Trial · NCT02953548
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | From signing of informed consent up to Day 15 | TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. |
| Primary | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Day 4 and Day 15 | |
| Primary | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Day 4 and Day 15 | |
| Primary | Number of Participant With Any Clinically Relevant Urinalysis Parameter Value | Day 4 and Day 15 | Clinical relevance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Electrocardiogram Findings | From signing of informed consent up to Day 15 | Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | From signing of informed consent up to Day 15 | Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Vital Sign Findings | From signing of informed consent up to Day 15 | Clinical significance was determined by the investigator. |
| Secondary | Number of Participants Free of Clinical Spasms | Day 15 | Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Participants Free of Clinical Spasms | Day 15 | Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Number of Participants With Resolution of Hypsarrhythmia | Day 15 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Participants With Resolution of Hypsarrhythmia | Day 15 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Number of Participants Experiencing Spasms and Seizures by Subtype | Day 4 and Day 15 | Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizures included: clonic, tonic-clonic, myoclonic, focal, and absence. |
| Secondary | Average Time to Cessation of Spasms | Day 1 to start of Open-label Extension (OLE) Phase | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase (NCT02954887) for up to 1 year. |
| Secondary | Caregiver Clinical Global Impression of Change (CGIC) | Day 15 | The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse). |
| Secondary | Physician Global Impression of Change (PGIC) | Day 15 | The PGIC is a single-question assessment completed by the investigator. The question assesses the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse). |
| Secondary | Number of Responders | Baseline to Day 15 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Responders | Baseline to Day 15 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
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/NCT02953548/registered