety Population included all participants who received at least 1 dose of ZX008 during the OLE. As pre-specified in study design, participants in Part 2 received individualized optimized treatment (0.2 mg/kg/day to 0.8 mg/kg/day) based on Investigator discretion. Hence overall data for Part 2 is reported. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC-confirmed) in T+M in the ZX008 0.2 mg/kg/Day Group Compared to the Placebo Group | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percent change | MEDIAN |
| SECONDARY | Part 1: Percentage of Participants Who Achieve a >=50% Reduction From Baseline in the Frequency of Seizures That Result in Drops Comparing the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Who Achieve Improvement (Minimally, Much or Very Much Improved) in the CGI-I Scale as Assessed by Principal Investigator Comparing ZX008 0.8 and 0.2 mg/kg/Day Groups Independently Versus Placebo | At Day 99 (Visit 12) | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percent Change From Baseline in Frequency of All Seizures That Typically Result in Drops in T+M, Whether ESC-confirmed as Drop or Not in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percent change | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percent change | MEDIAN |
| SECONDARY | Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | seizure frequency per 28 days | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in T+M in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. | percent change | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of Seizures That Result in Drops (ESC Confirmed) Between Baseline and the Maintenance Period | During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percent change | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of Seizures That Typically Result in Drops in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | During Maintenance Period (12 weeks), compared to Baseline | The mITT Population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percent change | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of All Countable Motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percent change | MEDIAN |
| SECONDARY | Part 1: Change From Baseline in the Frequency of All Countable Non-motor Seizures in the Maintenance Period in the ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | seizure frequency per 28 days | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in the Frequency of All Countable Seizures (Motor and Non-motor) in the Maintenance Period in ZX008 0.8 mg/kg/Day and 0.2 mg/kg/Day Groups Independently Versus Placebo | During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percent change | MEDIAN |
| SECONDARY | Part 1: Percent Change From Baseline in Frequency of Countable Seizures That do Not Result in Drops (ESC Confirmed) | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)] | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. | percent change | MEDIAN |
| SECONDARY | Part 1: Percentage of Participants Who Achieved a Worsening From Baseline (ie <=0% Reduction), or >0, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Result in Drops | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, Number Analyzed included those participants who were evaluable at specified time point. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Seizures That Typically Results in Drops | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number analyzed included those participants who were evaluable at specified time point. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in All Countable Motor Seizures | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number analyzed included those participants who were evaluable at specified time point. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Percentage of Participants Who Achieved a Worsening From Baseline, or >0%, >=25%, >=50%, >=75%, 100% Reduction, and Near Seizure Freedom Between Baseline and T+M, and Baseline and M, in Countable Motor Seizures That do Not Result in Drops | From Baseline up to 14 weeks [Titration Period (2 weeks) + Maintenance Period (12 weeks)]; During Maintenance Period (12 weeks), compared to Baseline | The mITT population included all randomized participants who received at least 1 dose of ZX008 or placebo and for whom at least 1 week of diary data were available. Here, number of participants analyzed included those participants who were evaluable for the assessment. Number analyzed included those participants who were evaluable at specified time point. | percentage of participants | NUMBER |
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.
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