Granted Patent
B2
US 12,740,959 · App. 17/926,472 · Granted Sep 22, 2026
Methods for the treatment of infantile spasms using medium chain triglycerides
Assignee:
CERECIN AUSTRALIA PTY LIMITED
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present disclosure relates to methods for the treatment of Infantile Spasms and/or the prevention of spasms of Infantile spasms. The methods include administering compositions comprising at least one compound capable of elevating ketone body concentrations in a subject in need thereof (e.g., ketogenic compounds), administered in an amount effective for treatment of Infantile Spasms and or the prevention of spams of Infantile Spasms. In one embodiment, the composition includes medium chain triglycerides (MCT). The composition may be administered as an oral dosage forms, in particular, a nutritional drink comprising at least one compound capable of elevating ketone body concentrations in a subject.
Claims (13)
1 . A method for the treatment of Infantile Spasms and/or the prevention of spasms of Infantile Spasms in a subject in need thereof, the method comprising: administering an effective amount of a composition comprising tricaprilin, wherein the tricaprilin is capable of elevating ketone body concentrations in the body of the subject.
2 . The method of claim 1 , wherein the composition is an emulsion.
3 . The method of claim 1 , wherein greater than 95% of the fatty acids of the tricaprilin are octanoic acid comprised of 8 carbons (C8).
4 . The method of claim 1 , wherein the composition is administered in an amount effective to treat Infantile Spasms in the subject.
5 . The method of claim 1 , wherein the composition is administered in an amount effective to reduce spasms of Infantile Spasm in the subject by at least 50%, when compared to no treatment.
6 . The method of claim 1 , wherein the composition is administered in an amount effective to reduce spasms of Infantile Spasm in the subject by at least 75%, when compared to no treatment.
7 . The method of claim 1 , wherein the composition is administered orally or intravenously.
8 . The method of claim 1 , wherein the composition is administered orally as a nutritional supplement.
9 . The method of claim 1 , wherein the tricaprilin is administered in an amount ranging from about 0.01 g/kg/day to about 30 g/kg/day in the composition.
10 . The method of claim 1 , wherein the tricaprilin is administered in an amount ranging from about 0.05 g/kg/day to about 20 g/kg/day in the composition.
11 . The method of claim 1 , wherein the composition is administered in single or divided doses.
12 . The method of claim 1 , wherein the composition is administered once, twice, or three times daily.
13 . The method of claim 1 , wherein the subject is a human.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 13, 2026
From: WALKER, JUDITH; HENDERSON, SAMUEL T.
To: CERECIN INC.
Reel/Frame 074646/0981 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 18, 2024
From: CERECIN INC.
To: CERECIN AUSTRALIA PTY LIMITED
Reel/Frame 066164/0570 →
Continuity (3)
Provisional Application
63176747
· Apr 19, 2021
Provisional Application
63032111
· May 29, 2020
References Cited (106)
US 7807718B2
· Hashim et al.
· 2010
[cited by applicant]
US 9789079B2
· Pan et al.
· 2017
[cited by applicant]
US 9795580B2
· Weeber et al.
· 2017
[cited by applicant]
US 20050228188A1
· Sumida
· 2005
[cited by examiner]
US 20070197645A1
· Martin et al.
· 2007
[cited by applicant]
US 20070281892A1
· Martin et al.
· 2007
[cited by applicant]
US 20080058416A1
· Greenwood et al.
· 2008
[cited by applicant]
US 20080249173A1
· Martin et al.
· 2008
[cited by applicant]
US 20170348276A1
· Bryson et al.
· 2017
[cited by applicant]
US 20190269699A1
· Reddy et al.
· 2019
[cited by applicant]
US 20200108040A1
· Kunugi et al.
· 2020
[cited by applicant]
US 20200215013A1
· Williams et al.
· 2020
[cited by applicant]
US 20220160297A1
· Wu et al.
· 2022
[cited by applicant]
US 20220184022A1
· Patin et al.
· 2022
[cited by applicant]
US 20230021730A1
· Cerne et al.
· 2023
[cited by applicant]
CN 1972697
· 2007
[cited by applicant]
CN 104736159
· 2015
[cited by applicant]
WO WO9841201
· 1998
[cited by applicant]
WO WO2006002121
· 2006
[cited by applicant]
WO WO2014031792
· 2014
[cited by applicant]
WO WO2016191651
· 2016
[cited by applicant]
WO WO2017204986
· 2017
[cited by applicant]
WO WO2018031748
· 2018
[cited by applicant]
WO WO2021233796
· 2021
[cited by applicant]
WO WO2022018094
· 2022
[cited by applicant]
WO WO2022096637
· 2022
[cited by applicant]
WO WO2022183292
· 2022
[cited by applicant]
WO WO2022232106
· 2022
[cited by applicant]
WO WO2022242882
· 2022
[cited by applicant]
WO WO2022242883
· 2022
[cited by applicant]
WO WO2022246572
· 2022
[cited by applicant]
WO WO2023001724
· 2023
[cited by applicant]
Hanifiha et al., “The efficacy of the ketogenic diet in improving seizures and eeg findings in patients with refractory infantile spasms,” Iranian Journal of Child Neurology, 2022, 16(4), 45-54.
[cited by examiner]
Dressler et al., “Efficacy and tolerability of the ketogenic diet versus high-dose adrenocorticotropic hormone for infantile spasms: a single-center parallel-cohort randomized controlled trial,” Epilepsia, 2019, 60(3), …
[cited by examiner]
Su et al., “SCN2A mutation in an infant presenting with migrating focal seizures and infantile spasm responsive to a ketogenic diet,” Brain & Development 40 (2018) 724- 727.
[cited by examiner]
Liu et al., “Medium-chain triglyceride ketogenic diet, an effective treatment for drug-resistant epilepsy and a comparison with other ketogenic diets,” Biomedical Journal 2013, 36(1), 9-15.
[cited by examiner]
Vandenberghe et al., “Tricaprylin Alone Increases Plasma Ketone Response More Than Coconut Oil or Other Medium-Chain Triglycerides: An Acute Crossover Study in Healthy Adults,” Curr Dev Nutr 2017;1:1-5.
[cited by examiner]
Cantillon et al., Ketogenic drug tricaprilin (CER-0001) for the treatment of refractory infantile epileptic spasms: a phase 1/2a study, Frontiers in Pediatrics, 13:1575014, Feb. 20, 2026.
[cited by examiner]
“Medium Chain Triglycerides [Monograph],” Altern Med Rev. 2002; 7: 418-420.
[cited by applicant]
Busner et al., “The clinical global impressions scale: applying a research tool in clinical practice,” Psychiatry, 2007, (Edgmont (Pa.: Township)), 4(7), 28-37.
[cited by applicant]
Buss et al., “Nonclinical safety and pharmacokinetics of miglyol 812: a medium chain triglyceride in exenatide once weekly suspension,” Journal of Applied Toxicology: Jat, 2018, 38(10), 1293-1301.
[cited by applicant]
Liu, “Medium-chain triglyceride (mct) ketogenic therapy,” Epilepsia, 2008, 49, S8, 33-36.
[cited by applicant]
Sampaio, “Ketogenic diet for epilepsy treatment,” Arquivos De Neuro-Psiquiatria, 2016, 74(10), 842-848.
[cited by applicant]
Sher et al., “Therapeutic efficacy of ACTH in symptomatic infantile spasms with hypsarrhythmia,” Pediatric Neurology 1993, 9(6), 451-6.
[cited by applicant]
Swift et al., “Medium-chain fatty acids: evidence for incorporation into chylomicron triglycerides in humans,” The American Journal of Clinical Nutrition, 1990, 52(5), pp. 834-836.
[cited by applicant]
Vandenplas et al., “Development of the brussels infant and toddler stool scale (‘bitss’): protocol of the study,” BMJ Open, 2017, 7(3).
[cited by applicant]
Wheless, J.W., et al., Infantile spasms (West syndrome): update and resources for pediatricians and providers to share with parents. BMC Pediatr, 2012. 12: p. 108.
[cited by applicant]
Kellaway, P., et al., Precise characterization and quantification of infantile spasms. Ann Neurol, 1979. 6(3): p. 214-8.
[cited by applicant]
Riikonen, R., Long-term outcome of West syndrome: a study of adults with a history of infantile spasms. Epilepsia, 1996. 37(4): p. 367-72.
[cited by applicant]
Watanabe, K., West syndrome: etiological and prognostic aspects. Brain Dev, 1998. 20(1): p. 1-8.
[cited by applicant]
Marshall, C.R., et al., Infantile spasms is associated with deletion of the MAGI2 gene on chromosome 7q11.23-q21.11. Am J Hum Genet, 2008. 83(1): p. 106-11.
[cited by applicant]
Michaud, J.L., et al., The genetic landscape of infantile spasms. Hum Mol Genet, 2014. 23(18): p. 4846-58.
[cited by applicant]
Zhongshu, Z., et al., Clinical analysis of West syndrome associated with phenylketonuria. Brain Dev, 2001. 23(7): p. 552-7.
[cited by applicant]
Stafstrom, C.E. and G.L. Holmes, Infantile spasms: criteria for an animal model. Int Rev Neurobiol, 2002. 49: p. 391-411.
[cited by applicant]
Pellock, J.M., et al., Infantile spasms: a U.S. consensus report. Epilepsia, 2010. 51(10): p. 2175-89.
[cited by applicant]
Scantlebury, M.H., et al., A model of symptomatic infantile spasms syndrome. Neurobiol Dis, 2010. 37(3): p. 604-12.
[cited by applicant]
Cortez, M.A., et al., Infantile spasms and Down syndrome: a new animal model. Pediatr Res, 2009. 65(5): p. 499-503.
[cited by applicant]
Baram, T.Z., et al., High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics, 1996. 97(3): p. 375-9.
[cited by applicant]
Prezioso, G., et al., Efficacy of ketogenic diet for infantile spasms: A systematic review. Acta Neurol Scand, 2018. 137(1): p. 4-11.
[cited by applicant]
Hrachovy, R.A., J.D. Frost, Jr., and D.G. Glaze, High-dose, long-duration versus low-dose, short-duration corticotropin therapy for infantile spasms. J Pediatr, 1994. 124(5 Pt 1): p. 803-6.
[cited by applicant]
Lux, A.L., et al., The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial. Lancet, 2004. 364(9447): p. 1773-8.
[cited by applicant]
Elterman, R.D., et al., Randomized trial of vigabatrin in patients with infantile spasms. Neurology, 2001. 57(8): p. 1416-21.
[cited by applicant]
Hrachovy, R.A., et al., Double-blind study of ACTH vs prednisone therapy in infantile spasms. J Pediatr, 1983. 103(4): p. 641-5.
[cited by applicant]
Eun, S.H., et al., Ketogenic diet for treatment of infantile spasms. Brain Dev, 2006. 28(9): p. 566-71.
[cited by applicant]
Kossoff, E.H., et al., A case-control evaluation of the ketogenic diet versus ACTH for new-onset infantile spasms. Epilepsia, 2008. 49(9): p. 1504-9.
[cited by applicant]
Hong, A.M., et al., Infantile spasms treated with the ketogenic diet: prospective single-center experience in 104 consecutive infants. Epilepsia, 2010. 51(8): p. 1403-7.
[cited by applicant]
Caraballo, R., et al., Long-term follow-up of the ketogenic diet for refractory epilepsy: multicenter Argentinean experience in 216 pediatric patients. Seizure, 2011. 20(8): p. 640-5.
[cited by applicant]
Numis, A.L., et al., The relationship of ketosis and growth to the efficacy of the ketogenic diet in infantile spasms. Epilepsy Res, 2011. 96(1-2): p. 172-5.
[cited by applicant]
Li, B., et al., Effects of ketogenic diet on the clinical and electroencephalographic features of children with drug therapy-resistant epilepsy. Exp Ther Med, 2013. 5(2): p. 611-615.
[cited by applicant]
Lee, J., et al., Prognostic factors of infantile spasms: role of treatment options including a ketogenic diet. Brain Dev, 2013. 35(8): p. 821-6.
[cited by applicant]
Pires, M.E., et al., Ketogenic diet for infantile spasms refractory to first-line treatments: an open prospective study. Epilepsy Res, 2013. 105(1-2): p. 189-94.
[cited by applicant]
Kayyali, H.R., et al., Ketogenic diet efficacy in the treatment of intractable epileptic spasms. Pediatr Neurol, 2014. 50(3): p. 224-7.
[cited by applicant]
Hirano, Y., et al., Ketogenic diet therapy can improve ACTH-resistant West syndrome in Japan. Brain Dev, 2015. 37(1): p. 18-22.
[cited by applicant]
Hussain, S.A., et al., Limited efficacy of the ketogenic diet in the treatment of highly refractory epileptic spasms. Seizure, 2016. 35: p. 59-64.
[cited by applicant]
O'Callaghan, F.J., et al., The effect of lead time to treatment and of age of onset on developmental outcome at 4 years in infantile spasms: evidence from the United Kingdom Infantile Spasms Study. Epilepsia, 2011. 52(7…
[cited by applicant]
Go, C.Y., et al., Evidence-based guideline update: medical treatment of infantile spasms. Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neu…
[cited by applicant]
Groleau, V., et al., Long-term impact of the ketogenic diet on growth and resting energy expenditure in children with intractable epilepsy. Dev Med Child Neurol, 2014. 56(9): p. 898-904.
[cited by applicant]
Shaw, D.M., et al., Exogenous Ketone Supplementation and Keto-Adaptation for Endurance Performance: Disentangling the Effects of Two Distinct Metabolic States. Sports Med, 2020. 50(4): p. 641-656.
[cited by applicant]
Poff, A.M., A.P. Koutnik, and B. Egan, Nutritional Ketosis with Ketogenic Diets or Exogenous Ketones: Features, Convergence, and Divergence. Curr Sports Med Rep, 2020. 19(7): p. 251-259.
[cited by applicant]
Sharman, M.J., et al., A ketogenic diet favorably affects serum biomarkers for cardiovascular disease in normal-weight men. J Nutr, 2002. 132(7): p. 1879-85.
[cited by applicant]
Wiemer-Kruel A: “Ketogenic diets”, Zeitschrift Fur Epileptologie, Springer Berlin Heidelberg, Berlin/Heidelberg, vol. 26, No. 3, Aug. 2, 2013 (Aug. 2, 2013), pp. 160-166.
[cited by applicant]
Mackay et al., “Practice Parameter: Medical Treatment of Infantile Spasms,” Neurology, May 25, 2004, 62(1): 1668-1681.
[cited by applicant]
Smith et al., “Infantile Spasms,” NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; Mar. 10, 2023, 9 pages.
[cited by applicant]