Trial · NCT02551731
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14 | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14. |
| Primary | Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs) | Up to Week 64 | |
| Secondary | Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14 | Day 14 | |
| Secondary | Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14 | Day 14 | |
| Secondary | Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 | Baseline, Day 14 | |
| Secondary | Part A: Parent Impression of Efficacy and Tolerability of Study Drug | Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. | Parent impression of efficacy and tolerability, as measured by Clinical Global Impression-Global Improvement Scale (CGI-I), was summarized by visit and status of response (Complete/Partial and No Response) at Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. The CGI-I was also analyzed in a continuous scale, as follows: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse |
| Secondary | Part A: Percentage of Participants With a Partial Response to Treatment | Day 14 | Partial response was defined as a substantive change in background EEG or reduction in spasms on video EEG obtained at Day 14. |
| Secondary | Part A: Percentage of Complete Responders With Relapse | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. |
| Secondary | Part A: Time to Complete Responder Relapse | Day 14 | Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14. |
| Secondary | Part B: Parent Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in Clinical Global Impression of Improvement Assessment (CGI-I), Responses at Every Visit Throughout Part B | Up to Week 64 | |
| Secondary | Part B: Investigator Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in CGI-I Responses at Every Visit Throughout Part B | Up to Week 64 | |
| Secondary | Part B: Median Reduction in Seizure-burden Comparing Seizure Diaries Throughout Part B. | Up to Week 64 | |
| Secondary | Part B: Percentage of Participants Who Have a Relapse of Spasms Based on Video-EEG | Up to Week 64 | |
| Secondary | Part B: Time to Relapse as Confirmed by Video-EEG | Up to Week 64 |
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/NCT02551731/registered