Trial · NCT02299115
Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
NCT02299115, Phase 3, Withdrawn, The Hospital for Sick Children
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms. Trials, record NCT02299115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02299115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
- NCT number
- NCT02299115
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- The Hospital for Sick Children
- Conditions
- Infantile Spasms
- Interventions
- Prednisolone, Vigabatrin
- First posted
- 2014-11-24
- Last updated
- 2019-11-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resolution of Infantile spasms and Hypsarrhythmia | 14 days | Clinical response: cessation of spasms: no reported spasms for at least 48 hours including day 14 of the trial. EEG response: complete resolution of hypsarrhythmia or modified hypsarrhythmia pattern, on follow up EEG at approximately 2 weeks of the trial. |
| Secondary | Clinical or EEG relapse of Infantile Spasms | 6 months | Clinical relapse: any spasm occurring after 2 weeks up to and including final clinical assessment at approximately 5 months (+/- 2weeks) post-treatment in an infant who had cessation of spasms. EEG Relapse: recurrence of hypsarrhythmia/modified hypsarrhythmia pattern after one previous EEG showing resolution of hypsarrhythmia |
| Secondary | Seizure outcome at final follow up (presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit) | 6 months | Clinical assessment of the presence or absence of any seizure types at final follow up as assessed by seizure diary and on history at final follow up visit. |
| Secondary | Time to cessation of Infantile spasms | 14 days | Length of time in days to achieve cessation of Infantile spasms |
| Secondary | Time to relapse | 6 months | Length of time (in days) from the initial resolution of Infantile spasms to the relapse of Infantile spasms |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02299115
GET https://conductscience.org/api/trials/v1/NCT02299115/papers?page=2