Trial · NCT05279118
Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
NCT05279118, Phase 2, Phase 3, Unknown, All India Institute of Medical Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome. Trials, record NCT05279118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05279118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
- NCT number
- NCT05279118
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 80 participants, estimated
- Lead sponsor
- All India Institute of Medical Sciences
- Conditions
- Ketogenic Diet, West Syndrome, Infantile Spasm, ACTH
- Interventions
- Ketogenic diet, ACTH
- First posted
- 2022-03-15
- Last updated
- 2024-06-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms | From baseline to 6 weeks of therapy | Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate \* 100) is compared in both arms |
| Secondary | To compare complete spasm cessation rate in KD arm vs ACTH arm | Percentage of children with clinical spasm cessation at 6 weeks of therapy | Percentage of children with clinical spasm cessation at 6 weeks of therapy |
| Secondary | To compare >50% spasm reduction rate in KD arm vs ACTH arm | Percentage of children with >50% spasm reduction at the end of 6 weeks and 3months of therapy (wherever feasible at 6 months) | Percentage of children with \>50% spasm reduction at the end of 6 weeks and 3months of therapy (wherever feasible at 6 months) |
| Secondary | To compare electroclinical spasm To compare electroclinical spasm cessation rate in KD arm vs ACTH arm at 6 weeks | Percentage of children with clinical spasm cessation at 6 weeks of therapy | Percentage of children with clinical spasm cessation at 6 weeks of therapy |
| Secondary | To compare sustained electroclinical cessation rate in KD arm vs ACTH arm at 3 months | Percentage of children with primary electroclinical spasm cessation who sustain the remission at 3months of therapy(wherever feasible at 6 months) | Percentage of children with primary electroclinical spasm cessation who sustain the remission at 3months of therapy(wherever feasible at 6 months) |
| Secondary | To compare the compliance rate in KD arm vs ACTH arm at 6 weeks | Percentage of children with compliance of greater than >80% of doses of ACTH in the 6 weeks of therapy compared with percentage of children with score of >80% in KD compliance questionnaire (score of >/=18 out of 25) | Percentage of children with compliance of greater than \>80% of doses of ACTH in the 6 weeks of therapy compared with percentage of children with score of \>80% in KD compliance questionnaire (score of \>/=18 out of 25) |
| Secondary | To compare the adverse effect profile in KD arm vs ACTH arm at 6 weeks and 3 months | Description of adverse effects in each groups with proportion of CTCAE grade 3 and above in each groups at 3months of therapy (wherever feasible at 6 months) | Description of adverse effects in each groups with proportion of CTCAE grade 3 and above in each groups at 3months of therapy (wherever feasible at 6 months) |
| Secondary | To compare neurodevelopmental outcome in KD arm vs ACTH arm using DASII at 3 months | Percentage improvement in Motor and Mental developmental quotients of children in both groups at 3 months of therapy (wherever feasible at 6 months) | Percentage improvement in Motor and Mental developmental quotients of children in both groups at 3 months of therapy (wherever feasible at 6 months) |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05279118
GET https://conductscience.org/api/trials/v1/NCT05279118/registered