Trial · NCT04302116
Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
NCT04302116, Not applicable, Recruiting, Kullasate Sakpichaisakul
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm. Trials, record NCT04302116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04302116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
- NCT number
- NCT04302116
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Kullasate Sakpichaisakul
- Conditions
- Infantile Spasm, West Syndrome
- Interventions
- Combination therapy with vigabatrin and prednisolone, Vigabatrin Tablets
- First posted
- 2020-03-10
- Last updated
- 2021-08-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cessation of spasms | Assessed during Day 14 to Day 42 after treatment. | Defined as no witnessed spasms (either clusters or single spasms) from Day 14 to Day 42 inclusive. |
| Secondary | Electrographic response | Assessed during Day 14 and Day 43 after treatment. | Disappearance of hypsarrhythmia defined by Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system \< 2 at Day 14 and Day 43 after treatment. |
| Secondary | Electroclinical response | Between Day 14 and Day 21. | the cessation of spasms with the addition of absence of hypsarrhythmia (BASED score \< 2) on the Day 14 EEG. Valid Day 14 EEGs will be undertaken between Day 14 and Day 21 inclusive. |
| Secondary | Extended electroclinical response | Between Day 42 and Day 49. | Electroclinical response with the addition of absence of hypsarrhythmia (BASED score \< 2) on the Day 42 EEG. Valid Day 42 EEGs will be undertaken between Day 42 and Day 49 inclusive. |
| Secondary | The time taken to absence of spasms | Day 1 to Day 14 | Duration for clinical cessation of spasms after initiation treatment |
| Secondary | Relapse of spasms | Day 42 to 3 months after treatment | Defined when a cluster of more than one spasm in reported after Day 42. No EEG is required. |
| Secondary | Adverse reactions | Day 1 to Day 14, from Day 15 to Day 42, and from Day 43 to 4 months into the trial | Each adverse event will be evaluated by the principal investigator to determine whether in their view it is an adverse reaction. If considered an adverse reaction, it will be reported by using the standard classification. |
| Secondary | Epilepsy outcome at age 18 months | From Day 42 to age 18 months | Epilepsy status and antiepileptic drugs (AEDs) will be recorded by using the following categories: 1) Infantile spasms (clusters of spasms), 2) Any other epileptic seizure including febrile seizures, and 3) Names of any preventive AEDs prescribed |
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.
Papers27
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/NCT04302116
GET https://conductscience.org/api/trials/v1/NCT04302116/papers?page=2