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NCT04172311: LEVEMAD
Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy
Phase 2, PHASE3 trial testing Modified Atkins Diet in Refractory Childhood Epilepsy in 90 participants. Status unknown.
31 March 2021
Quick facts
| Lead sponsor | Lady Hardinge Medical College |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 14 November 2019 |
| Primary completion | 31 March 2021 |
| Estimated completion | 20 April 2021 |
| Sites | 1 location across India |
Drugs / interventions tested
- Modified Atkins Diet
- Levetiracetam (levetiracetam) — full drug profile →
Conditions studied
- Refractory Childhood Epilepsy — all drugs for Refractory Childhood Epilepsy →
Sponsor
Lady Hardinge Medical College
Who can join
Adults 2 to 12, any sex, with Refractory Childhood Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, the efficacy of add-on modified Atkins diet will be compared with add-on Levetiracetam in children with refractory epilepsy in a randomized open label trial. The results will aid clinicians in deciding the treatment options when a child has been diagnosed to have refractory epilepsy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Modified Atkins diet versus levetiracetam for non-surgical drug-resistant epilepsy in children: A randomized open-label study.
Archna, Garg D, Goel S, Mukherjee SB, et al · · 2022 · cited 9× · PMID 36306706 · DOI 10.1016/j.seizure.2022.10.015
Verify or expand the search:
- PubMed search for NCT04172311
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Modified Atkins Diet
Trials testing the same drug.
- NCT04274179 — Ketogenic Diet for New-Onset Absence Epilepsy · Phase 3 · recruiting
- NCT04193891 — The Effect of Ketogenic Dietary Therapy on Sleep in Adult Epilepsy · terminated
Other Lady Hardinge Medical College trials
Trials by the same sponsor.
- NCT05958160 — Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized · Phase 2, PHASE3 · unknown
- NCT06197269 — Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis · NA · completed
- NCT06090981 — Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome · NA · completed
- NCT06076460 — Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation · NA · completed
- NCT06090968 — Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04172311 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lady Hardinge Medical College
- Last refreshed: 21 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04172311.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing